Bicara Therapeutics Inc.

Previous wording

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 bifunctional antibody that 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 has the potential to exert potent anti-tumor activity by simultaneously blocking both cancer cell-intrinsic EGFR survival and proliferation, as well as the immunosuppressive TGF-β signaling within the tumor microenvironment, or TME. Ficerafusp alfa directs the TGF-β inhibitor into the immediate TME through the binding of EGFR on tumor cells, which we believe will lead to durable responses and an increase in overall survival, or OS, while reducing the adverse effects typically associated with systemic TGF-β inhibition. 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, early in the fourth quarter of 2024.

Current wording

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.

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 March 31, 2025, we had raised aggregate net proceeds of$687.7 million and had cash and cash equivalents of$462.1 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 June 30, 2025, we had raised aggregate net proceeds of $687.8 million and had cash and cash equivalents of$436.6 million.

Previous wording

We have incurred operating losses in each year since our inception. Our net losses were$36.8 million and$12.5 million for the three months ended March 31, 2025 and 2024, respectively. As of March 31, 2025, we had an accumulated deficit of$257.9 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$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:

Previous wording

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 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.

Current wording

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.

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 and our sales of Series B and Series C redeemable convertible preferred stock in 2023.

Current 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.

Previous wording

The Company’s provision for income taxes is not material for the three months ended March 31, 2025 and 2024.

Current wording

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

Previous wording

The following table summarizes our results of operations for the three months ended March 31, 2025 and 2024.

Current wording

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

Previous wording

•approximately$4.9 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$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

Previous wording

•approximately$3.3 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$3.5 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.

Previous wording

General and administrative expenses increased by$4.1 million from $3.3 million for the three months ended March 31, 2024, to $7.5 million for the three months ended March 31, 2025. The following table summarizes our general and administrative expenses for the three months ended March 31, 2025 and 2024 (in thousands):

Current 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):

Previous wording

•approximately$2.4 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$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;

Previous wording

•approximately$1.0 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

Current 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

Previous wording

Interest income for the three months ended March 31, 2025 and 2024 was $5.0 million and $2.9 million, respectively. The increase was primarily due to significant increase in cash equivalents, as a result of proceeds from the sale of common stock and private sale ofredeemable convertible preferred stock.

Current 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.

Previous wording

•approximately$14.1 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$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;

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 March 31, 2025, we have received aggregate net proceeds of $687.7 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 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.

Previous wording

As of March 31, 2025, we had cash and cash equivalents of$462.1 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 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.

Previous wording

The following table sets forth a summary of the net cash flow activity for the three months ended March 31, 2025 and 2024 (in thousands):

Current 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):

Previous wording

For the three months ended March 31, 2025, net cash used in operating activities was$28.1 million resulting from our net loss of $36.8 million, partially offset by net increases in our operating assets and liabilities of $5.1 million and by non-cash charges of $3.6 million, consisting of stock-based compensation expense, depreciation and non-cash lease expense.

Current 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.

Previous wording

For the three months ended March 31, 2024, net cash used in operating activities was $14.6 million resulting from our net loss of $12.5 million andnet decrease in our operating assets and liabilities of $3.3 million, partially offset by non-cash charges of $1.2 million. Non-cash charges consisted of stock-based compensation expense, depreciation and non-cash lease charges.

Current 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.

Previous wording

Net cash provided by investing activities was $0.1 million for the three months ended March 31, 2024, due to proceeds from sales of equipment.

Current wording

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

Previous wording

Net cash provided by financing activities was $0.5 million and $0.1 million during the three months ended March 31, 2025 and 2024, respectively, consisting of proceeds from the exercise of stock options.

Current 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.