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Bicara Therapeutics Inc.

For the period ended Sep 30, 2025. Filed Nov 10, 2025.

View on SEC.gov

About this filing

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

Sep 30, 2025 · Filed Nov 10, 2025

BCAX$8.65+5.6%Stored close · as of Nov 6, 2026

What changed in Management’s Discussion and Analysis?

Read the current filing

Previous report: 10-Q

Period ended 2025-06-30; filed 2025-08-12.

0002023658-25-000098

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

Current report: 10-Q

Period ended 2025-09-30; filed 2025-11-10.

0002023658-25-000109

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

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

Compared 107 previous paragraphs and 114 current paragraphs.

71 unchanged; 28 reworded; 13 added; 7 removed; 1 previous and 2 current paragraphs rearranged.

Tables are not compared: 7 previous and 7 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.

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

Added paragraphs (13)

Current report

Our current development plan for ficerafusp alfa is summarized in the following pipeline chart:

Current report

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%.

Current report

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.

Current report

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.

Current report

Comparison of the nine months ended September 30, 2025 and 2024

Current report

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.

Current report

The following table summarizes our research and development expenses for the nine months ended September 30, 2025 and 2024 (in thousands):

Current report

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:

Current report

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.

Current report

Comparison of the Nine Months Ended September 30, 2025 and 2024

Current report

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.
Removed paragraphs (7)

Previous report

Research and development expenses increased by $9.0 million from $15.8 million for the three months ended June 30, 2024 to$24.8 million for the three months ended June 30, 2025.

Previous report

Research and development expenses increased by $31.3 million from $27.9 million for the six months ended June 30, 2024, to $59.1 million for the six months ended June 30, 2025.

Previous report

The following table summarizes our research and development expenses for the six months ended June 30, 2025 and 2024 (in thousands):

Previous report

The increase in research and development expenses for the six months ended June 30, 2025, compared to the six months ended June 30, 2024 was primarily due to:

Previous report

Net cash provided by investing activities was $0.0 million for the six months ended June 30, 2025 and immaterial for June 30, 2024.
Reworded paragraphs (28)

Previous wording

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 of June 30, 2025, we had raised aggregate net proceeds of $687.8 million and had cash and cash equivalents of$436.6 million.

Current wording

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 of September 30, 2025, we had raised aggregate net proceeds of $688.3 million and had cash, cash equivalents and investmentsof$407.6 million.

Previous wording

We have incurred operating losses in each year since our inception. Our net losses were$27.4 million and$17.0 million for the three months ended June 30, 2025 and 2024, respectively. Our net losses were$64.2 million and$29.6 million for the six months ended June 30, 2025 and 2024, respectively. As of June 30, 2025, we had an accumulated deficit of$285.3 million. We expect our expenses and operating losses will increase substantially as we:

Current wording

We have incurred operating losses in each year since our inception. Our net losses were$36.3 million and$17.5 million for the three months ended September 30, 2025 and 2024, respectively. Our net losses were$100.6 million and$47.0 million for 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:

Previous wording

Based upon our current operating plans, we believe that our existing cash and cash equivalents will be sufficient to fund our operations into the 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 our condensed 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.

Current wording

Based upon our current operating plans, we believe that our existing cash, cash equivalents and investments will be sufficient to fund our operations into the 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 our condensed 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.

Previous wording

Interest income consists primarily of interest income earned on cash and cash equivalents. We expect our interest income will increase as we invest the cash received from the sales of our common stock in our initial public offering in 2024.

Current wording

Interest income consists primarily of interest income earned on cash, cash equivalents and investments.

Previous wording

The Company’s provision for income taxes is not material for the three and six months ended June 30, 2025 and 2024.

Current wording

The Company’s provision for income taxes is not material for the three and nine months ended September 30, 2025 and 2024.

Previous wording

•approximately$10.7 million in 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

Current wording

•approximately$8.6 million in 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;

Previous wording

•approximately$6.8 million in increased personnel and other related costs including stock-based compensation, driven by an increase in the size of our workforce to support clinical development, manufacturing and research and increased professional service expenses as we continue to build out our clinical operations and development functions.

Current wording

•approximately$3.7 million in 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

Previous wording

General and administrative expenses increased by$3.3 million from $3.9 million for the three months ended June 30, 2024 to $7.2 million for the three months ended June 30, 2025. The following table summarizes our general and administrative expenses for the three months ended June 30, 2025 and 2024 (in thousands):

Current wording

General and administrative expenses increased by$2.9 million from $4.8 million for the three months ended September 30, 2024 to $7.7 million for the three months 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):

Previous wording

•approximately$2.5 million in 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;

Current wording

•approximately$1.9 million in 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;

Previous wording

•approximately$0.3 million in 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

Current wording

•approximately$0.7 million in 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

Previous wording

•approximately$0.5 million in 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 and information technology expenses.

Current wording

•approximately$0.3 million in 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.

Previous wording

Interest income for the three months ended June 30, 2025 and 2024 was $4.7 million and $2.7 million, respectively. The increase was primarily due to a significant increase in cash equivalents, as a result of proceeds from the sale of common stock.

Current wording

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.

Previous wording

The following table summarizes our results of operations for the six months ended June 30, 2025 and 2024 (in thousands):

Current wording

The following table summarizes our results of operations for the nine months ended September 30, 2025 and 2024 (in thousands):

Previous wording

•approximately$14.0 million in 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;

Current wording

•approximately$17.8 million in 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;

Previous wording

•approximately$5.8 million in 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

Current wording

•approximately$19.3 million in 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

Previous wording

•approximately$3.5 million in increased personnel and other related costs including stock-based compensation, driven by an increase in the size of our workforce to support clinical development, manufacturing and research and increased professional service expenses as we continue to build out our clinical operations and development functions.

Current wording

•approximately$10.5 million in 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.

Previous wording

General and administrative expenses increased by$7.4 million from $7.3 million for the six months ended June 30, 2024, to $14.7 million for the six months ended June 30, 2025. The following table summarizes our general and administrative expenses for the six months ended June 30, 2025 and 2024 (in thousands):

Current wording

General and administrative expenses increased by$10.4 million from $12.0 million for the nine months ended September 30, 2024, to $22.4 million for the nine months ended September 30, 2025. The following table summarizes our general and administrative expenses for the nine months ended September 30, 2025 and 2024 (in thousands):

Previous wording

The increase in general and administrative expenses for the six months ended June 30, 2025, compared to the six months ended June 30, 2024 was primarily due to:

Current wording

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:

Previous wording

•approximately$4.9 million in 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;

Current wording

•approximately$6.7 million in 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;

Previous wording

•approximately$1.3 million in 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

Current wording

•approximately$2.0 million in 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

Previous wording

•approximately$1.2 million in 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 and information technology expenses.

Current wording

•approximately$1.6 million in 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.

Previous wording

Interest income for the six months ended June 30, 2025 and 2024 was $9.7 million and $5.6 million, respectively. The increase was primarily due to significant increase in cash equivalents, as a result of proceeds from the sale of common stock.

Current wording

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.

Previous wording

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 June 30, 2025, we have received aggregate net proceeds of $687.8 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.

Current wording

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.

Previous wording

As of June 30, 2025, we had cash and cash equivalents of$436.6 million. Based upon our current operating plans, we believe that our existing cash and cash equivalents will be sufficient to fund our operations into the 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.

Current wording

As of September 30, 2025, we had cash, cash equivalents and investmentsof$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 operations into the 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.

Previous wording

The following table sets forth a summary of the net cash flow activity for the six months ended June 30, 2025 and 2024 (in thousands):

Current wording

The following table sets forth a summary of the net cash flow activity for the nine months ended September 30, 2025 and 2024 (in thousands):

Previous wording

For the six months ended June 30, 2025, net cash used in operating activities was $53.7 million resulting from our net loss of $64.2 million, partially offset by net increases in our operating assets and liabilities of $3.2 million and by non-cash charges of $7.3 million, consisting of stock-based compensation expense, depreciation and non-cash lease expense.

Current wording

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.

Previous wording

For the six months ended June 30, 2024, net cash used in operating activities was $27.5 million resulting from our net loss of $29.6 million andnet decrease in our operating assets and liabilities of $0.3 million, partially offset by non-cash charges of $2.4 million. Non-cash charges consisted of stock-based compensation expense, depreciation and non-cash lease charges.

Current wording

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 andnet decrease in 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.

Previous wording

Net cash provided by financing activities was $0.6 million and $0.9 million during the six months ended June 30, 2025 and 2024, respectively, consisting primarily of proceeds from the exercise of stock options.

Current wording

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.
Rearranged current paragraphs (2)

Current report — wording carried from elsewhere

•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.

Current report — wording carried from elsewhere

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 .
Rearranged previous paragraphs (1)

Previous report — wording carried elsewhere

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