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BioAge Labs, Inc.

For the period ended Sep 30, 2025. Filed Nov 6, 2025.

View on SEC.gov

About this filing

A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.

Sep 30, 2025 · Filed Nov 6, 2025

BIOA$5.34-3.6%Stored close · as of Nov 6, 2026

What changed in Management’s Discussion and Analysis?

Read the current filing

Previous report: 10-Q

Period ended 2025-06-30; filed 2025-08-06.

0000950170-25-104176

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

Current report: 10-Q

Period ended 2025-09-30; filed 2025-11-06.

0001193125-25-270012

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

The baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.

Compared 161 previous paragraphs and 164 current paragraphs.

123 unchanged; 34 reworded; 5 added; 3 removed; 1 previous and 2 current paragraphs rearranged.

Tables are not compared: 5 previous and 5 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.

A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.

Added paragraphs (5)

Current report

explore additional indications for our existing product candidates;

Current report

On July 4, 2025, the U.S. government enacted the One Big Beautiful Bill Act (the "OBBBA"), which includes several changes to U.S. federal income tax law, including temporary and permanent extension, of expiring provisions of the Tax Cuts and Jobs Act of 2017. Beginning with our 2025 tax year, the OBBBA restored immediate deductibility of domestic expenditures, while foreign expenditures will continue to be capitalized and amortized over fifteen years. The impacts of the OBBBA are not expected to be material to the 2025 financial statements, however, we will continue to evaluate impacts to future periods.

Current report

Comparison of the nine months ended September 30, 2025 and 2024
Removed paragraphs (3)

Previous report

In January 2025, we announced the nomination of our lead program, BGE-102, a structurally novel, orally available small molecule NLRP3 inhibitor with high potency and brain penetration. We are initially developing BGE-102 for obesity since NLRP3-driven inflammation in the brain has been shown to dysregulate energy intake. In preclinical models, BGE-102 demonstrated weight loss both as a monotherapy and in combination with a GLP-1R agonist.

Previous report

On July 4, 2025, the One Big Beautiful Bill Act (“OBBBA”) was signed into law. This legislation includes changes to U.S. federal tax law, which may be subject to further clarification and the issuance of interpretive guidance. We are assessing the legislation and its effect on its consolidated financial statements. However, due to the existence of a full valuation allowance against our U.S. federal deferred tax assets, we do not currently expect the enactment of the OBBBA to have a material impact on our consolidated financial statements. We will continue to analyze the OBBBA and will reflect any impact in the period of enactment.
Reworded paragraphs (34)

Previous wording

We are a biopharmaceutical company developing therapeutic product candidates for metabolic diseases, such as obesity, by targeting the biology of human aging. Our technology platform and differentiated human datasets enable us to identify promising targets based on insights into molecular changes that drive aging. The primary focus of our portfolio is mechanisms that complement GLP-1 agonists and address key unmet needs. Among our therapeutic goals is the potential development of an all-oral combination product for obesity.

Current wording

We are a clinical-stage biopharmaceutical company developing therapeutic product candidates for metabolic diseases by targeting the biology of human aging. Our lead product candidate, BGE-102, is a potent, orally available, brain-penetrant small-molecule NLRP3 inhibitor being developed for obesity and cardiovascular risk factors. BGE-102 has demonstrated significant weight loss in preclinical models both as monotherapy and in combination with GLP-1 receptor agonists. Our technology platform and differentiated human datasets enable identification of promising targets based on insights into molecular changes that drive aging. The primary focus of our portfolio is mechanisms that complement GLP-1 agonists and address key unmet needs. Among our therapeutic goals is the potential development of an all-oral combination product for obesity.

Previous wording

In May 2025, we announced the completion of Investigational New Drug application ("IND") enabling activities for BGE-102. We intend to initiate a Phase 1 Single Ascending Dose (SAD) / Multiple Ascending Dose (MAD) clinical trial for BGE-102 in the second half of 2025, with initial Phase 1 SAD data anticipated by year-end 2025 and complete phase 1 results by mid-2026. We intend to initiate an obesity proof-of-concept clinical trial for BGE-102 in the first half of 2026, with data for this study anticipated in the second half of 2026.

Current wording

In August 2025, we announced that the first patient was dosed in our Phase 1 Single Ascending Dose (“SAD”) / Multiple Ascending Dose (“MAD”) clinical trial for BGE-102. The Phase 1 study is a randomized, double-blind, placebo-controlled trial designed to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of BGE-102 in healthy participants. The study is designed to characterize BGE-102's pharmacokinetic profile through blood sampling, assess CNS penetration through cerebrospinal fluid sampling, and evaluate pharmacodynamic effects using an ex vivo whole blood stimulation assay that measures BGE-102's ability to inhibit the production of key inflammatory signals such as IL-1β. Initial Phase 1 SAD data is anticipated by year-end 2025 and complete phase 1 results are anticipated by mid-2026. Following successful completion of the Phase 1 SAD/MAD clinical trial, we plan to initiate a proof-of-concept clinical trial for BGE-102, with top-line data for this study anticipated in the second half of 2026.

Previous wording

We have incurred significant operating losses and negative cash flows since inception. Our ability to generate product revenue sufficient to achieve profitability will depend heavily on the successful development and eventual commercialization of any future product candidates. Our net losses were $34.5 million and $26.6 million for the six months ended June 30, 2025 and 2024, respectively. As of June 30, 2025, we had an accumulated deficit of $287.3 million. We expect to continue to incur net operating losses for the foreseeable future, and we expect our research and development expenses, general and administrative expenses, and capital expenditures will increase substantially in connection with our ongoing activities, particularly if, and as, we:

Current wording

We have incurred significant operating losses and negative cash flows since inception. Our ability to generate product revenue sufficient to achieve profitability will depend heavily on the successful development and eventual commercialization of any future product candidates. Our net losses were $54.7 million and $50.0 million for the nine months ended September 30, 2025 and 2024, respectively. As of September 30, 2025, we had an accumulated deficit of $307.5 million. We expect to continue to incur net operating losses for the foreseeable future, and we expect our research and development expenses, general and administrative expenses, and capital expenditures will increase substantially in connection with our ongoing activities, particularly if, and as, we:

Current wording

continue to progress the development of our lead product candidate, BGE-102;

Previous wording

manufacture, or have manufactured, preclinical, clinical and potentially commercial supplies of any future product candidates;

Current wording

manufacture, or have manufactured, preclinical, clinical and potentially commercial supplies of BGE-102 and any future product candidates;

Previous wording

seek regulatory approvals for any future product candidates that successfully complete clinical trials, if any;

Current wording

seek regulatory approvals for BGE-102 or for any future product candidates that successfully complete clinical trials, if any;

Previous wording

As a result, we will need substantial additional funding to support our continuing operations and pursue our growth strategy. Until such time, if ever, as we can generate substantial product revenues, we expect to finance our cash needs through equity offerings, debt financings or other capital sources, which could include licenses, collaborations, or other strategic partnerships. Adequate additional funds may not be available to us on acceptable terms, or at all. To the extent that we raise additional capital through the sale of equity or convertible debt securities, the ownership interests of our existing stockholders may be diluted, and the terms of these securities may include liquidation or other preferences that could adversely affect the rights of such stockholders. Debt financing, if available, may involve agreements that include restrictive covenants that limit our ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends, which could adversely impact our ability to conduct our business. If we raise additional funds through licenses, collaborations, or other strategic partnerships with third parties, we may have to relinquish valuable rights to our technologies, future revenue streams, research program or product candidates, or grant licenses on terms that may not be favorable to us. If we are unable to raise additional funds through equity or debt financings when needed, we may be required to delay, limit, reduce or terminate our product development or future commercialization efforts or grant rights to develop and market product candidates that we would otherwise prefer to develop and market ourselves. There is no assurance that we will ever be profitable or generate positive cash flow from operating activities. Our ability to raise additional funds may also be adversely impacted by potential worsening global macroeconomic, industry and market conditions in either domestic or international markets, as well as economic conditions specifically affecting industries in which we operate, including but not limited to, actual or perceived instability in the banking industry, potential uncertainty with respect to the U.S. federal debt ceiling and budget and potential government shutdowns related thereto, labor shortages, supply chain disruptions, potential recession, inflation and changing interest rates, significant trade or regulatory developments, including tariffs or shifting priorities within the U.S. Food and Drug Administration, and political instability and military hostilities in multiple geographies, such as the conflicts in Ukraine, the Middle East, and tensions between China and Taiwan.

Current wording

As a result, we will need substantial additional funding to support our continuing operations and pursue our growth strategy. Until such time, if ever, as we can generate substantial product revenues, we expect to finance our cash needs through equity offerings, debt financings or other capital sources, which could include licenses, collaborations, or other strategic partnerships. Adequate additional funds may not be available to us on acceptable terms, or at all. To the extent that we raise additional capital through the sale of equity or convertible debt securities, the ownership interests of our existing stockholders may be diluted, and the terms of these securities may include liquidation or other preferences that could adversely affect the rights of such stockholders. Debt financing, if available, may involve agreements that include restrictive covenants that limit our ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends, which could adversely impact our ability to conduct our business. If we raise additional funds through licenses, collaborations, or other strategic partnerships with third parties, we may have to relinquish valuable rights to our technologies, future revenue streams, research program or product candidates, or grant licenses on terms that may not be favorable to us. If we are unable to raise additional funds through equity or debt financings when needed, we may be required to delay, limit, reduce or terminate our product development or future commercialization efforts or grant rights to develop and market product candidates that we would otherwise prefer to develop and market ourselves. There is no assurance that we will ever be profitable or generate positive cash flow from operating activities. Our ability to raise additional funds may also be adversely impacted by potential worsening global macroeconomic, industry and market conditions in either domestic or international markets, as well as economic conditions specifically affecting industries in which we operate, including but not limited to, actual or perceived instability in the banking industry, potential uncertainty with respect to the U.S. federal debt ceiling and budget and the ongoing federal government shutdown and any future government shutdowns related thereto, labor shortages, supply chain disruptions, potential recession, inflation and changing interest rates, significant trade or regulatory developments, including tariffs or shifting priorities within the U.S. Food and Drug Administration, and political instability and military hostilities in multiple geographies, such as the conflicts in Ukraine, the Middle East, and tensions between China and Taiwan.

Previous wording

As of June 30, 2025, we had $313.4 million in cash, cash equivalents, and marketable securities, of which $16.1 million were long-term marketable securities. Based on our current operating plan, we estimate that our existing cash, cash equivalents, and marketable securities as of the date of this Quarterly Report will be sufficient to fund our operations and capital expenses through 2029. However, 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 the section titled "Liquidity and Capital Resources" included elsewhere in this Quarterly Report.

Current wording

As of September 30, 2025, we had $295.9 million in cash, cash equivalents, and marketable securities, of which $10.1 million were long-term marketable securities. Based on our current operating plan, we estimate that our existing cash, cash equivalents, and marketable securities as of the date of this Quarterly Report will be sufficient to fund our operations and capital expenses through 2029. However, 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 the section titled "Liquidity and Capital Resources" included elsewhere in this Quarterly Report.

Previous wording

Collaboration revenue of $2.4 million and $3.9 million was recognized under the Novartis Agreement in the three and six months ended June 30, 2025, respectively. No collaboration revenue was recognized under the Novartis Agreement in the three and six months ended June 30, 2024. During the six months ended June 30, 2025, we recorded $2.9 million in revenue that was included in deferred revenue as of December 31, 2024 and $1.0 million in revenue related to research funding for reimbursable costs incurred during the six months ended June 30, 2025. Deferred revenue related to the Novartis Agreement amounted to $9.6 million and $12.5 million as of June 30, 2025, and December 31, 2024, respectively, of which $7.7 million and $7.8 million, respectively, was included in current liabilities within the unaudited condensed consolidated balance sheets.

Current wording

Collaboration revenue of $2.1 million and $5.9 million was recognized under the Novartis Agreement in the three and nine months ended September 30, 2025, respectively. No collaboration revenue was recognized under the Novartis Agreement in the three and nine months ended September 30, 2024. During the nine months ended September 30, 2025, we recorded $4.4 million in revenue that was included in deferred revenue as of December 31, 2024 and $1.5 million in revenue related to research funding for reimbursable costs incurred during the nine months ended September 30, 2025. Deferred revenue related to the Novartis Agreement amounted to $8.1 million and $12.5 million as of September 30, 2025, and December 31, 2024, respectively, of which $7.5 million and $7.8 million, respectively, was included in current liabilities within the unaudited condensed consolidated balance sheets.

Previous wording

We have not generated any product revenue since our inception and do not expect to generate any revenue from the sale of products in the near future, if at all. If our development efforts for BGE-102 or other product candidates that we may develop in the future are successful and result in marketing approval, we may generate revenue from product sales.

Current wording

We have not generated any product revenue since our inception and do not expect to generate any revenue from the sale of products in the near future, if at all. If our development efforts for our lead product candidate, BGE-102, or other product candidates that we may develop in the future are successful and result in marketing approval, we may generate revenue from product sales.

Previous wording

Research and development expenses account for a significant portion of our operating expenses and consist primarily of costs incurred in connection with the discovery, preclinical development, clinical development and manufacturing of our former lead product candidate, azelaprag, our current lead product candidate, BGE-102, and other potential future product candidates, and include:

Current wording

Research and development expenses account for a significant portion of our operating expenses and consist primarily of costs incurred in connection with the discovery, preclinical development, clinical development and manufacturing of our former lead product candidate, azelaprag, our lead product candidate, BGE-102, and other potential future product candidates, and include:

Previous wording

Research and development activities are central to our business model. We expect that our research and development expenses will continue to increase substantially for the foreseeable future as we progress BGE-102 into clinical trials, continue to discover and develop additional product candidates, expand our headcount and costs related to our existing and potential future intellectual property licenses. Later stages of clinical development generally have higher development costs than those in earlier stages, primarily due to the increased size and duration of later-stage clinical trials. There are numerous factors associated with the successful development and commercialization of any product candidates we may develop in the future, including future trial design and various regulatory requirements, many of which cannot be determined with accuracy at this time based on our stage of development. Additionally, future commercial and regulatory factors beyond our control will impact our clinical development program and plans.

Current wording

Research and development activities are central to our business model. We expect that our research and development expenses will continue to increase substantially for the foreseeable future as we progress BGE-102 into additional clinical trials, continue to discover and develop additional product candidates, expand our headcount and costs related to our existing and potential future intellectual property licenses. Later stages of clinical development generally have higher development costs than those in earlier stages, primarily due to the increased size and duration of later-stage clinical trials. There are numerous factors associated with the successful development and commercialization of any product candidates we may develop in the future, including future trial design and various regulatory requirements, many of which cannot be determined with accuracy at this time based on our stage of development. Additionally, future commercial and regulatory factors beyond our control will impact our clinical development program and plans.

Previous wording

Changes in the outcome of any of these variables with respect to the development of any future product candidates in preclinical and clinical development could mean a significant change in the costs and timing associated with the development of these product candidates. For example, if the FDA, European Medicines Agency or another regulatory authority were to delay our planned start of clinical trials or require us to conduct clinical trials or other testing beyond those that we currently expect, or if we experience significant delays in enrollment in any clinical trials following the applicable regulatory authority’s acceptance and clearance, we could be required to expend significant additional financial resources and time to complete clinical development than we currently expect. We may never obtain regulatory approval for any product candidates that we develop.

Current wording

Changes in the outcome of any of these variables with respect to the development of our lead product candidate, BGE-102, or any future product candidates in preclinical and clinical development could mean a significant change in the costs and timing associated with the development of these product candidates. For example, if the FDA, European Medicines Agency or another regulatory authority were to delay our planned start of clinical trials or require us to conduct clinical trials or other testing beyond those that we currently expect, or if we experience significant delays in enrollment in any clinical trials following the applicable regulatory authority’s acceptance and clearance, we could be required to expend significant additional financial resources and time to complete clinical development than we currently expect. We may never obtain regulatory approval for any product candidates that we develop.

Previous wording

The successful development of any product candidates we may develop in the future is highly uncertain. Therefore, we cannot reasonably estimate or know the nature, timing and estimated costs of the efforts that will be necessary to complete the development and commercialization of any future product candidates we may develop. We are also unable to predict when, if ever, material net cash inflows will commence from the sale of any future product candidate, if approved. This is due to the numerous risks and uncertainties associated with product development.

Current wording

The successful development of BGE-102 or any other product candidates we may develop in the future is highly uncertain. Therefore, we cannot reasonably estimate or know the nature, timing and estimated costs of the efforts that will be necessary to complete the development and commercialization of BGE-102 and any future product candidates we may develop. We are also unable to predict when, if ever, material net cash inflows will commence from the sale of BGE-102 or any future product candidate, if approved. This is due to the numerous risks and uncertainties associated with product development.

Previous wording

Collaboration Revenue for the three months ended June 30, 2025 was $2.4 million, compared to no collaboration revenue for the three months ended June 30, 2024. The $2.4 million increase in collaboration revenue was the result of revenue recognized under the Novartis Agreement, as work commenced in 2025.

Current wording

Collaboration Revenue for the three months ended September 30, 2025 was $2.1 million, compared to no collaboration revenue for the three months ended September 30, 2024. The $2.1 million increase in collaboration revenue was the result of revenue recognized under the Novartis Agreement, as work commenced in 2025.

Previous wording

Research and development expenses increased by $9.3 million from $10.5 million for the three months ended June 30, 2024 to $19.8 million for the three months ended June 30, 2025. The increase in research and development expenses was primarily attributable to a $8.0 million increase in direct costs for other programs, which was primarily related to licensing, discovery, and development activities related to our novel apelin receptor APJ agonist programs during the three months ended June 30, 2025. Additionally contributing to the increase in research and development expenses was a $3.0 million increase in direct costs related to our BGE-102 program associated with IND-enabling activities and drug-product manufacturing. These higher costs were partially offset by a $1.7 million reduction in azelaprag direct costs as development was terminated in January 2025.

Current wording

Research and development expenses decreased by $1.5 million from $20.0 million for the three months ended September 30, 2024 to $18.5 million for the three months ended September 30, 2025. The decrease in research and development expenses was primarily attributable to a $13.1 million reduction in azelaprag direct costs as development was terminated in January 2025. The decrease in azelaprag research and development expenses was partially offset by a $6.5 million increase in direct costs for other programs, which was primarily related to discovery and development activities related to our novel apelin receptor APJ agonist programs, a $4.4 million increase in direct costs related to our BGE-102 program associated with our ongoing Phase 1 SAD/MAD clinical trial and drug-product manufacturing, and a $0.8 million increase in allocated facility and other expenses primarily driven by an increase in non-program specific consulting fees.

Previous wording

General and administrative expenses increased by $2.5 million from $4.8 million for the three months ended June 30, 2024 to $7.3 million for the three months ended June 30, 2025. The increase was primarily driven by a $1.5 million increase personnel-related expenses, largely due to an increase in stock-based compensation expense associated with new option grants issued to employees, executives, board members and advisors. Additionally contributing to the increase in general and administrative expenses was a $0.9 million increase in legal fees.

Current wording

General and administrative expenses increased by $2.0 million from $4.7 million for the three months ended September 30, 2024 to $6.7 million for the three months ended September 30, 2025. The increase was primarily driven by a $0.8 million increase in legal fees, a $0.5 million increase personnel-related expenses, largely due to an increase in stock-based compensation expense associated with new option grants issued to employees, executives, board members and advisors, a $0.3 million increase in taxes and insurance, primarily related to our public-company director and officer insurance policy.

Previous wording

Other income (expense), net increased by approximately $1.5 million from $1.7 million for the three months ended June 30, 2024 to $3.2 million for the three months ended June 30, 2025. This increase in other income was primarily attributable to a $1.2 million increase in interest income driven by our higher cash, cash equivalents, and marketable securities balance. Further contributing to the increase in other income was a $0.2 million decrease in interest expense primarily related to our convertible promissory notes that converted into Series D-1 redeemable convertible preferred stock in February 2024

Current wording

Other income (expense), net increased by approximately $1.7 million from $1.3 million for the three months ended September 30, 2024 to $3.0 million for the three months ended September 30, 2025. This increase in other income was primarily attributable to a $1.1 million increase in interest income driven by our higher cash, cash equivalents, and marketable securities balance. Further contributing to the increase in other income was a $0.2 million decrease in interest expense primarily related to the reduction in outstanding principal balance under the Term Loan, and a $0.3 million decrease in loss from changes in fair value on warrants.

Previous wording

Collaboration Revenue for the six months ended June 30, 2025 was $3.9 million, compared to no collaboration revenue for the six months ended June 30, 2024. The $3.9 million increase in collaboration revenue was the result of revenue recognized under the Novartis Agreement, as work commenced in 2025.

Current wording

Collaboration Revenue for the nine months ended September 30, 2025 was $5.9 million, compared to no collaboration revenue for the nine months ended September 30, 2024. The $5.9 million increase in collaboration revenue was the result of revenue recognized under the Novartis Agreement, as work commenced in 2025.

Previous wording

Research and development expenses increased by $11.2 million from $19.8 million for the six months ended June 30, 2024 to $31.0 million for the six months ended June 30, 2025. The increase in research and development expenses was primarily attributable to a $8.5 million increase in direct costs related to other programs, which was primarily related to licensing, discovery, and development activities related to our novel apelin receptor APJ agonist programs during the six months ended June 30, 2025. Additionally contributing to the increase in research and development expenses was a $5.2 million increase in direct costs related to our BGE-102 program associated with IND-enabling activities and drug-product manufacturing and a $1.5 million increase in personnel-related expenses, driven by stock-based compensation grants to employees and severance payments to certain former employees, and a $0.4 million increase in allocated facility and other expenses primarily related to facility expenses for our Emeryville Lease (defined below). These higher costs were partially offset by a $4.4 million reduction in azelaprag direct costs as development was terminated in January 2025.

Current wording

Research and development expenses increased by $9.7 million from $39.8 million for the nine months ended September 30, 2024 to $49.5 million for the nine months ended September 30, 2025. The increase in research and development expenses was primarily attributable to a $15.0 million increase in direct costs related to other programs, which was primarily related to licensing, discovery, and development activities related to our novel apelin receptor APJ agonist programs during the nine months ended September 30, 2025. Additionally, direct costs related to our BGE-102 program increased $9.5 million associated with IND-enabling activities, drug-product manufacturing, and our ongoing Phase 1 SAD/MAD clinical trial.

Previous wording

General and administrative expenses increased by $5.8 million from $8.3 million for the six months ended June 30, 2024 to $14.1 million for the six months ended June 30, 2025. The increase was primarily driven by a $3.5 million increase personnel-related expenses, largely due to an increase in stock-based compensation expense associated with new option grants issued to employees, executives, board members and advisors. Additionally contributing to the increase in general and administrative expenses was a $1.4 million increase in legal fees and a $0.7 million increase in taxes and insurance, primarily related to our public-company director and officer insurance policy.

Current wording

General and administrative expenses increased by $7.8 million from $13.0 million for the nine months ended September 30, 2024 to $20.8 million for the nine months ended September 30, 2025. The increase was primarily driven by a $4.0 million increase personnel-related expenses, largely due to an increase in stock-based compensation expense associated with new option grants issued to employees, executives, board members and advisors. Additionally contributing to the increase in general and administrative expenses was a $2.2 million increase in legal fees and a $1.0 million increase in taxes and insurance, primarily related to our public-company director and officer insurance policy.

Previous wording

Other income (expense), net increased by approximately $5.2 million from $1.5 million for the six months ended June 30, 2024 to $6.7 million for the six months ended June 30, 2025 and 2024. This increase in other income was primarily attributable to a $3.6 million increase in interest income driven by our higher cash, cash equivalents, and marketable securities balance. Further contributing to the increase in other income was a $1.2 million decrease in interest expense and a $0.3 million decrease in loss on extinguishment of debt related to our convertible promissory notes that converted into Series D-1 redeemable convertible preferred stock in February 2024.

Current wording

Other income (expense), net increased by approximately $6.8 million from $2.9 million for the nine months ended September 30, 2024 to $9.7 million for the nine months ended September 30, 2025. This increase in other income was primarily attributable to a $4.8 million increase in interest income driven by our higher cash, cash equivalents, and marketable securities balance. Further contributing to the increase in other income was a $1.4 million decrease in interest expense, a $0.3 million decrease in loss on extinguishment of debt related to our convertible promissory notes that converted into Series D-1 redeemable convertible preferred stock in February 2024, and a $0.4 million decrease in loss from changes in fair value on warrants.

Previous wording

Since our inception, we have incurred significant losses in each period and on an aggregate basis. We have not yet commercialized any product candidates, and we do not expect to generate revenue from sales of any product candidates for the foreseeable future, if at all. As of June 30, 2025, we had $313.4 million in cash, cash equivalents, and marketable securities and we had an accumulated deficit of $287.3 million. From inception through June 30, 2025, we have raised aggregate gross proceeds of approximately $559.2 million through the sale and issuance of our common stock, redeemable convertible preferred stock and convertible promissory notes.

Current wording

Since our inception, we have incurred significant losses in each period and on an aggregate basis. We have not yet commercialized any product candidates, and we do not expect to generate revenue from sales of any product candidates for the foreseeable future, if at all. As of September 30, 2025, we had $295.9 million in cash, cash equivalents, and marketable securities and we had an accumulated deficit of $307.5 million. From inception through September 30, 2025, we have raised aggregate gross proceeds of approximately $559.2 million through the sale and issuance of our common stock, redeemable convertible preferred stock and convertible promissory notes.

Previous wording

In May 2022, we entered into the Loan Agreement with SVB Innovative Credit Growth Fund IX, LP and Innovative Credit Growth Fund VIII-A, LP pursuant to which we were able to borrow up to an aggregate of $25.0 million across two potential tranches until December 31, 2023. The Loan Agreement has a floating interest rate of the higher of the Wall Street Journal Prime rate plus 4.00% or 7.5%. The amounts borrowed under the Loan Agreement are scheduled to mature on April 1, 2026 and beginning November 1, 2023 we started making monthly principal payments. In addition, we will also be required to pay a final payment fee equal to 4.4% of the total amount borrowed. As of June 30, 2025, we had $5.0 million outstanding under the Loan Agreement. See Note 5 to our unaudited condensed consolidated financial statements included elsewhere in this Quarterly Report for further discussion of the Loan Agreement.

Current wording

In May 2022, we entered into the Loan Agreement with SVB Innovative Credit Growth Fund IX, LP and Innovative Credit Growth Fund VIII-A, LP pursuant to which we were able to borrow up to an aggregate of $25.0 million across two potential tranches until December 31, 2023. The Loan Agreement has a floating interest rate of the higher of the Wall Street Journal Prime rate plus 4.00% or 7.5%. The amounts borrowed under the Loan Agreement are scheduled to mature on April 1, 2026 and beginning November 1, 2023 we started making monthly principal payments. In addition, we will also be required to pay a final payment fee equal to 4.4% of the total amount borrowed. As of September 30, 2025, we had $3.5 million outstanding under the Loan Agreement. See Note 5 to our unaudited condensed consolidated financial statements included elsewhere in this Quarterly Report for further discussion of the Loan Agreement.

Previous wording

Cash used in operating activities during the six months ended June 30, 2025 was $37.3 million, and was primarily due to our net loss of $34.5 million and a $9.3 million change in operating assets and liabilities. These changes were partially offset by non-cash adjustments of $6.5 million, of which $6.2 million related to stock-based compensation expense.

Current wording

Cash used in operating activities during the nine months ended September 30, 2025 was $53.4 million, and was primarily due to our net loss of $54.7 million and a $8.1 million change in operating assets and liabilities. These changes were partially offset by non-cash adjustments of $9.4 million, of which $9.0 million related to stock-based compensation expense.

Previous wording

Cash used in operating activities during the six months ended June 30, 2024 was $31.5 million, and was primarily due to our net loss of $26.6 million and a $8.6 million change in operating assets and liabilities. These changes were partially offset by non-cash adjustments of $3.7 million, of which $2.4 million related to stock-based compensation expense.

Current wording

Cash used in operating activities during the nine months ended September 30, 2024 was $46.4 million, and was primarily due to our net loss of $50.0 million and a $2.4 million change in operating assets and liabilities. These changes were partially offset by non-cash adjustments of $6.0 million, of which $4.3 million related to stock-based compensation expense.

Previous wording

Cash used in investing activities was $93.6 million during the six months ended June 30, 2025 and included cash outflows of $101.5 million related to the purchase of marketable securities as well as $0.6 million related to the purchase of property and equipment. These changes were partially offset by maturities of marketable securities of $8.5 million.

Current wording

Cash used in investing activities was $80.8 million during the nine months ended September 30, 2025 and included cash outflows of $114.4 million related to the purchase of marketable securities as well as $0.6 million related to the purchase of property and equipment. These changes were partially offset by maturities of marketable securities of $34.3 million.

Previous wording

There was less than $0.1 million used for investing activities during the six months ended June 30, 2024, all of which related to the purchase of property and equipment.

Current wording

There was $0.3 million used for investing activities during the nine months ended September 30, 2024, all of which related to the purchase of property and equipment.

Previous wording

Cash used in financing activities during the six months ended June 30, 2025 was $3.0 million due to principal payments on our Term Loan.

Current wording

Cash used in financing activities during the nine months ended September 30, 2025 was $4.5 million due to principal payments on our Term Loan and cash paid for deferred offering costs.

Previous wording

Cash provided by financing activities during the six months ended June 30, 2024 was $165.6 million, resulting from the issuance and sale of our Series D Redeemable Convertible Preferred Stock for $169.5 million in net proceeds and $0.4 million in proceeds from stock option exercises, partially offset by $3.0 million in principal payments on our Term Loan and $1.3 million in deferred offering costs related to our initial public offering.

Current wording

Cash provided by financing activities during the nine months ended September 30, 2024 was $356.3 million, resulting from $180.9 million in net proceeds from our IPO, $9.8 million in net proceeds from the sale of our common stock through a private placement transaction, $169.5 million in net proceeds from the issuance and sale of our Series D redeemable convertible preferred stock and $0.6 million in proceeds from stock option exercises. These changes were partially offset by $4.5 million in principal payments on our Term Loan.

Previous wording

A change in the outcome of any of these or other variables with respect to the development of BGE-102 or any product or development candidate we may develop in the future could significantly change the costs and timing associated with our development plans. Further, our operating plans may change in the future, and we may need additional funds to meet operational needs and capital requirements associated with such operating plans.

Current wording

A change in the outcome of any of these or other variables with respect to the development of our lead product candidate, BGE-102, or any product or development candidate we may develop in the future could significantly change the costs and timing associated with our development plans. Further, our operating plans may change in the future, and we may need additional funds to meet operational needs and capital requirements associated with such operating plans.

Previous wording

We lease office and lab space in Emeryville, California (the Emeryville Lease). The Emeryville Lease is accounted for as an operating lease and expires on February 24, 2031. As of June 30, 2025, our non-cancellable base rent lease obligations related to the Emeryville Lease were $4.3 million, of which $0.6 million is due within the next 12 months.

Current wording

We lease office and lab space in Emeryville, California (the Emeryville Lease). The Emeryville Lease is accounted for as an operating lease and expires on February 24, 2031. As of September 30, 2025, our non-cancellable base rent lease obligations related to the Emeryville Lease were $4.1 million, of which $0.6 million is due within the next 12 months.

Previous wording

Our critical accounting policies and estimates are described in “Management’s Discussion and Analysis of Financial Condition and Results of Operations - Critical Accounting Policies and Estimates” in our audited financial statements and the notes thereto for the year ended December 31, 2024 included in Form 10-K filed with the Securities and Exchange Commission on March 20, 2025. There were no material changes to these accounting policies during the six months ended June 30, 2025, except for the new critical accounting policy noted below.

Current wording

Our critical accounting policies and estimates are described in “Management’s Discussion and Analysis of Financial Condition and Results of Operations - Critical Accounting Policies and Estimates” in our audited financial statements and the notes thereto for the year ended December 31, 2024 included in Form 10-K filed with the Securities and Exchange Commission on March 20, 2025. There were no material changes to these accounting policies during the nine months ended September 30, 2025, except for the new critical accounting policy noted below.

Previous wording

Under Section 107(b) of the JOBS Act an “emerging growth company” can delay the adoption of new or revised accounting standards until such time as those standards would apply to private companies. We have elected this exemption to delay adopting new or revised accounting standards until such time as those standards apply to private companies. Where allowable we have early adopted certain standards as described in Note 2 of our unaudited condensed consolidated financial statements included elsewhere in this Quarterly Report As a result, our unaudited condensed consolidated financial statements may not be comparable to companies that comply with the new or revised accounting pronouncements as of public company effective dates. We will continue to remain an “emerging growth company” until the earliest of the following: (i) the last day of the fiscal year following the fifth anniversary of the date of the completion of our IPO; (ii) the last day of the fiscal year in which our total annual gross revenue is equal to or more than $1.235 billion; (iii) the date on which we have issued more than $1.0 billion in nonconvertible debt during the previous three years; or (iv) the date on which we are deemed to be a large accelerated filer under the rules of the SEC.

Current wording

Quarterly Report As a result, our unaudited condensed consolidated financial statements may not be comparable to companies that comply with the new or revised accounting pronouncements as of public company effective dates. We will continue to remain an “emerging growth company” until the earliest of the following: (i) the last day of the fiscal year following the fifth anniversary of the date of the completion of our IPO; (ii) the last day of the fiscal year in which our total annual gross revenue is equal to or more than $1.235 billion; (iii) the date on which we have issued more than $1.0 billion in nonconvertible debt during the previous three years; or (iv) the date on which we are deemed to be a large accelerated filer under the rules of the SEC.
Rearranged current paragraphs (2)

Current report — wording carried from elsewhere

Further contributing to the increase in research and development expenses was a $1.4 million increase in personnel-related expenses, driven by stock-based compensation grants to employees and severance payments to certain former employees, and a $1.2 million increase in allocated facility and other expenses primarily related to facility expenses for our Emeryville Lease (defined below) and an increase in non-program specific consulting fees. These higher costs were partially offset by a $17.5 million reduction in azelaprag direct costs as development was terminated in January 2025.

Current report — wording carried from elsewhere

Under Section 107(b) of the JOBS Act an “emerging growth company” can delay the adoption of new or revised accounting standards until such time as those standards would apply to private companies. We have elected this exemption to delay adopting new or revised accounting standards until such time as those standards apply to private companies. Where allowable we have early adopted certain standards as described in Note 2 of our unaudited condensed consolidated financial statements included elsewhere in this
Rearranged previous paragraphs (1)

Previous report — wording carried elsewhere

We lease office and lab space in Richmond, California. The Richmond Lease is accounted for as an operating lease and expires on August 31, 2025. As of June 30, 2025, our non-cancellable base rent lease obligations related to the Richmond Lease were less than $0.1 million, all of which is due within the next 12 months.