Bicara Therapeutics Inc.

11/10/2025 | Press release | Distributed by Public on 11/10/2025 15:27

Quarterly Report for Quarter Ending September 30, 2025 (Form 10-Q)

Management's Discussion and Analysis of Financial Condition and Results of Operations.
The following discussion and analysis of our financial condition should be read in conjunction with our unaudited financial statements and related notes appearing elsewhere in this Quarterly Report on Form 10-Q. Some of the information contained in this discussion and analysis or set forth elsewhere in this Quarterly Report on Form 10-Q, including information with respect to our future results of operations or financial condition, business strategy and plans and objectives of management for future operations, includes forward-looking statements that involve risks and uncertainties and should be read together with the "Risk Factors" section of this Quarterly Report on Form 10-Q for a discussion of important factors that could cause our actual results to differ materially from those described in or implied by these forward-looking statements contained in the following discussion and analysis. Please also see the section titled "Special Note Regarding Forward-Looking Statements."
Overview
We are a clinical-stage biopharmaceutical company committed to bringing transformative bifunctional therapies to patients with solid tumors. Our lead program ficerafusp alfa is a potential first-in-class bifunctional antibody designed to drive tumor penetration by breaking barriers in the tumor microenvironment that have challenged the treatment of multiple solid tumor cancers. Specifically, ficerafusp alfa combines two clinically validated targets, an epidermal growth factor receptor, or EGFR, directed monoclonal antibody with a domain that binds to human transforming growth factor beta, or TGF-β. Through this dual-targeting mechanism, ficerafusp alfa may reverse the fibrotic and immune-excluded tumor microenvironment driven by TGF-β signaling and enable tumor penetration to potentially drive deep and durable responses. Ficerafusp alfa is initially being developed in head and neck squamous cell carcinoma, or HNSCC, where there remains a significant unmet need. We initiated a pivotal FORTIFI-HN01 Phase 2/3 trial, or FORTIFI-HN01 Phase 2/3 trial, or FORTIFI-HN01, of ficerafusp alfa in combination with pembrolizumab as a first-line therapy in recurrent/metastatic, HNSCC excluding patients with HPV-positive oropharyngeal squamous cell carcinoma, or OPSCC, in the fourth quarter of 2024.
Since our inception in December 2018, we have not generated any revenue from product sales or other sources and have incurred significant operating losses and negative cash flows from our operations. Our primary uses of cash to date have been conducting research and development, advancing development of ficerafusp alfa, raising capital, building infrastructure, developing intellectual property, hiring personnel and providing general and administrative support for these operations. To date, we have funded our operations primarily through private placements of our redeemable convertible preferred stock, sale of common stock and through debt financing. As ofSeptember30, 2025, we had raised aggregate net proceeds of $688.3million and had cash, cash equivalentsand investments of $407.6 million.
We have incurred operating losses in each year since our inception. Our net losses were $36.3 millionand $17.5 millionfor the three months ended September 30, 2025 and 2024, respectively. Our net losses were $100.6 millionand $47.0 millionfor the nine months ended September 30, 2025 and 2024, respectively. As of September 30, 2025, we had an accumulated deficit of $321.6 million. We expect our expenses and operating losses will increase substantially as we:
•conduct our current and future clinical trials;
•continue our research and development activities;
•utilize third parties to manufacture our product candidate and related raw materials or, should we decide to do so, build and maintain a commercial-scale current good manufacturing practice, or cGMP, manufacturing facility;
•hire additional research and development, clinical and commercial, and operational personnel;
•add quality control, quality assurance, legal, compliance, and other groups to support our operations;
•maintain, expand, enforce, defend and protect our intellectual property portfolio (including intellectual property obtained through license agreements) and provide reimbursement of third-party expenses related to our patent portfolio;
•seek regulatory approvals for ficerafusp alfa or any future product candidates for which we successfully complete clinical trials;
•ultimately establish a sales, marketing and distribution infrastructure to commercialize ficerafusp alfa or any future product candidates for which we may obtain marketing approval; and
•make any payments due under potential license agreements and any potential milestones, royalties or other payments due under any future in-license or collaboration agreements.
Our net losses may fluctuate significantly from quarter-to-quarter and year-to-year, depending on the timing of our planned clinical trials, manufacturing and research and development activities.
Based upon our current operating plans, we believe that our existing cash, cash equivalents and investments will be sufficient to fund our operationsintothe first half of 2029. Without additional funding, we believe that we will have sufficient funds to meet our obligations within the next twelve months from the date of issuance of ourcondensed consolidated financial statements. We do not expect to generate any revenue from product sales unless and until we successfully complete development and obtain regulatory approval for ficerafusp alfa or future product candidates, we expect to incur significant commercialization expenses related to product sales, marketing, manufacturing and distribution. Accordingly, until such time as we can generate significant revenue from sales of our product candidate, if ever, we expect to finance our cash needs through equity offerings, debt financings or other capital sources, including potential collaborations, licenses and other similar arrangements. See the section titled "Liquidity and Capital Resources" below. However, we may be unable to raise additional funds or enter into such other arrangements when needed on favorable terms or at all. Our failure to raise capital or enter into such other arrangements when needed would have a negative impact on our financial condition and could force us to delay, limit, reduce or terminate our product development or future commercialization efforts or grant rights to develop and market product candidate that we would otherwise prefer to develop and market ourselves.
Our Pipeline
Our current development plan for ficerafusp alfa is summarized in the following pipeline chart:
Phase 1/1b Clinical Trial Highlights
In June 2025, we presented data from our Phase 1/1b clinical trial of ficerafusp alfa 1500mg weekly in combination with pembrolizumab in patients with first line, or 1L, recurrent/metastatic, or R/M HPV-negative HNSCC with a PD-L1 combined positive score of ≥1 and with at least 24 months of follow-up at the 2025 American Society of Clinical Oncology Annual Meeting. Key highlights from the presentation include that the combination continued to demonstrate a manageable safety profile and resulted in deep and durable anti-tumor activity with improved overall survival, or OS, compared to historical benchmarks of pembrolizumab alone or in combination with chemotherapy in patients with 1L R/M HPV-negative HNSCC. Specifically, in the efficacy evaluable HPV-negative population (n=28), the confirmed objective response rate, or ORR, was 54% (15/28), of which 80% (12/15) of responders achieved a deep response (≥80% tumor shrinkage) and the median duration of response was 21.7 months. The median OS was 21.3 months and the 2-year OS rate was 46%.
Ficerafusp alfa 1500mg weekly and 750mg weekly are both currently being explored in combination with pembrolizumab in the dose optimization portion of the ongoing FORTIFI-HN01 Phase 2/3 trial. Additional data from an ongoing, open-label Phase 1/1b clinical trial of ficerafusp alfa 750mg weekly in combination with pembrolizumab in patients with 1L R/M HPV-negative HNSCC with a PD-L1 combined positive score of ≥1 will be presented at the European Society for Medical Oncology (ESMO) Asia Congress in 2025.
Components of Results of Operations
Revenue
We currently have no products approved for sale, and we have not generated any revenue to date. In the future, we may generate revenue from collaboration or license agreements we may enter into with respect to our product candidate, as well as product sales from any approved product, which approval we do not expect to occur for at least the next several years, if ever. Our ability to generate product revenue will depend on the successful development and eventual commercialization of ficerafusp alfa and any future product candidates we pursue. If we fail to complete clinical development of or to obtain regulatory approval for ficerafusp alfa or any future product candidates, our ability to generate future revenues, and our results of operations and financial position would be adversely affected.
Operating Expenses
Research and Development (including Research and Development-Related Party)
Research and development expenses (including related party research and development) have primarily consisted of external and internal costs associated with our research and development activities, including the development of our bifunctional ficerafusp alfa antibody therapies to treat solid tumors, and the clinical development of our product candidate. Our research and development expenses include:
•external expenses, including expenses incurred under arrangements with third parties, such as sponsored research agreements, consultants and our scientific advisors;
•the cost to obtain licenses to intellectual property;
•personnel-related costs, including salaries, bonuses, benefits, and stock-based compensation for employees engaged in research and development functions;
•costs for laboratory supplies, research materials and reagents; and
•the cost of developing and validating our manufacturing process for use in our future clinical trials;
Most of our research and development expenses have been related to the development of ficerafusp alfa. We use our personnel and infrastructure resources across the breadth of our research and development activities, which are directed toward identifying and developing our product candidate.
We expense all research and development costs in the periods in which they are incurred. Costs for certain research and development activities are recognized based on an evaluation of the progress to completion of specific tasks using information and data provided to us by our vendors, related parties and third-party service providers.
We plan to substantially increase our research and development expenses for the foreseeable future as we continue with the development of ficerafusp alfa and any other product candidates we may determine to pursue. Due to the inherently unpredictable nature of pre-clinical and clinical development, we cannot determine with certainty the timing of the initiation, duration or costs of future clinical trials and pre-clinical studies of product candidates. The timelines and costs associated with research and development activities are uncertain and can vary significantly for any product candidate we pursue, and development programs are inherently unpredictable nature of clinical development. We anticipate we will make determinations as to which programs to pursue and how much funding to direct to each current program on an ongoing basis in response to clinical results, regulatory developments, and ongoing assessments as to each program's commercial potential.
Research and development activities are central to our business model. Therapeutic candidates in 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. As a result, we expect that our research and development expenses will increase substantially over the next several years as we expect to (i) advance ficerafusp alfa into late-stage clinical trials, (ii) develop ficerafusp alfa for other potential indications and (iii) expand our manufacturing efforts.
Our future development costs may vary significantly based on various factors such as timely and successful completion of clinical trials, positive results from our future clinical trials, receipt of marketing approvals from applicable regulatory authorities, establishment of arrangements with third parties, intellectual property updates, and continued acceptable safety, tolerability and efficacy profile of any product candidates that we may develop following approval. Any changes in the outcome of any of these variables with respect to the development of our therapeutic candidates in preclinical and clinical development could mean a significant change in the costs and timing associated with the development of these therapeutic candidates. For example, if the FDA 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 of our planned clinical trials, we could be required to expend significant additional financial resources and time to complete clinical development of that therapeutic candidate. We may never obtain regulatory approval for any of our therapeutic candidates, and, even if we do, drug commercialization takes several years and millions of dollars in development costs.
General and Administrative
General and administrative expenses consist primarily of personnel-related costs, including salaries, bonuses, benefits, and stock-based compensation charges for those individuals in executive, legal, finance, human resources, facility operations, and other administrative functions. Other significant costs include legal fees relating to intellectual property, litigation and corporate matters, professional fees for auditing, accounting, tax and consulting services, office and information technology costs, insurance costs, and facilities, depreciation and other general and administrative expenses, which include rent and maintenance of facilities and utilities.
We anticipate that our general and administrative expenses will increase for the foreseeable future to support our increased research and development activities. We also anticipate increased expenses related to audit, accounting, legal, regulatory, and tax-related services associated with maintaining compliance with our Nasdaq and Securities and Exchange Commission, or SEC, requirements, director and officer insurance premiums, and investor relations costs associated with operating as a public company.
Other Income
Interest income
Interest income consists primarily of interest income earned on cash, cash equivalents and investments.
Income Taxes
The Company's provision for income taxes is not material for the three and nine months ended September 30, 2025 and 2024.
Since our inception, we have not recorded any U.S. federal or state income tax benefits for the net losses we have incurred in each year or our earned research and development tax credits, due to our uncertainty of realizing a benefit from those items.
Results of Operations
Comparison of the three months ended September 30, 2025 and 2024
The following table summarizes our results of operations for the three months ended September 30, 2025 and 2024 (in thousands):
Three Months Ended September 30,
2025 2024 Change
Operating Expenses:
Research and development-related party $ 5,817 $ 2,310 $ 3,507
Research and development 27,158 13,554 13,604
General and administrative 7,701 4,764 2,937
Total operating expenses 40,676 20,628 20,048
Loss from operations (40,676) (20,628) (20,048)
Other income
Interest income 4,386 3,147 1,239
Total other income 4,386 3,147 1,239
Net loss before income taxes (36,290) (17,481) (18,809)
Income tax expense (40) - (40)
Net loss $ (36,330) $ (17,481) $ (18,849)
Research and Development Expenses (including Research and Development-Related Party)
Research and development expenses increased by $17.1 million from $15.9 million for the three months ended September 30, 2024 to $33.0 million for the three months ended September 30, 2025.
The following table summarizes our research and development expenses for the three months ended September 30, 2025 and 2024 (in thousands):
Three Months Ended September 30,
2025 2024 Change
Research
$ 1,341 $ 448 $ 893
Manufacturing and process development
10,967 7,107 3,860
Clinical operations and development
13,957 5,339 8,618
Research and development personnel cost and other (including stock-based compensation)
6,710 2,970 3,740
Total research and development expenses
$ 32,975 $ 15,864 $ 17,111
The increase in research and development expenses for the three months ended September 30, 2025, compared to the three months ended September 30, 2024 was primarily due to:
•approximately $8.6 millionin increased clinical operation and development cost, driven by costs associated with our pivotal Phase 2/3 clinical trial and continued patient enrollment in our Phase 1/1b dose expansion cohorts;
•approximately $3.7 millionin increased personnel and other related costs including stock-based compensation, driven by an increase in the size of our workforce to support clinical operations and development, manufacturing, and research and increased professional service expenses as we continue to build out our clinical operations and development functions; and
•approximately $3.9 million in increased manufacturing cost, driven by an increase in drug substance batch manufacturing in connection with our pivotal Phase 2/3 and Phase 1/1b clinical trials.
General and Administrative Expenses
General and administrative expenses increased by $2.9 million from $4.8 million for the threemonths ended September 30, 2024 to $7.7 million for thethreemonths ended September 30, 2025. The following table summarizes our general and administrative expenses for the three months ended September 30, 2025 and 2024 (in thousands):
Three Months Ended September 30,
2025
2024
Change
General and administrative personnel costs (including stock-based compensation)
$ 5,190 $ 3,312 $ 1,878
Professional fees
1,586 870 716
Facility costs,insurance, IT, office expense and other
925 582 343
Total general and administrative expenses
$ 7,701 $ 4,764 $ 2,937
The increase in general and administrative expenses for the three months ended September 30, 2025, compared to the three months ended September 30, 2024 was primarily due to:
•approximately $1.9 millionin increased personnel related costs, including stock-based compensation, primarily driven by an increase in the size of our workforce and due to a higher number and value of stock options granted;
•approximately $0.7 millionin increased professional service expenses, including legal, accounting and other expenses as we continue to build out our general and administrative functions to support advancing our clinical studies and operating a publicly traded company; and
•approximately $0.3 millionin increased expenses for insurance policies entered into for directors and officers, rental expense from the additional lease entered into in the second half of 2024, rental expense from the sublease entered into in the second half of 2025 and information technology expenses.
Other Income
Interest income
Interest income for the three months ended September 30, 2025 and 2024 was $4.4 million and $3.1 million, respectively. The increase was primarily due to a significant increase in cash equivalents and investments, as a result of proceeds from the sale of common stock in our initial public offering in 2024.
Comparison of the nine months ended September 30, 2025 and 2024
The following table summarizes our results of operations for the nine months ended September 30, 2025 and 2024 (in thousands):
Nine Months Ended September 30,
2025 2024 Change
Operating Expenses:
Research and development-related party $ 15,324 $ 7,400 $ 7,924
Research and development 76,782 36,336 40,446
General and administrative 22,376 12,016 10,360
Total operating expenses 114,482 55,752 58,730
Loss from operations (114,482) (55,752) (58,730)
Other income
Interest income 14,082 8,715 5,367
Total other income 14,082 8,715 5,367
Net loss before income taxes (100,400) (47,037) (53,363)
Income tax expense (164) (1) (163)
Net loss $ (100,564) $ (47,038) $ (53,526)
Research and Development Expenses (including Research and Development-Related Party)
Research and development expenses increased by $48.4 million from $43.7 million for the nine months ended September 30, 2024, to $92.1 million for the nine months ended September 30, 2025.
The following table summarizes our research and development expenses for the nine months ended September 30, 2025 and 2024 (in thousands):
Nine Months Ended September 30,
2025 2024 Change
Research
$ 2,440 $ 1,780 $ 660
Manufacturing and process development
37,888 20,046 17,842
Clinical operations and development
34,444 15,113 19,331
Research and development personnel cost and other (including stock-based compensation)
17,334 6,797 10,537
Total research and development expenses
$ 92,106 $ 43,736 $ 48,370
The increase in research and development expenses for the nine months ended September 30, 2025, compared to the nine months ended September 30, 2024 was primarily due to:
•approximately $17.8 millionin increased manufacturing cost, driven by an increase in drug substance batch manufacturing in connection with our Phase 1/1b and our pivotal Phase 2/3 clinical trial;
•approximately $19.3 millionin increased clinical operation and development cost, driven by costs associated with our pivotal Phase 2/3 clinical trial and continued patient enrollment in our Phase 1/1b dose expansion cohorts; and
•approximately $10.5 millionin increased personnel and other related costs including stock-based compensation, driven by an increase in the size of our workforce to support clinical operations and development, manufacturing, and research and increased professional service expenses as we continue to build out our clinical operations and development functions.
General and Administrative Expenses
General and administrative expenses increased by $10.4 million from $12.0 million for theninemonths ended September 30, 2024, to $22.4 million for theninemonths ended September30, 2025. The following table summarizes our general and administrative expenses for theninemonths ended September 30, 2025 and 2024 (in thousands):
Nine Months Ended September 30,
2025
2024
Change
General and administrative personnel costs (including stock-based compensation)
$ 14,876 $ 8,127 $ 6,749
Professional fees
4,482 2,463 2,019
Facility costs,insurance, IT, office expense and other
3,018 1,426 1,592
Total general and administrative expenses
$ 22,376 $ 12,016 $ 10,360
The increase in general and administrative expenses for the nine months ended September 30, 2025, compared to the nine months ended September 30, 2024 was primarily due to:
•approximately $6.7 millionin increased personnel related costs, including stock-based compensation, primarily driven by an increase in the size of our workforce and due to a higher number and value of stock options granted;
•approximately $2.0 millionin increased professional service expenses, including legal, accounting and other expenses as we continue to build out our general and administrative functions to support advancing our clinical studies and operating a publicly traded company; and
•approximately $1.6 millionin increased expenses for insurance policies entered into for directors and officers, rental expense from the additional lease entered into in the second half of 2024, rental expense from the sublease entered into in the second half of 2025, and information technology expenses.
Other Income
Interest income
Interest income for the nine months ended September 30, 2025 and 2024 was $14.1 million and $8.7 million, respectively. The increase was primarily due to a significant increase in cash equivalents and investments, as a result of proceeds from the sale of common stock in our initial public offering in 2024.
Liquidity and Capital Resources
Sources of Liquidity
Since our inception in December 2018, we have not generated any revenue from any sources and have incurred significant operating losses and negative cash flows from operations. We expect to incur significant expenses and operating losses for the foreseeable future as we advance the clinical development of ficerafusp alfa or any future product candidates we elect to pursue. From our inception in December 2018 through September 30, 2025, we have received aggregate net proceeds of $688.3 million from the sale of our common stock in connection with the IPO and exercise of stock options, sale of our redeemable convertible preferred stock in private placements and debt financing.
On October 3, 2025, we filed a Registration Statement on Form S-3 with the SEC covering the offering of up to $400.0 million of common stock, preferred stock, debt securities, warrants and/or units. The Registration Statement has not yet been declared effective by the SEC. Concurrent with the filing of the Registration Statement, we entered into a sales agreement, dated October 3, 2025, by and between the Company and TD Securities (USA) LLC, acting as sales agent, to establish an at-the-market offering program pursuant to which we may offer and sell shares of our common stock from time to time, or the ATM Program. In connection with the ATM Program, we filed a prospectus with the Registration Statement for the offer and sale of up to $150.0 million of shares of common stock from time to time through the sales agent. To date, no shares have been sold through the ATM Program. As market conditions permit, we may offer and sell securities under the Registration Statement, including through the ATM Program, in order to fund our operations or provide additional liquidity.
Future Funding Requirements
As of September 30, 2025, we had cash, cash equivalentsand investments of $407.6 million. Based upon our current operating plans, we believe that our existing cash, cash equivalents and investments will be sufficient to fund our operationsintothe first half of 2029. However, our forecast of the period of time through which our financial resources will be adequate to support our operations is a forward-looking statement that involves risks and uncertainties, and actual results could vary materially. Additionally, the process of testing our product candidate in clinical trials is costly, and the timing of progress and expenses in these trials is uncertain. We will need to raise substantial additional capital in the future.
Our future capital requirements will depend on many factors, including but not limited to:
•the type, number, scope, progress, expansions, results, costs, and timing of clinical trials of ficerafusp alfa and future product candidates;
•the costs and timing of manufacturing for ficerafusp alfa and any future product candidates and commercial manufacturing thereof;
•the costs, timing, and outcome of regulatory review of ficerafusp alfa and any future product candidates;
•the terms and timing of establishing and maintaining licenses and other similar arrangements;
•the legal costs of obtaining, maintaining, and enforcing our patents and other intellectual property rights (including intellectual property obtained through license agreements);
•our efforts to enhance operational systems and hire additional personnel to satisfy our obligations as a public company;
•the costs associated with hiring additional personnel and consultants as our clinical activities increase;
•the costs and timing of establishing or securing sales and marketing capabilities if ficerafusp alfa or any future product candidate is approved;
•our ability to achieve sufficient market acceptance, coverage and adequate reimbursement from third-party payors and adequate market share and revenue for any approved products; and
•costs associated with any products or technologies that we may in-license or acquire.
Until such time, if ever, as we can generate substantial product revenue to support our cost structure, we expect to finance our cash needs through equity offerings, debt financings, or other capital sources, potentially including collaborations, licenses and other similar arrangements. However, we may be unable to raise additional funds or enter into such other arrangements when needed on favorable terms or at all. To the extent that we raise additional capital through the sale of equity or convertible debt securities, the ownership interest of our stockholders will be or could be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect the rights of our common stockholders. Debt financing and equity financing, if available, may involve agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures, or declaring dividends. If we raise funds through collaborations, or other similar arrangements with third parties, we may have to relinquish valuable rights to our technologies, future revenue streams, research programs or current or future product candidates or grant licenses on terms that may not be favorable to us and/or may reduce the value of our common stock. Our failure to raise capital or enter into such other arrangements when needed could have a negative impact on our financial condition and on our ability to pursue our business plans and strategies. 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 our current or future product candidates even if we would otherwise prefer to develop and market such product candidates ourselves.
Cash Flows
Comparison of the Nine Months Ended September 30, 2025 and 2024
The following table sets forth a summary of the net cash flow activity for theninemonths ended September 30, 2025 and 2024 (in thousands):
Nine Months Ended September 30,
2025 2024
Net cash used in operating activities
$ (82,948) $ (44,719)
Net cash (used in)/provided by investing activities
(236,121) 31
Net cash provided by financing activities
1,031 335,006
Net decrease in cash and cash equivalents
$ (318,038) $ 290,318
Operating Activities
For the nine months ended September 30, 2025, net cash used in operating activities was $82.9 million resulting from our net loss of $100.6 million, partially offset by net increases in our operating assets and liabilities of $6.4 million and by non-cash charges of $11.2 million, consisting of stock-based compensation expense, depreciation and non-cash lease expense.
For the nine months ended September 30, 2024, net cash used in operating activities was $44.7 million resulting from our net loss of $47.0 million and net decreasein our operating assets and liabilities of $2.1 million, partially offset by non-cash charges of $4.5 million. Non-cash charges consisted of stock-based compensation expense, depreciation and non-cash lease charges.
Investing Activities
Net cash used for investing activities was $236.1 million for the nine months ended September 30, 2025 and immaterial for September 30, 2024. The increase in cash used for investing activities consisted of investments made in U.S. treasury bills.
Financing Activities
Net cash provided by financing activities was $1.0 million for the nine months ended September 30, 2025, consisting primarily of proceeds from the exercise of stock options.
Net cash provided by financing activities was $335.0 million for the nine months ended September 30, 2024, consisting primarily of proceeds from the sale of common stock in our initial public offering in 2024 .
Critical Accounting Polices and Estimates
This discussion and analysis of our financial condition and results of operations is based on our condensed consolidated financial statements, which we have prepared in accordance with GAAP. The preparation of our financial statements and related disclosures requires us to make estimates, assumptions and judgments that affect the reported amount of assets, liabilities, costs and expenses, and related disclosures. During the three months ended September 30, 2025, there were no material changes to our critical accounting policies and significant judgments described under Management's Discussion and Analysis of Critical Accounting Policies and Significant Judgments which are included in our Annual Report on Form 10-K for the fiscal year ended December 31, 2024, or Form 10-K.
Emerging Growth Company and Smaller Reporting Company Status
We qualify as an "emerging growth company," as defined in the Jumpstart Our Business Startups Act of 2012. As an emerging growth company, we may take advantage of specified reduced disclosure and other requirements that are otherwise applicable generally to public companies. These provisions include: (i) being permitted to present only two years of audited financial statements, in addition to any required unaudited interim financial statements, with correspondingly reduced "Management's Discussion and Analysis of Financial Condition and Results of Operations" disclosure in this Quarterly Report on Form 10-Q; (ii) reduced disclosure about our executive compensation arrangements; (iii) not being required to hold advisory votes on executive compensation or to obtain stockholder
approval of any golden parachute arrangements not previously approved; (iv) an exemption from the auditor attestation requirement in the assessment of our internal control over financial reporting pursuant to the Sarbanes-Oxley Act; and (v) an exemption from compliance with the requirements of the Public Company Accounting Oversight Board regarding the communication of critical audit matters in the auditor's report on the financial statements.
We may take advantage of these exemptions for up to five years or such earlier time that we are no longer an emerging growth company. We would cease to be an emerging growth company on the date that is the earliest of (i) the last day of the fiscal year in which we have total annual gross revenues of $1.235 billion or more; (ii) the last day of our fiscal year following the fifth anniversary of the date of the completion of our IPO; (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 may choose to take advantage of some but not all of these exemptions. We have elected to avail ourselves of this exemption and, therefore, while we are an emerging growth company we will not be subject to new or revised accounting standards at the same time that they become applicable to other public companies that are not emerging growth companies. As a result of this election, our financial statements may not be comparable to those of other public companies that comply with new or revised accounting pronouncements as of public company effective dates. We may choose to early adopt any new or revised accounting standards whenever such early adoption is permitted for private companies.
We are also a "smaller reporting company" as defined in the Securities Exchange Act of 1934, as amended. We may continue to be a smaller reporting company even after we are no longer an emerging growth company. We may take advantage of certain of the scaled disclosures available to smaller reporting companies and will be able to take advantage of these scaled disclosures for so long as the market value of our shares of common stock held by non-affiliates is less than $250.0 million measured on the last business day of our second fiscal quarter, or our annual revenue is less than $100.0 million during the most recently completed fiscal year and the market value of our shares of common stock held by non-affiliates is less than $700.0 million measured on the last business day of our second fiscal quarter.
Recent Accounting Pronouncements
A description of recently issued accounting pronouncements that may potentially impact our financial position and results of operations is disclosed in Note 2 titled "Summary of Significant Accounting Policies" to our condensed consolidated financial statements included elsewhere in thisQuarterly Report on Form 10-Q.
Bicara Therapeutics Inc. published this content on November 10, 2025, and is solely responsible for the information contained herein. Distributed via Edgar on November 10, 2025 at 21:28 UTC. If you believe the information included in the content is inaccurate or outdated and requires editing or removal, please contact us at [email protected]