11/06/2025 | Press release | Distributed by Public on 11/06/2025 15:56
Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations.
You should read the following discussion and analysis of our financial condition and results of operations in conjunction with our unaudited condensed consolidated financial statements and the related notes and other financial information included elsewhere in this Quarterly Report and with 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. This discussion and analysis and other parts of this Quarterly Report contain forward-looking statements based upon our current plans and expectations that involve risks, uncertainties and assumptions, such as statements regarding our plans, objectives, expectations, intentions and beliefs. Our actual results and the timing of events could differ materially from those anticipated in these forward-looking statements as a result of various factors, including those set forth under the section titled "Risk Factors" and elsewhere in this Quarterly Report. You should carefully read the section titled "Risk Factors" to gain an understanding of the important factors that could cause actual results to differ materially from our forward-looking statements. 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 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.
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.
We are also developing novel apelin receptor APJ agonists for obesity, including programs targeting both oral and parenteral (subcutaneous) administration. In preclinical obesity models, APJ agonism has demonstrated the ability to more than double the weight loss induced by a GLP-1R agonist while also restoring healthy body composition and improving muscle function. In June 2025, we announced an option agreement with JiKang Therapeutics for a novel APJ agonist antibody, as well as the filing of a U.S. provisional patent for novel small molecule APJ agonists. We intend to file INDs for both the oral and parenteral APJ programs by 2026 year end.
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. We do not have any products approved for sale and have not generated any revenue from product sales. 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. 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 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:
Our net losses may fluctuate significantly from period to period, depending on the timing of factors above.
We will not generate revenue from product sales unless and until we successfully complete clinical development and obtain regulatory approval for BGE-102 or a future product candidate. In addition, if we obtain regulatory approval for BGE-102 or a future product candidate and do not enter into a third-party commercialization partnership, we expect to incur significant expenses related to developing our commercialization capability to support product sales, marketing, manufacturing and distribution activities.
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.
Because of the numerous risks and uncertainties associated with development of product candidates, we are unable to predict the timing or amount of increased expenses or when or if we will be able to achieve or maintain profitability. Even if we are able to generate product sales, we may not become profitable. If we fail to become profitable or are unable to sustain profitability on a continuing basis, then we may be unable to continue our operations at planned levels and be forced to reduce or terminate our operations.
We oversee and manage third party Contract Development and Manufacturing Organizations (CDMOs) to support development and manufacture of our future product candidates. We expect to enter into commercial supply agreements with commercial manufacturers prior to any potential regulatory approval of any future product candidates. We believe our current manufacturers are able to supply the upcoming preclinical and clinical trials of future product candidates. Additional CDMOs may be on-boarded at later stages of clinical and commercial development for future product candidates.
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.
Collaboration Agreement with Novartis Pharma AG
On December 16, 2024 we entered into a collaboration agreement with Novartis to identify and validate novel therapeutic drug targets by investigating the biological mechanisms that drive diseases related to aging and mediate the beneficial effects of physical exercise.
Under the terms of the Novartis Agreement, we are obligated to perform additional analyses on our longitudinal human aging cohort datasets, to expand data included in our discovery platform, and perform other activities to enable the identification and validation of novel therapeutic drug targets.
In consideration for the rights granted under the Novartis Agreement, we 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. 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 $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.
Components of Our Results of Operations
Revenue
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.
We have recognized and expect to recognize collaboration revenue in the future from the Novartis Agreement, which may include amounts related to upfront payments, milestone payments, and research and development funding.
Operating Expenses
Our operating expenses consist of (i) research and development expenses and (ii) general and administrative expenses.
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:
Indirect Costs:
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. Payments for these development activities are based on the terms of the individual agreements, which may differ from the pattern of costs incurred, and are reflected in our financial statements as prepaid expenses or accrued expenses.
A significant portion of our research and development costs to date have been third-party direct costs, which we disclose on an individual product candidate basis after the completion of IND-enabling activities for that product candidate. 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.
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.
Our research and development expenses may vary significantly in the future based on factors, such as:
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.
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.
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. 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.
We expect that our general and administrative expenses will continue to increase in the foreseeable future as our business expands to support our continued research and development activities, including any future clinical trials. These increases will likely include increased costs related to the hiring of additional personnel and fees to outside consultants, among other expenses. We also anticipate increased expenses associated with being a public company, including costs for audit, legal, regulatory and tax-related services related to compliance with the rules and regulations of the SEC, listing standards applicable to companies listed on a national securities exchange, director and officer insurance premiums and investor relations costs. In addition, if we obtain regulatory approval for any product candidates we may develop in the future and do not enter into a third-party commercialization collaboration, we expect to incur significant expenses related to building a sales and marketing team to support product sales, marketing and distribution activities.
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.
Gain (Loss) from Changes in Fair Value of Warrants
Gain (loss) on changes in fair value consists of assessed changes in fair value of warrants to purchase our common stock.
Loss on Extinguishment of Convertible Promissory Notes
Loss on extinguishment of convertible promissory notes consists of the difference between the carrying value of our convertible promissory notes (including accrued interest) and related embedded derivative liability and the fair value of shares issued upon conversion of our convertible promissory notes into our Series D-1 Redeemable Convertible Preferred Stock in February 2024.
Income Taxes
Since our inception, we have not recorded any income tax benefits for the net losses we have incurred in each period or for our research and development tax credits, as we believe, based upon the weight of available evidence, that it is more likely than not that all of our net operating loss carryforwards and tax credits will not be realized. As of September 30, 2025 and December 31, 2024, we have recorded a full valuation allowance against our deferred tax assets.
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.
Results of Operations
Comparison of the Three Months Ended September 30, 2025 and 2024
The following table summarizes our results of operations for each of the periods presented (in thousands, except percentages):
|
Three Months Ended |
||||||||||||||||
|
2025 |
2024 |
$ Change |
% Change |
|||||||||||||
|
(unaudited) |
||||||||||||||||
|
Collaboration revenue |
$ |
2,054 |
$ |
- |
$ |
2,054 |
100 |
% |
||||||||
|
Operating expenses: |
||||||||||||||||
|
Research and development |
18,513 |
20,019 |
(1,506 |
) |
(8 |
)% |
||||||||||
|
General and administrative |
6,681 |
4,731 |
1,950 |
41 |
% |
|||||||||||
|
Total operating expenses |
25,194 |
24,750 |
444 |
2 |
% |
|||||||||||
|
Loss from operations |
$ |
(23,140 |
) |
$ |
(24,750 |
) |
$ |
1,610 |
(7 |
)% |
||||||
|
Other income (expense), net: |
||||||||||||||||
|
Interest expense |
(149 |
) |
(388 |
) |
239 |
(62 |
)% |
|||||||||
|
Interest and other income (expense), net |
3,160 |
2,037 |
1,123 |
55 |
% |
|||||||||||
|
(Loss) from changes in fair value on warrants |
(42 |
) |
(306 |
) |
264 |
(86 |
)% |
|||||||||
|
Total other income (expense), net |
2,969 |
1,343 |
1,626 |
121 |
% |
|||||||||||
|
Net loss |
$ |
(20,171 |
) |
$ |
(23,407 |
) |
$ |
3,236 |
(14 |
)% |
||||||
Collaboration Revenue
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.
Research and Development Expenses
The following table summarizes our research and development expenses for each of the periods presented (in thousands, except percentages):
|
Three Months Ended |
||||||||||||||||
|
2025 |
2024 |
$ Change |
% Change |
|||||||||||||
|
(unaudited) |
||||||||||||||||
|
Direct costs: |
||||||||||||||||
|
azelaprag |
$ |
(84 |
) |
$ |
12,977 |
$ |
(13,061 |
) |
(101 |
)% |
||||||
|
BGE-102 |
4,661 |
287 |
4,374 |
NM |
||||||||||||
|
Other programs |
7,671 |
1,215 |
6,456 |
531 |
% |
|||||||||||
|
Indirect costs: |
||||||||||||||||
|
Personnel-related expenses (including stock-based |
4,108 |
4,153 |
(45 |
) |
(1 |
)% |
||||||||||
|
Allocated facility and other expenses |
2,157 |
1,387 |
770 |
56 |
% |
|||||||||||
|
Total research and development expenses |
$ |
18,513 |
$ |
20,019 |
$ |
(1,506 |
) |
(8 |
)% |
|||||||
_____________________________________________________
NM indicates that the percentage change is not meaningful.
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.
General and Administrative Expenses
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.
Other Income (Expense), Net
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.
Comparison of the nine months ended September 30, 2025 and 2024
The following table summarizes our results of operations for each of the periods presented (in thousands, except percentages):
|
Nine Months Ended |
||||||||||||||||
|
2025 |
2024 |
$ Change |
% Change |
|||||||||||||
|
(unaudited) |
||||||||||||||||
|
Collaboration revenue |
$ |
5,917 |
$ |
- |
$ |
5,917 |
100 |
% |
||||||||
|
Operating expenses: |
||||||||||||||||
|
Research and development |
49,466 |
39,811 |
9,655 |
24 |
% |
|||||||||||
|
General and administrative |
20,808 |
13,021 |
7,787 |
60 |
% |
|||||||||||
|
Total operating expenses |
70,274 |
52,832 |
17,442 |
33 |
% |
|||||||||||
|
Loss from operations |
$ |
(64,357 |
) |
$ |
(52,832 |
) |
$ |
(11,525 |
) |
22 |
% |
|||||
|
Other income (expense), net: |
||||||||||||||||
|
Interest expense |
(605 |
) |
(2,048 |
) |
1,443 |
(70 |
)% |
|||||||||
|
Interest and other income (expense), net |
10,294 |
5,534 |
4,760 |
86 |
% |
|||||||||||
|
Gain (loss) from changes in fair value on warrants |
6 |
(384 |
) |
390 |
(102 |
)% |
||||||||||
|
Loss on extinguishment of debt |
- |
(250 |
) |
250 |
(100 |
)% |
||||||||||
|
Total other income (expense), net |
9,695 |
2,852 |
6,843 |
240 |
% |
|||||||||||
|
Net loss |
$ |
(54,662 |
) |
$ |
(49,980 |
) |
$ |
(4,682 |
) |
9 |
% |
|||||
Collaboration Revenue
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.
Research and Development Expenses
The following table summarizes our research and development expenses for each of the periods presented (in thousands, except percentages):
|
Nine Months Ended |
||||||||||||||||
|
2025 |
2024 |
$ Change |
% Change |
|||||||||||||
|
(unaudited) |
||||||||||||||||
|
Direct costs: |
||||||||||||||||
|
azelaprag |
$ |
2,716 |
$ |
20,192 |
$ |
(17,476 |
) |
(87 |
)% |
|||||||
|
BGE-102 |
9,819 |
287 |
9,532 |
NM |
||||||||||||
|
Other programs |
18,297 |
3,293 |
15,004 |
456 |
% |
|||||||||||
|
Indirect costs: |
||||||||||||||||
|
Personnel-related expenses (including stock-based |
13,283 |
11,843 |
1,440 |
12 |
% |
|||||||||||
|
Allocated facility and other expenses |
5,351 |
4,196 |
1,155 |
28 |
% |
|||||||||||
|
Total research and development expenses |
$ |
49,466 |
$ |
39,811 |
$ |
9,655 |
24 |
% |
||||||||
_____________________________________________________
NM indicates that the percentage change is not meaningful.
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.
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.
General and Administrative Expenses
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.
Other Income (Expense), Net
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.
Liquidity and Capital Resources
Sources of Liquidity
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.
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.
Cash Flows
The following table provides information regarding our cash flows for each of the periods presented (in thousands):
|
Nine Months Ended |
||||||||
|
2025 |
2024 |
|||||||
|
(unaudited) |
||||||||
|
Net cash used in operating activities |
$ |
(53,376 |
) |
$ |
(46,384 |
) |
||
|
Net cash used in investing activities |
(80,788 |
) |
(340 |
) |
||||
|
Net cash provided by (used in) financing activities |
(4,544 |
) |
356,297 |
|||||
|
Effects of exchange rate changes on cash, cash equivalents, and restricted cash |
(68 |
) |
(56 |
) |
||||
|
Net increase (decrease) in cash, cash equivalents, and restricted cash |
$ |
(138,776 |
) |
$ |
309,517 |
|||
Cash Used in Operating Activities
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.
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.
Cash Used in Investing Activities
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.
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.
Cash Provided by (Used in) Financing Activities
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.
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.
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. 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, 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.
Because of the numerous risks and uncertainties associated with research, development and commercialization of product candidates, we are unable to estimate the exact amount of our working capital requirements. Our future funding requirements will depend on, and could increase significantly as a result of, many factors, including:
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.
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. We currently have no credit facility or committed sources of capital. 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, that 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.
Contractual Obligations and Other Commitments
Lease Obligations
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.
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. Most contracts do not contain minimum purchase commitments and are cancellable by us upon written notice. Payments due upon cancellation consist of payments for services provided or expenses incurred, including non-cancelable obligations of our service provided up to one year after the date of cancellation.
Critical Accounting Policies and Estimates
Our management's discussion and analysis of our financial condition and results of operations is based on our unaudited condensed consolidated financial statements, which have been prepared in accordance with GAAP. The preparation of these unaudited condensed consolidated financial statements requires us to make estimates and judgments that affect the reported amounts of assets and liabilities and the reported amounts of income and expenses during the reporting period. We continually evaluate our estimates and judgments used in preparing our unaudited condensed consolidated financial statements and related disclosures. All estimates affect reported amounts of assets, liabilities, income and expenses. These estimates and judgments are also based on historical experience and other factors that are believed to be reasonable under the circumstances. Materially different results can occur as circumstances change and additional information becomes known.
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.
Revenue Recognition
ASC 606 applies to all contracts with customers, except for contracts that are within the scope of other standards. Under ASC 606, an entity recognizes revenue when its customer obtains control of promised goods or services, in an amount that reflects the consideration which the entity expects to receive in exchange for those goods or services. To determine revenue recognition for arrangements that an entity determines are within the scope of ASC 606, the entity performs the following five steps: (i) identify the contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when (or as) the entity satisfies a performance obligation.
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. 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. 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.
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.
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. 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.
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. If it is probable that a significant revenue reversal would not occur, the associated milestone value is included in the transaction price. Milestone payments that are not within the Company's or the licensee's control, such as regulatory approvals, are not considered probable of being achieved until those approvals are received and therefore revenue recognized is constrained as management is unable to assert that a reversal of revenue would not be probable. The transaction price is then allocated to each performance obligation on a relative standalone selling price basis, for which the Company recognizes revenue as or when the performance obligations under the contract are satisfied. At the end of each subsequent reporting period, the Company re-evaluates the probability of achievement of such development milestones and any related constraint, and, if necessary, adjusts its estimate of the overall transaction price. Any such adjustments are recorded on a cumulative catch-up basis, which would affect collaboration revenues and earnings in the period of adjustment.
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. To date, the Company has not recognized any royalty revenue resulting from any of its licensing arrangements.
Significant Financing Component - In determining the transaction price, the Company adjusts consideration for the effects of the time value of money if the timing of payments provides the Company with a significant benefit of financing. The Company does not assess whether a contract has a significant financing component if the expectation at contract inception is such that the period between payment by the licensees and the transfer of the promised goods or services to the licensees will be one year or less. The Company assessed each of its revenue arrangements in order to determine whether a significant financing component exists and concluded that a significant financing component does not exist in any of its arrangements.
Collaborative Arrangements - The Company has entered into collaboration agreements, which are within the scope of ASC 606, to discover, develop, manufacture and commercialize product candidates. 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. 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.
The Company analyzes its collaboration arrangements to assess whether the collaboration agreements are within the scope of ASC 808, Collaborative Arrangements ("ASC 808") to determine whether such arrangements involve joint operating activities performed by parties that are both active participants in the activities and exposed to significant risks and rewards dependent on the commercial success of such activities. This assessment is performed throughout the life of the arrangement based on changes in the responsibilities of all parties in the arrangement. 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 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.
Revenue related to performance obligations satisfied over time could be materially impacted as a result of changes in the estimated research effort to satisfy performance obligations or changes in the transaction price related to variable consideration.
Emerging Growth Company and Smaller Reporting Company Status
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.
We are also a "smaller reporting company," meaning that the market value of our stock held by non-affiliates is less than $700.0 million and our annual revenue is less than $100.0 million during the most recently completed fiscal year. We will continue to be a smaller reporting company if either (i) the market value of our stock held by non-affiliates is less than $250.0 million or (ii) our annual revenue is less than $100.0 million during the most recently completed fiscal year and the market value of our stock held by non-affiliates is less than $700.0 million.
If we are a smaller reporting company at the time we cease to be an emerging growth company, we may continue to rely on exemptions from certain disclosure requirements that are available to smaller reporting companies. 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.