Bicara Therapeutics Inc

Previous wording

You should read the following discussion and analysis of our financial condition and results of operations as of and for three and nine months ended September 30, 2024 and 2023, and related notes and other financial information included elsewhere in the previously filed prospectus and in conjunction with our audited consolidated financial statements. This discussion and analysis and other parts of this Form 10-Q 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 Form 10-Q. You should carefully read the “Risk Factors” section of this Form 10-Q 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.”

Current wording

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.”

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 intend to initiate a pivotal Phase 2/3 trial 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, late in the fourth quarter of 2024 or early in the first quarter of 2025.

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 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.

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 September 30, 2024, we had raised aggregate net proceeds of$686.5 million and had cash and cash equivalents of$520.8 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 March 31, 2025, we had raised aggregate net proceeds of$687.7 million and had cash and cash equivalents of$462.1 million.

Previous wording

We have incurred operating losses in each year since our inception. Our net losses were $47.0 million and $39.5 million for the nine months ended September 30, 2024 and 2023, respectively. As of September 30, 2024, we had an accumulated deficit of $200.1 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$36.8 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:

Previous wording

•ultimately establish a sales, marketing and distribution infrastructure to commercialize ficerafusp alfa or any future product candidates for which we may obtain marketing approval;

Current wording

•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

Previous wording

•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; and

Current wording

•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.

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 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, which will not be for at least the next several years, if ever. If we obtain regulatory approval for ficerafusp alfa or any of our 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 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.

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 bothour IPO in 2024 and from sales of Series B and 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 and our sales of Series B and Series C redeemable convertible preferred stock in 2023.

Previous wording

The Company’s provision for income taxes is not material for the three and nine months ended September 30, 2024 and 2023.

Current wording

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

Previous wording

•approximately $4.3 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$14.1 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;

Previous wording

•approximately $2.8 million in increased clinical operation and development cost, driven by costs associated with our pivotal Phase 2/3 clinical trial design and continued patient enrollment in our Phase 1/1b dose expansion cohorts; and

Current 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

Previous wording

•approximately $1.8 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$3.3 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.

Previous wording

General and administrative expenses increased by $2.2 million from $2.6 million for the three months ended September 30, 2023, to $4.8 million for the three months ended September 30, 2024. The following table summarizes our general and administrative expenses for the three months ended September 30, 2024 and 2023 (in thousands):

Current 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):

Previous wording

•approximately $1.8 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$2.4 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;

Previous wording

•approximately $0.2 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$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

Previous wording

•approximately $0.2 million in increased information technology expenses and related miscellaneous expenses.

Current wording

•approximately$0.7 million in increased information technology expenses and related miscellaneous expenses.

Previous wording

Interest income for the three months ended September 30, 2024 and 2023 was $3.1 million and $0.1 million, respectively. The increase was primarily due to significant increase in cash equivalents, as a result of proceeds from the IPO, Series B and Series C financings.

Current 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.

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 September 30, 2024, we have received aggregate net proceeds of $686.5 million from the sale of our redeemable convertible preferred stock in private placements, sale of common stock 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 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.

Previous wording

As of September 30, 2024, we had cash and cash equivalents of $520.8 million, which based upon our current operating plans, we believe 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 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.

Previous wording

The following table sets forth a summary of the net cash flow activity for the nine months ended September 30, 2024 and 2023 (in thousands):

Current 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):

Previous 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 and decreases in our operating assets and liabilities of $2.1 million, partially offset by non-cash charges of $4.5 million, consisting of stock-based compensation expense, depreciation and non-cash lease expense.

Current 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.

Previous wording

For the nine months ended September 30, 2023, net cash used in operating activities was $37.6 million resulting from our net loss of $39.5 million and net outflows in our operating assets and liabilities of $12.6 million, partially offset by non-cash charges of $14.5 million. Non-cash charges consisted of stock-based compensation expense, depreciation and changes in fair value of Series B preferred stock tranche rights liability.

Current 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.

Previous wording

Net cash provided by financing activities was $77.8 million during the nine months ended September 30, 2023, consisting of $77.7 million in net proceeds from the issuance of preferred stock and preferred stock tranche rights, in connection with Series B financing and $0.1 million in proceeds from the exercise of stock options.

Current 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.

Previous wording

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 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.

Current wording

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.

Previous wording

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 consolidated financial statements included elsewhere in this Form 10-Q.

Current wording

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 this Quarterly Report on Form 10-Q.