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What changed in BioAge Labs, Inc.'s 10-K — 2024 vs 2025

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Paragraph-level year-over-year comparison of BioAge Labs, Inc.'s 2024 and 2025 10-K annual filings, covering the Business, Risk Factors, Legal Proceedings, Cybersecurity, MD&A and Market Risk sections. Every new, removed and edited paragraph is highlighted side-by-side so you can see exactly what management changed in the 2025 report.

+164 added−405 removedSource: 10-K (2026-03-24) vs 10-K (2025-03-20)

Top changes in BioAge Labs, Inc.'s 2025 10-K

164 paragraphs added · 405 removed · 115 edited across 1 sections

Item 1C. Cybersecurity

Cybersecurity — threats and controls disclosure

115 edited+49 added−290 removed80 unchanged
Biggest changeAs of December 31, 2024 and December 31, 2023, we have recorded a full valuation allowance against our deferred tax assets. 99 Results of Operations Comparison of the Years Ended December 31, 2024 and 2023 The following table summarizes our results of operations for each of the periods presented (in thousands, except percentages): Years Ended December 31, 2024 2023 $ Change % Change (unaudited) Operating expenses: Research and development $ 59,036 $ 33,886 $ 25,150 74 % General and administrative 19,158 14,514 4,644 32 % Total operating expenses 78,194 48,400 29,794 62 % Loss from operations $ (78,194 ) $ (48,400 ) $ (29,794 ) 62 % Other income (expense), net: Interest expense (2,367 ) (7,794 ) 5,427 (70 )% Interest and other income (expense), net 9,629 2,431 7,198 296 % Change in fair value of derivative liability and warrants 73 (10,091 ) 10,164 (101 )% Loss on extinguishment of convertible promissory notes (250 ) — (250 ) (100 )% Total other income (expense), net 7,085 (15,454 ) 22,539 (146 )% Net loss $ (71,109 ) $ (63,854 ) $ (7,255 ) 11 % Research and Development Expenses The following table summarizes our research and development expenses for each of the periods presented (in thousands, except percentages): Years Ended December 31, 2024 2023 $ Change % Change (unaudited) Direct costs: azelaprag $ 29,265 $ 6,443 $ 22,822 354 % Other programs 7,867 9,450 (1,583 ) (17 )% Indirect costs: Personnel-related expenses (including stock-based compensation expense) 16,204 13,726 2,478 18 % Allocated facility and other expenses 5,700 4,267 1,433 34 % Total research and development expenses $ 59,036 $ 33,886 $ 25,150 74 % Research and development expenses increased by $25.1 million from $33.9 million for the year ended December 31, 2023 to $59.0 million for the year ended December 31, 2024.
Biggest changeResearch and Development Expenses The following table summarizes our research and development expenses for each of the periods presented (in thousands, except percentages): Years Ended December 31, 2025 2024 $ Change % Change Direct costs: azelaprag $ 2,826 $ 29,265 $ (26,439 ) (90 )% BGE-102 17,131 $ 2,724 14,407 529 % Other programs 29,492 5,143 24,349 473 % Indirect costs: Personnel-related expenses (including stock-based compensation expense) 17,398 16,204 1,194 7 % Allocated facility and other expenses 7,119 5,700 1,419 25 % Total research and development expenses $ 73,966 $ 59,036 $ 14,930 25 % 116 Research and development expenses increased by $14.9 million from $59.0 million for the year ended December 31, 2024 to approximately $73.9 million for the year ended December 31, 2025.
Other significant general and administrative expenses include legal fees relating to patent, intellectual property and corporate matters, and fees paid for accounting, consulting and other professional services, and allocated expenses for rent, insurance and other operating costs.
Other significant general and administrative expenses include legal fees relating to patent, intellectual property and corporate matters, and fees paid for accounting, consulting and other professional services, allocated expenses for rent, insurance and other operating costs.
Also contributing to net cash used in operating activities for the year ended December 31, 2024 was a a $3.3 million decrease in deferred grant income, partially offset by a $12.5 million increase in deferred revenue related to the Novartis Agreement.
Also contributing to net cash used in operating activities for the year ended December 31, 2024 was a $3.3 million decrease in deferred grant income, partially offset by a $12.5 million increase in deferred revenue related to the Novartis Agreement.
Net Cash Provided by Financing Activities Net cash provided by financing activities during the year ended December 31, 2024 was $381.2 million, resulting from $207.2 million in net proceeds from our IPO, $9.9 million in net proceeds from the sale of our common stock through private 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 partially offset by $6.0 million in principal payments on our Term Loan.
Net cash provided by financing activities during the year ended December 31, 2024 was $381.2 million, resulting from $207.2 million in net proceeds from our IPO, $9.9 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 partially offset by $6.0 million in principal payments on our Term Loan.
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.
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.
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 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.
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.
Our future funding requirements will depend on, and could increase significantly as a result of, many factors, including: • the timing, cost and progress of preclinical and clinical development activities; • the cost of regulatory submissions and timing of regulatory approvals; • the number and scope of preclinical and clinical programs we decide to pursue; • the progress of the development efforts of parties with whom we may in the future enter into licenses, collaborations or other strategic partnerships; • the cash requirements of any future acquisitions or discovery of product candidates; 102 • our ability to establish and maintain licenses, collaborations or other strategic partnerships with third parties on favorable terms, if at all; • the costs involved in prosecuting and enforcing patent and other intellectual property claims; • the costs of manufacturing our product candidates by third parties; • the cost of commercialization activities of any future product candidates are approved for sale, including marketing, sales and distribution costs; • our efforts to enhance operational systems and hire additional personnel, including personnel to support development of our product candidates; and • our need to implement additional internal systems and infrastructure, including financial and reporting systems to satisfy our obligations as a public company.
Our future funding requirements will depend on, and could increase significantly as a result of, many factors, including: • the timing, cost and progress of preclinical and clinical development activities; • the cost of regulatory submissions and timing of regulatory approvals; • the number and scope of preclinical and clinical programs we decide to pursue; • the progress of the development efforts of parties with whom we may in the future enter into licenses, collaborations or other strategic partnerships; • the cash requirements of any future acquisitions or discovery of product candidates; • our ability to establish and maintain licenses, collaborations or other strategic partnerships with third parties on favorable terms, if at all; • the costs involved in prosecuting and enforcing patent and other intellectual property claims; • the costs of manufacturing our product candidates by third parties; • the cost of commercialization activities of any future product candidates are approved for sale, including marketing, sales and distribution costs; • our efforts to enhance operational systems and hire additional personnel, including personnel to support development of our product candidates; and • our need to implement additional internal systems and infrastructure, including financial and reporting systems to satisfy our obligations as a public company.
As we do not have sufficient historical information to develop reasonable expectations about future exercise patterns and post-vesting employment termination behavior, the expected term of options granted 104 is derived from the average midpoint between the weighted average vesting and the contractual term, also known as the simplified method. • Expected Volatility—Since we do not have sufficient history to estimate the expected volatility of our common stock price, expected volatility is estimated based on the average historical volatility of similar entities with publicly traded shares.
As we do not have sufficient historical information to develop reasonable expectations about future exercise patterns and post-vesting employment termination behavior, the expected term of options granted is derived from the average midpoint between the weighted average vesting and the contractual term, also known as the simplified method. • Expected Volatility—Since we do not have sufficient history to estimate the expected volatility of our common stock price, expected volatility is estimated based on the average historical volatility of similar entities with publicly traded shares.
We base our expenses related to research and development activities on our estimates of the services received and efforts expended pursuant to quotes and contracts with vendors that conduct research and development activities on our behalf. The financial terms of these agreements are subject to negotiation, vary from contract to contract and may result in uneven payment flows.
We base our expenses related to research and development activities on our estimates of the services received and efforts expended pursuant to quotes and contracts with vendors that conduct research and development activities on our behalf. The financial terms of these agreements are subject to negotiation, vary from contract to contract and may result in uneven payment 120 flows.
Several information systems, such as software applications and cloud platforms, are provided by third parties. Our cybersecurity risk framework is designed to allow us to identify, assess and manage the cybersecurity risks we face in relation to, our systems and the information we process. As part of our framework, we maintain certain processes defined to assess, identify and manage risks.
Several information systems, such as software applications and cloud platforms, are provided by third parties. Our cybersecurity risk framework is designed to allow us to identify, assess and manage the cybersecurity risks we face in relation to our systems and the information we process. As part of our framework, we maintain certain processes designed to assess, identify and manage risks.
The Rule 10b5-1 plans listed above each included a representation from the director or officer to the broker administering the plan that they were not in possession of any material nonpublic information regarding the Company or the securities subject to the plan.
The Rule 10b5-1 plan listed above each included a representation from the director or officer to the broker administering the plan that they were not in possession of any material nonpublic information regarding the Company or the securities subject to the plan.
INDEX TO CONSOLIDATED FINANCIAL STATEMENTS Report of Independent Registered Public Accounting Firm F- 1 Consolidated Balance Sheets as of December 31, 2024 and 2023 F- 2 Consolidated Statements of Operations and Comprehensive Loss for the Years ended December 31, 2024 and 2023 F- 3 Consolidated Statements of Redeemable Convertible Preferred Stock and Stockholders’ Equity (Deficit) for the Years ended December 31, 2024 and 2023 F- 4 Consolidated Statements of Cash Flows for the Years ended December 31, 2024 and 2023 F- 5 Notes to Consolidated Financial Statements F- 6 (a)(2) Financial Statement Schedules All financial statement schedules have been omitted because they are not applicable, not required or the information required is shown in the financial statements or the notes thereto.
INDEX TO CONSOLIDATED FINANCIAL STATEMENTS Report of Independent Registered Public Accounting Firm F- 1 Consolidated Balance Sheets as of December 31, 2025 and 2024 F- 2 Consolidated Statements of Operations and Comprehensive Loss for the Years ended December 31, 2025 and 2024 F- 3 Consolidated Statements of Redeemable Convertible Preferred Stock and Stockholders’ Equity (Deficit) for the Years ended December 31, 2025 and 2024 F- 4 Consolidated Statements of Cash Flows for the Years ended December 31, 2025 and 2024 F- 5 Notes to Consolidated Financial Statements F- 6 (a)(2) Financial Statement Schedules All financial statement schedules have been omitted because they are not applicable, not required or the information required is shown in the financial statements or the notes thereto.
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 107 Report on Form 10-K and, similar to emerging growth companies, smaller reporting companies have reduced disclosure obligations regarding executive compensation. Ite m 7A. Quantitative and Qualitative Disclosures About Market Risk.
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 on Form 10-K and, similar to emerging growth companies, smaller reporting companies have reduced disclosure obligations regarding executive compensation. 123 Ite m 7A. Quantitative and Qualitative Disclosures About Market Risk.
The information required by this item will be included in our 2025 Proxy Statement to be filed with the SEC within 120 days of the end of our fiscal year covered by this Annual Report on Form 10-K and is incorporated herein by reference. It em 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters.
The information required by this item will be included in our 2026 Proxy Statement to be filed with the SEC within 120 days of the end of our fiscal year covered by this Annual Report on Form 10-K and is incorporated herein by reference. It em 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters.
(a)(3) Exhibits The following is a list of exhibits filed, furnished or incorporated by reference as part of this Annual Report on Form 10-K. 112 Exhibit Index Exhibit Number Description Form File No. Exhibit Filing Date Filed Herewith 3.1 Restated Certificate of Incorporation. 10-Q 001-42279 3.1 11/07/2024 3.2 Restated Bylaws. 10-Q 001-42279 3.2 11/07/2024 4.1 Form of Common Stock Certificate.
(a)(3) Exhibits The following is a list of exhibits filed, furnished or incorporated by reference as part of this Annual Report on Form 10-K. 127 Exhibit Index Exhibit Number Description Form File No. Exhibit Filing Date Filed Herewith 3.1 Restated Certificate of Incorporation. 10-Q 001-42279 3.1 11/07/2024 3.2 Restated Bylaws. 10-Q 001-42279 3.2 11/07/2024 4.1 Form of Common Stock Certificate.
The information required by this item will be included in our 2025 Proxy Statement to be filed with the SEC within 120 days of the end of our fiscal year covered by this Annual Report on Form 10-K and is incorporated herein by reference. It em 13. Certain Relationships and Related Transactions, and Director Independence.
The information required by this item will be included in our 2026 Proxy Statement to be filed with the SEC within 120 days of the end of our fiscal year covered by this Annual Report on Form 10-K and is incorporated herein by reference. It em 13. Certain Relationships and Related Transactions, and Director Independence.
The information required by this item will be included in our 2025 Proxy Statement to be filed with the SEC within 120 days of the end of our fiscal year covered by this Annual Report on Form 10-K and is incorporated herein by reference. Ite m 14. Principal Accounting Fees and Services.
The information required by this item will be included in our 2026 Proxy Statement to be filed with the SEC within 120 days of the end of our fiscal year covered by this Annual Report on Form 10-K and is incorporated herein by reference. Ite m 14. Principal Accounting Fees and Services.
The terms of these agreements typically contain multiple promises or obligations, which may include: (1) licenses, or options to obtain licenses, to use the Company’s technology, (2) research and development activities to be performed on behalf of the collaboration partner, and (3) in certain cases, services in connection with the manufacturing of preclinical and clinical material.
The terms of these agreements typically contain multiple promises or obligations, which may include: (1) licenses, or options to obtain licenses, to use our technology, (2) research and development activities to be performed on behalf of the collaboration partner, and (3) in certain cases, services in connection with the manufacturing of preclinical and clinical material.
The remaining information required by this item will be included in our 2025 Proxy Statement to be filed with the SEC within 120 days of the end of our fiscal year covered by this Annual Report on Form 10-K and is incorporated herein by reference. It em 11. Executive Compensation.
The remaining information required by this item will be included in our 2026 Proxy Statement to be filed with the SEC within 120 days of the end of our fiscal year covered by this Annual Report on Form 10-K and is incorporated herein by reference. It em 11. Executive Compensation.
Concurrently with the initial public offer, we also completed a private placement, in which we issued and sold an aggregate of 588,888 shares of our common stock at a price of $18.00 per share to Sofinnova Venture Partners, IX, L.P.
Concurrently with the initial public offer, we also completed a private placement, in which we issued and sold an aggregate of 588,888 shares of our common stock at a price of $18.00 per share to Sofinnova Venture Partners, XI, L.P.
Certain information required by this item will be included in our definitive proxy statement ("2025 Proxy Statement") to be filed with the SEC within 120 days of the end of our fiscal year covered by this Annual Report on Form 10-K and is incorporated herein by reference.
Certain information required by this item will be included in our definitive proxy statement ("2026 Proxy Statement") to be filed with the SEC within 120 days of the end of our fiscal year covered by this Annual Report on Form 10-K and is incorporated herein by reference.
Amounts not expected to be recognized as revenue within the 12 months following the balance sheet date are classified as noncurrent deferred revenue. Amounts recognized as revenue, but not yet invoiced are generally recognized as contract assets in the other current assets line item in the accompanying balance sheets.
Amounts not expected to be recognized as revenue within the 12 months following the balance sheet date are classified as noncurrent deferred revenue. Amounts recognized as revenue, but not yet invoiced are generally recognized as contract assets in the other current assets line item in our balance sheets.
Adequate additional funds may not be available to us on acceptable terms, or at all.
Adequate additional funds may not be 119 available to us on acceptable terms, or at all.
Invoices issued as stipulated in contracts prior to revenue recognition are recorded as deferred revenue. Amounts expected to be recognized as revenue within the 12 months following the balance sheet date are classified as deferred revenue within current liabilities in the accompanying balance sheets.
Invoices issued as stipulated in contracts prior to revenue recognition are recorded as deferred revenue. Amounts expected to be recognized as revenue within the 12 months following the balance sheet date are classified as deferred revenue within current liabilities in our balance sheets.
(a)(1) Financial Statements The following documents are included on pages F-1 through F-24 attached hereto and are filed as part of this Annual Report on Form 10-K.
(a)(1) Financial Statements The following documents are included on pages F-1 through F- 25 attached hereto and are filed as part of this Annual Report on Form 10-K.
Based on that evaluation, our Principal Executive Officer and Principal Financial Officer concluded that our disclosure controls and procedures were effective at the reasonable assurance level as of December 31, 2024.
Based on that evaluation, our Principal Executive Officer and Principal Financial Officer concluded that our disclosure controls and procedures were effective at the reasonable assurance level as of December 31, 2025.
Other (Income) Expense, Net Interest Expense Interest expense consists of interest incurred on both our convertible promissory notes and term loan. Interest and Other Income (Expense), Net Interest and other income (expense), net primarily consist of interest income generated from interest bearing cash and cash equivalents.
Other Income (Expense), Net Interest Expense Interest expense consists of interest incurred on both our convertible promissory notes and term loan. Interest and Other Income (Expense), Net Interest and other income (expense), net primarily consist of interest income generated from interest bearing cash, cash equivalents and marketable securities.
In addition, we will also be required to pay a final payment fee equal to 4.4% of the total amount borrowed. As of December 31, 2024, we had $8.0 million outstanding under the Loan Agreement. See Note 5 to our consolidated financial statements included elsewhere in this Annual Report for further discussion of the Loan Agreement.
In addition, we will also be required to pay a final payment fee equal to 4.4% of the total amount borrowed. As of December 31, 2025, we had $2.0 million outstanding under the Loan Agreement. See Note 5 to our consolidated financial statements included elsewhere in this Annual Report for further discussion of the Loan Agreement.
The information required by this item will be included in our 2025 Proxy Statement to be filed with the SEC within 120 days of the end of our fiscal year covered by this Annual Report on Form 10-K and is incorporated herein by reference. 111 PART IV It em 15. Exhibits, Financial Statement Schedules.
The information required by this item will be included in our 2026 Proxy Statement to be filed with the SEC within 120 days of the end of our fiscal year covered by this Annual Report on Form 10-K and is incorporated herein by reference. 126 PART IV It em 15. Exhibits, Financial Statement Schedules.
Please also see the section titled “Special Note Regarding Forward-Looking Statements.” Overview 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.
Please also see the section titled “Special Note Regarding Forward-Looking Statements.” Overview We are a clinical-stage biopharmaceutical company developing therapeutic product candidates for metabolic diseases 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.
Arrangements that include rights to additional goods or services that are exercisable at a customer’s discretion are generally considered options. The Company assesses if these options provide a material right to the customer and if so, these options are considered performance obligations. The exercise of a material right is accounted for as a contract modification for accounting purposes.
Arrangements that include rights to additional goods or services that are exercisable at a customer’s discretion are generally considered options. We assess if these options provide a material right to the customer and, if so, these options are considered performance obligations. The exercise of a material right is accounted for as a contract modification for accounting purposes.
Deferred revenue related to the Novartis Agreement amounted to $12.5 million as of December 31, 2024, of which $7.8 million was included in current liabilities within the consolidated balance sheets.
Deferred revenue related to the Novartis Agreement amounted to $5.8 million and $12.5 million as of December 31, 2025, and December 31, 2024, respectively, of which $5.8 million and $7.8 million, respectively, was included in current liabilities within the consolidated balance sheets.
Goods or services that meet these criteria are considered distinct performance obligations. If both these criteria are not met, the goods and services are combined into a single performance obligation. The Company then recognizes as revenue the amount of the transaction price that is allocated to the respective performance obligation when (or as) the performance obligation is satisfied.
Goods or services that meet these criteria are considered distinct performance obligations. If both these criteria are not met, the goods and services are combined into a single performance obligation. We then recognize as revenue the amount of the transaction price that is allocated to the respective performance obligation when (or as) the performance obligation is satisfied.
See Note 7 of our audited consolidated financial statements included elsewhere in this Annual Report for information concerning certain of the specific assumptions we used in applying the Black-Scholes option pricing model to determine the estimated fair value of our stock options granted in the twelve months ended December 31, 2024 and 2023.
See Note 7 to our audited consolidated financial statements included elsewhere in this Annual Report for information concerning certain of the specific assumptions we used in applying the Black-Scholes option pricing model to determine the estimated fair value of our stock options granted in the years ended December 31, 2025 and 2024.
The Company recognizes as revenue the amount of the transaction price that is allocated to the respective performance obligation when (or as) each performance obligation is satisfied at a point in time or over time, and if over time this is based on the use of an output or input method.
We recognize as revenue the amount of the transaction price that is allocated to the respective performance obligation when (or as) each performance obligation is satisfied at a point in time or over time, and if over time this is based on the use of an output or input method.
For elements of collaboration arrangements that are accounted for pursuant to ASC 808, an appropriate recognition method is determined and applied consistently, generally by analogy to ASC 606. For those elements of the arrangement that are accounted for pursuant to ASC 606, the Company applies the five-step model described above.
For elements of collaboration arrangements that are accounted for pursuant to ASC 808, an appropriate recognition method is determined and applied consistently, generally by analogy to ASC 606. For those elements of the arrangement that are accounted for pursuant to ASC 606, we apply the five-step model described above.
X 101.SCH Inline XBRL Taxonomy Extension Schema With Embedded Linkbase Documents X 104 Cover Page Interactive Data File (formatted in Inline XBRL and contained in Exhibit 101) X * This certification is deemed not filed for purposes of Section 18 of the Exchange Act or otherwise subject to the liability of that section, nor shall it be deemed incorporated by reference into any filing under the Securities Act or the Exchange Act.
X 101.SCH Inline XBRL Taxonomy Extension Schema With Embedded Linkbase Documents X 104 Cover Page Interactive Data File (formatted in Inline XBRL and contained in Exhibit 101) X ^ Indicates a management contract or compensatory plan, contract or arrangement. * This certification is deemed not filed for purposes of Section 18 of the Exchange Act or otherwise subject to the liability of that section, nor shall it be deemed incorporated by reference into any filing under the Securities Act or the Exchange Act.
Food and Drug Administration, 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.
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 114 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.
For collaboration arrangements within the scope of ASC 808 that contain multiple elements, the Company first determines which elements of the collaboration are deemed to be within the scope of ASC 808 and those that are more reflective of a vendor-customer relationship and, therefore, are within the scope of ASC 606.
For collaboration arrangements within the scope of ASC 808 that contain multiple elements, we first determine which elements of the collaboration are deemed to be within the scope of ASC 808 and those that are more reflective of a vendor-customer relationship and, therefore, are within the scope of ASC 606.
We recognize direct development costs based on an evaluation of the progress to completion of specific tasks using information provided to us by our vendors or our estimate of the level of service that has been performed at each reporting date.
We expense research and development costs as incurred. We recognize direct development costs based on an evaluation of the progress to completion of specific tasks using information provided to us by our vendors or our estimate of the level of service that has been performed at each reporting date.
Non-cancellable base rent lease obligations as of December 31, 2024 were $4.4 million of which $0.5 million is due within the next 12 months. Purchase and Other Obligations We enter into contracts in the normal course of business with CROs, CDMOs and other third-party vendors for preclinical research studies and testing, clinical trials and testing and manufacturing services.
Non-cancellable base rent lease obligations as of December 31, 2025 were $3.9 million, of which $0.6 million is due within the next 12 months. Purchase and Other Obligations We enter into contracts in the normal course of business with CROs, CDMOs and other third-party vendors for preclinical research studies and testing, clinical trials and testing and manufacturing services.
Not applicable. 110 PART III It em 10. Directors, Executive Officers and Corporate Governance.
Not applicable. 125 PART III It em 10. Directors, Executive Officers and Corporate Governance.
At contract inception, once the contract is determined to be within the scope of ASC 606, the Company evaluates the performance obligations promised in the contract that are based on goods and services that will be transferred to the customer and determines whether those obligations are both (i) capable of being distinct and (ii) distinct in the context of the contract.
At contract inception, once the contract is determined to be within the scope of ASC 606, we evaluate the performance obligations promised in the contract that are based on goods and services that will be transferred to the customer and determine whether those obligations are both (i) capable of being distinct and (ii) distinct in the context of the contract.
F- 10 Royalties – For arrangements that include sales-based royalties, including milestone payments based on a level of sales, which are the result of a customer-vendor relationship and for which the license is deemed to be the predominant item to which the royalties relate, the Company recognizes revenue at the later of (i) when the related sales occur, or (ii) when the performance obligation linked to some or all of the royalty has been satisfied or partially satisfied.
Royalties – For arrangements that include sales-based royalties, including milestone payments based on a level of sales, which are the result of a customer-vendor relationship and for which the license is deemed to be the predominant item to which the royalties relate, we recognize revenue at the later of (i) when the related sales occur, or (ii) when the performance obligation to which some or all of the royalty has been allocated has been satisfied or partially satisfied.
We may never obtain regulatory approval for any product candidates that we develop. The successful development of any product candidates we may develop in the future is highly uncertain.
We may never obtain regulatory approval for any product candidates that we develop. The successful development of BGE-102 or any other product candidates we may develop in the future is highly uncertain.
Milestone Payments – If an arrangement includes development and regulatory milestone payments, the Company evaluates whether the milestones are considered probable of being reached and estimates the amount to be included in the transaction price using the most likely amount method.
Milestone Payments – If an arrangement includes development and regulatory milestone payments, we evaluate whether the milestones are considered probable of being reached and estimate the amount to be included in the transaction price using the most likely amount method.
In consideration for the rights granted under the Novartis Agreement, the Company will receive upfront payments and research funding of up to $ 20.0 million and up to $ 530.0 million in future long-term research, development, and commercial milestones.
In consideration for the rights granted under the Novartis Agreement, we have received and may receive upfront payments and research funding of up to $20.0 million, and up to $530.0 million in future long-term research, development, and commercial milestones.
We recorded stock-based compensation expense of $7.0 million and $3.0 million for the years ended December 31, 2024 and 2023, respectively. As of December 31, 2024, there was $26.4 million of unrecognized stock-based compensation expense related to unvested stock options, to be recognized over a weighted-average period of 2.8 years.
We recorded stock-based compensation expense of $11.7 million and $7.0 million for the years ended December 31, 2025 and 2024, respectively. As of December 31, 2025, there was $23.8 million of unrecognized stock-based compensation expense related to unvested stock options, to be recognized over a weighted-average period of 2.5 years.
On November 22, 2024 , Shane Barton , C.P.A., the Company’s Principal Accounting Officer , adopted a Rule 10b5-1 trading plan. Mr. Barton's Rule 10b5-1 trading plan is intended to satisfy the affirmative defense conditions of Rule 10b5-1(c) and provides for the potential sale of up to 2,632 shares of the Company’s common stock held by Mr.
Other Information. 10b5-1 Plans On December 16, 2025 , Shane Barton , C.P.A., the Company’s Principal Accounting Officer, adopted a Rule 10b5-1 trading plan. Mr. Barton's Rule 10b5-1 trading plan is intended to satisfy the affirmative defense conditions of Rule 10b5-1(c) and provides for the potential sale of up to 2,632 shares of the Company’s common stock held by Mr.
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: • continue to progress the development of BGE-102; • discover and develop any future product candidates; • obtain, expand, maintain, defend and enforce our intellectual property portfolio; • manufacture, or have manufactured, preclinical, clinical and potentially commercial supplies of any future product candidates; • seek regulatory approvals for any future product candidates that successfully complete clinical trials, if any; • establish a sales, marketing and distribution infrastructure to commercialize BGE-102 or any future product candidates, if approved; • seek to identify, evaluate and establish licenses, collaborations or other strategic partnerships; • hire additional clinical, scientific and management personnel, as well as administrative staff to support the growth of our business; • add operational, financial and management information systems and personnel; and • incur additional legal, accounting and other costs associated with operating as a public company. 95 Our net losses may fluctuate significantly from period to period, depending on the timing of factors above.
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: • continue to progress the development of our lead product candidate, BGE-102; • explore additional indications for our existing product candidates; • discover and develop any future product candidates; • obtain, expand, maintain, defend and enforce our intellectual property portfolio; • manufacture, or have manufactured, preclinical, clinical and potentially commercial supplies of BGE-102 and any future product candidates; • seek regulatory approvals for BGE-102 or for any future product candidates that successfully complete clinical trials, if any; • establish a sales, marketing and distribution infrastructure to commercialize BGE-102 or any future product candidates, if approved; • seek to identify, evaluate and establish licenses, collaborations or other strategic partnerships; 111 • hire additional clinical, scientific and management personnel, as well as administrative staff to support the growth of our business; and • add operational, financial and management information systems and personnel.
There is no assurance that we will ever be profitable or generate positive cash flow from operating activities. Contractual Obligations and Other Commitments Lease Obligations We lease office and lab space at our corporate headquarters in Richmond, California (the Headquarters Lease). The Headquarters lease is accounted for as an operating lease and expires on August 31, 2025.
There is no assurance that we will ever be profitable or generate positive cash flow from operating activities. Contractual Obligations and Other Commitments Lease Obligations We lease office and lab space at our corporate headquarters in Emeryville, CA (the Emeryville Lease). The Emeryville lease is accounted for as an operating lease and expires on February 28, 2031.
As of December 31, 2024, we had $354.3 million in cash and cash equivalents. Based on our current operating plan, we estimate that our existing cash and cash equivalents as of the date of this Annual Report will be sufficient to fund our operations and capital expenses through 2029.
As of December 31, 2025, we had $285.1 million in cash, cash equivalents and marketable securities. Based on our current operating plan, we estimate that our existing cash, cash equivalents and marketable securities as of the filing date of this Annual Report will be sufficient to fund our operations and capital expenses through 2029.
As of December 31, 2024, we had U.S. federal and state net operating loss carryforwards of $104.4 million and $13.7 million, respectively, which expire at various dates beginning in 2035. These attributes may be subject to Section 382 limitation and we have not performed a formal assessment.
As of December 31, 2025, we had U.S. federal and state net operating loss carryforwards of $204.1 million and $15.9 million, respectively, which expire at various 115 dates beginning in 2035. These attributes may be subject to Section 382 limitation and we have not performed a formal assessment.
X 10.3 2024 Employee Stock Purchase Plan and forms of award agreements. S-1/A 333-281901 10.4 09/18/2024 10.4 Change in Control and Severance Plan. S-1/A 333-281901 10.5 09/18/2024 10.5 Offer Letter by and between the Registrant and Kristen Fortney, dated September 17, 2024.
S-1/A 333-281901 10.1 09/18/2024 10.2^ 2024 Equity Incentive Plan and forms of award agreements. 10-K 001-42279 10.2 03/20/2025 10.3^ 2024 Employee Stock Purchase Plan and forms of award agreements. S-1/A 333-281901 10.4 09/18/2024 10.4^ Change in Control and Severance Plan. S-1/A 333-281901 10.5 09/18/2024 10.5^ Offer Letter by and between the Registrant and Kristen Fortney, dated September 17, 2024.
Funding Requirements Our primary uses of capital are, and we expect will continue to be, research and development services, compensation and related expenses and general overhead costs. We expect to continue to incur significant expenses and operating losses for the foreseeable future. In addition, we expect to incur additional costs associated with operating as a public company.
Funding Requirements Our primary uses of capital are, and we expect will continue to be, research and development services, compensation and related expenses and general overhead costs. We expect to continue to incur significant expenses and operating losses for the foreseeable future.
We and Novartis each have the right to advance novel targets discovered under the Novartis Agreement and are each eligible to receive reciprocal success milestones and receive tiered royalties on net sales of licensed products. No revenue was recognized under the Novartis Agreement in the years ended December 31, 2024 or 2023.
We and Novartis each have the right to advance novel targets discovered under the Novartis Agreement and are each eligible to receive reciprocal success milestones and receive tiered royalties on net sales of licensed products. Collaboration revenue of $9.0 million was recognized under the Novartis Agreement in the year ended December 31, 2025.
Research and Development Expense 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 azelaprag and potential future product candidates, and include: Direct Costs: • expenses incurred under agreements with contract research organizations (CROs) that are primarily engaged in the oversight and conduct of our clinical trials; CDMOs that are primarily engaged to provide drug substance and product for our clinical trials and preclinical studies, research and development programs, as well as investigative sites and consultants that conduct our clinical trials, preclinical studies and other scientific development services; • the cost of acquiring and manufacturing preclinical and clinical trial materials, including manufacturing registration and validation batches; • costs of outside consultants, including their fees and related travel expenses; • costs related to compliance with quality and regulatory requirements; and • payments made under third-party licensing agreements.
Research and Development Expense 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: Direct Costs: • expenses incurred under agreements with CROs that are primarily engaged in the oversight and conduct of our clinical trials; CDMOs that are primarily engaged to provide drug substance and product for our clinical trials and preclinical studies, research and development programs, as well as investigative sites and consultants that conduct our clinical trials, preclinical studies and other scientific development services; • the cost of acquiring and manufacturing preclinical and clinical trial materials, including manufacturing registration and validation batches; • costs of outside consultants, including their fees and related travel expenses; • costs related to compliance with quality and regulatory requirements; and • payments made under third-party licensing agreements. 113 Indirect Costs: • personnel-related expenses including, salaries, bonuses, benefits, stock-based compensation expenses and other related costs for individuals involved in research and development activities; and • allocated facilities and other expenses not directly tied to a program.
Other Income (Expense), Net Other income (expense), net increased by approximately $22.6 million from $15.5 million of other expense for the year ended December 31, 2023 to $7.1 million of other income for the year ended December 31, 2024.
Other Income (Expense), Net Other income (expense), net increased by approximately $5.1 million from $7.1 million for the year ended December 31, 2024 to $12.2 million of other income for the year ended December 31, 2025.
S-1/A 333-281901 10.12 09/18/2024 10.8 Share Purchase Agreement, dated as of September 25, 2024, by and among Company and the Purchaser. 8-K 001-42279 10.1 09/27/2024 10.9 Office and Laboratory Lease by and between the Company and ES East, LLC, dated August 23, 2024. 10-Q 001-42279 10.9 11/07/2024 10.10 Loan and Security Agreement, dated May 20, 2022, by and among the Registrant, Silicon Valley Bank and the lenders thereunder.
S-1/A 333-281901 10.12 09/18/2024 10.8 Office and Laboratory Lease by and between the Company and ES East, LLC, dated August 23, 2024. 10-Q 001-42279 10.9 11/07/2024 10.9 Loan and Security Agreement, dated May 20, 2022, by and among the Registrant, Silicon Valley Bank and the lenders thereunder. 10-K 001-42279 10.10 03/20/2025 10.10 Sales Agreement, dated October 2, 2025, by and between the Company and Leerink Partners LLC.
For example, we have an incident management and response process under which we communicate the details of certain threats and incidents to management and the audit committee of the board of directors as may be appropriate; use manual and automated processes that are designed to monitor relevant information systems for vulnerabilities, threats and incidents; manage and take certain actions designed to address incidents that may occur; and take actions designed to remediate certain vulnerabilities identified in relevant environments.
For example, we maintain an incident management and response process under which significant cybersecurity threats and incidents are escalated to appropriate management and, where appropriate, reported to the Audit Committee; use manual and automated processes that are designed to monitor relevant information systems for vulnerabilities, threats and incidents; manage and take certain actions designed to address incidents that may occur; and take actions designed to remediate certain vulnerabilities identified in relevant environments.
We plan to expand this pipeline over time, both internally and through our target discovery collaboration with Novartis, and potentially through additional partnerships with pharmaceutical companies. 94 Our portfolio of product candidates and ongoing collaborations are summarized in the figure below: Since our inception in 2015, we have devoted substantially all of our efforts to organizing and staffing our company, business planning, raising capital, establishing our intellectual property portfolio, acquiring or discovering product candidates, research and development activities for our product candidates, establishing arrangements with third parties for the manufacture of our product candidates and component materials, and providing general and administrative support for these operations.
Our portfolio of product candidates and ongoing collaborations are summarized in the figure below: Since our inception in 2015, we have devoted substantially all of our efforts to organizing and staffing our company, business planning, raising capital, establishing our intellectual property portfolio, acquiring or discovering product candidates, research and development activities for our product candidates, establishing arrangements with third parties for the manufacture of our product candidates and component materials, and providing general and administrative support for these operations.
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 and political instability and military hostilities in multiple geographies, such as the conflicts in Ukraine, the Middle East and tensions between China and Taiwan.
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 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.
We anticipate that our expenses will increase significantly in connection with our ongoing activities. Based on our current operating plan, we estimate that our existing cash and cash equivalents as of the date of this Annual Report will be sufficient to fund our operations and capital expenses through 2029.
Based on our current operating plan, we estimate that our existing cash, cash equivalents and marketable securities as of the filing date of this Annual Report will be sufficient to fund our operations and capital expenses through 2029.
We employ an array of data security technologies, processes, and methods across our infrastructure designed to protect our systems and sensitive information from unauthorized access. We work with information technology consultants who provide advice and expertise on monitoring evolving industry practices. Our assessment and management of material risks from cybersecurity threats are integrated into the Company’s overall risk management processes.
We employ an array of data security technologies, processes, and methods across our infrastructure designed to help protect our systems and sensitive information from unauthorized access. We work with information technology consultants who provide advice and expertise on monitoring evolving industry practices.
Changes in internal control over financial reporting Except for the changes in internal control as referenced above for the remediation of previously reported material weaknesses, there have been no changes in our internal control over financial reporting (as defined in Rules 13a-15(f) and 15d-15(f) of the Exchange Act) during the year ended December 31, 2024 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
Changes in internal control over financial reporting There have been no changes in our internal control over financial reporting (as defined in Rules 13a-15(f) and 15d-15(f) of the Exchange Act) during the year ended December 31, 2025 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting. 124 It em 9B.
However, our indirect costs are not directly tied to any one program and are deployed across our programs. As such, we do not track these costs on a specific program basis. We utilize third party contractors for our research and development activities and CDMOs for our manufacturing activities and we do not have our own manufacturing facilities.
As such, we do not track these costs on a specific program basis. We utilize third party contractors for our research and development activities and CDMOs for our manufacturing activities and we do not have our own manufacturing facilities. Research and development activities are central to our business model.
Payments the Company receives under these arrangements typically include one or more of the following: non-refundable, upfront license fees; option exercise fees; funding of research and/or development efforts; clinical and development, regulatory, and sales milestone payments; and royalties on future product sales.
Payments we receive under these arrangements typically include one or more of the following: non-refundable, upfront license fees; option exercise fees; funding of research and/or development efforts; clinical and development, regulatory, and sales milestone payments; and royalties on future product sales. We classify payments received under these agreements as revenues within our statements of operations.
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 U.S.
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.
S-1 333-281901 4.1 09/03/2024 4.2 Amended and Restated Investors’ Rights Agreement, dated February 1, 2024, by and among the Registrant and certain of its stockholders. S-1 333-281901 4.4 09/03/2024 4.3 Description of Capital Stock X 10.1 Form of Indemnity Agreement. S-1/A 333-281901 10.1 09/18/2024 10.2 2024 Equity Incentive Plan and forms of award agreements.
S-1 333-281901 4.1 09/03/2024 4.2 Amended and Restated Investors’ Rights Agreement, dated February 1, 2024, by and among the Registrant and certain of its stockholders. S-1 333-281901 4.4 09/03/2024 4.3 Description of Capital Stock 10-K 001-42279 4.3 03/20/2025 10.1^ Form of Indemnity Agreement.
Holders of Common Stock As of March 17, 2025, there were approximately 102 holders of record of our common stock. This number does not include “street name” or beneficial holders, whose shares are held of record by banks, brokers, financial institutions and other nominees.
This number does not include “street name” or beneficial holders, whose shares are held of record by banks, brokers, financial institutions and other nominees.
Our Chief Financial Officer has over two decades of management experience, including oversight over information technology and cybersecurity matters. Our Board of Directors, with the assistance of the Audit Committee, has oversight for the cybersecurity risks facing us and for our processes designed to identify, prioritize, assess, manage, and mitigate those risks.
Our Board of Directors, with the assistance of the Audit Committee, has oversight for the cybersecurity risks facing us and for our processes designed to identify, prioritize, assess, manage, and mitigate those risks.
This is due to the numerous risks and uncertainties associated with product development. 98 General and Administrative Expense General and administrative expenses consist primarily of personnel-related expenses, including salaries, bonuses, benefits, and stock-based compensation expenses for individuals in executive, finance, corporate, business development, and administrative functions.
General and Administrative Expense General and administrative expenses consist primarily of personnel-related expenses, including salaries, bonuses, benefits, and stock-based compensation expenses for individuals in executive, finance, corporate, business development, and administrative functions.
X 19.1 Insider Trading Policy. X 21.1 List of Subsidiaries. X 23.1 Consent of KPMG LLP, independent registered public accounting firm. X 24.1 Power of Attorney (included on signature page of Annual Report).
S-3 333-290688 1.2 10/02/2025 19.1 Insider Trading Policy. 10-K 001-42279 19.1 03/20/2025 21.1 List of Subsidiaries. 10-K 001-42279 21.1 03/20/2025 23.1 Consent of KPMG LLP, independent registered public accounting firm. X 24.1 Power of Attorney (included on signature page of Annual Report).
Our Senior Director of Information Technology, under the supervision of our Chief Financial Officer, manages and monitors our cybersecurity risk (including that presented by our information technology service providers). Our Senior Director of Information Technology is responsible for informing our Chief Financial Officer of relevant cybersecurity risks including, as relevant, the prevent, detection, mitigation and remediation of cybersecurity incidents.
Our Senior Director of Information Technology, under the supervision of our Chief Financial Officer, manages and monitors our cybersecurity risk (including that presented by our information technology service providers) and is responsible for the day-to-day management of our cybersecurity program, including processes relating to the assessment, identification, prevention, detection, mitigation and remediation of cybersecurity threats and incidents .
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. We expect to recognize revenue in the future from the Novartis Agreement, which may include amounts related to upfront payments, milestone payments, and research and development funding.
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.
We expect that our research and development expenses will continue to increase substantially for the foreseeable future as we progress BGE-102 or other NLRP3 inhibitors that we are developing for the treatment of obesity toward the submission of an IND application and into a Phase 1 clinical trial, continue to discover and develop additional product candidates, expand our headcount and costs related to our existing and potential future intellectual property licenses.
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.
X 32.2* Certification of Principal Financial Officer Pursuant to 18 U.S.C. Section 1350, as X 113 Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. 97.1 Compensation Recovery Policy. X 101.INS Inline XBRL Instance Document – the instance document does not appear in the Interactive Data File because XBRL tags are embedded within the Inline XBRL document.
Section 1350, as X 128 Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. 97.1 Compensation Recovery Policy. 10-K 001-42279 97.1 03/20/2025 101.INS Inline XBRL Instance Document – the instance document does not appear in the Interactive Data File because XBRL tags are embedded within the Inline XBRL document.
In future periods, we expect our stock-based compensation expense to increase, due in part to our existing unrecognized stock-based compensation expense and as we grant additional stock-based awards to continue to attract and retain our employees.
In future periods, we expect our stock-based compensation expense to increase, due in part to our existing unrecognized stock-based compensation expense and as we grant additional stock-based awards to continue to attract and retain our employees. Revenue Recognition Our revenues are generated primarily through collaborative research, license, development and commercialization agreements.
Management’s annual report on internal control over financial reporting This Annual Report on Form 10-K does not include a report of management’s assessment regarding our internal control over financial reporting or an attestation report of our independent registered accounting firm due to a transition period established by rules of the SEC for newly public companies.
Attestation Report of the Registered Public Accounting Firm This Annual Report on Form 10-K does not include an attestation report of our independent registered public accounting firm regarding internal control over financial reporting.

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