Bicara Therapeutics Inc.

Previous wording

•Alternate dose study to evaluate loading and every-three-week maintenance regimen: In February 2026, we presented positive data from the Phase 1b expansion cohort evaluating 2000mg of ficerafusp alfa every-other-week in combination with pembrolizumab in 1L HPV-negative R/M HNSCC at the 2026 Multidisciplinary Head and Neck Cancers Symposium and our plans to develop an alternate dosing regimen to potentially expand optionality for patients and providers. Based on recent discussions with the FDA, we plan to initiate a randomized clinical study that will evaluate ficerafusp alfa in combination with pembrolizumab, administered as a 12-week loading dose of 1500mg QW followed by maintenance dosing of 2250mg every three weeks. We expect to initiate the study in the third quarter of 2026 to have results in time for potential U.S. accelerated approval.

Current wording

•Alternate dose study to evaluate loading and every-three-week maintenance regimen: In August 2026, we announced the initiation of FORTIFI-FLEX, a randomized clinical study that will evaluate ficerafusp alfa in combination with pembrolizumab, administered as a 12-week loading dose of 1500mg QW followed by maintenance dosing of 2250mg every three weeks. We expect to have results from this study by the time of potential U.S. accelerated approval in 1L R/M HPV-negative HNSCC. This builds on positive data we presented in February 2026 from the Phase 1b expansion cohort evaluating 2000mg of ficerafusp alfa every-other-week in combination with pembrolizumab in 1L R/M HPV-negative HNSCC at the 2026 Multidisciplinary Head and Neck Cancers Symposium, which supported our plans to develop an alternate dosing regimen to expand optionality for patients and providers.

Previous wording

◦1500mg QW plus pembrolizumab in 1L R/M HPV-negative HNSCC with CPS<1: We are continuing to enroll a Phase 1b expansion cohort evaluating 1500mg QW of ficerafusp alfa in combination with pembrolizumab in patients with 1L HPV-negative R/M HNSCC with a CPS<1.

Current wording

◦1500mg QW plus pembrolizumab in 1L R/M HPV-negative HNSCC with CPS<1: We are continuing to enroll a Phase 1b expansion cohort evaluating 1500mg QW of ficerafusp alfa in combination with pembrolizumab in patients with 1L R/M HPV-negative HNSCC with a CPS<1.

Previous wording

◦1500mg QW plus pembrolizumab in other solid tumors: We are continuing to enroll Phase 1b expansion cohorts evaluating 1500mg QW of ficerafusp alfa both as monotherapy and in combination with pembrolizumab in patients with third-line metastatic colorectal cancer with microsatellite stable RAS/BRAF wild-type. We expect to present data from these cohorts in the second half of 2026.

Current wording

◦1500mg QW in other solid tumors: We are continuing to enroll Phase 1b expansion cohorts evaluating 1500mg QW of ficerafusp alfa both as monotherapy and in combination with pembrolizumab in patients with third-line metastatic colorectal cancer with microsatellite stable RAS/BRAF wild-type. We expect to present data from these cohorts in the second half of 2026. In 2025, we presented data from additional Phase 1b cohorts evaluating ficerafusp alfa monotherapy in patients with second-line or later cutaneous squamous cell carcinoma, as well as ficerafusp alfa in combination with pembrolizumab in patients with second-line or later squamous cancer of the anal canal. These data demonstrated proof-of-concept in both indications and reinforced our conviction in ficerafusp alfa's broad applicability across TGF-β-driven tumors.

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 sale of common stock in connection with our initial public offering, or IPO, ATM Program (as defined below), our February 2026 Offering (as defined below), exercise of stock options, private placements of our redeemable convertible preferred stock, and through debt financing. As of March 31, 2026, we had raised aggregate net proceeds of$882.9 million and had cash, cash equivalents and marketable securities of$539.8 million. The February 2026 Offering closed on February 26, 2026 and resulted in net proceeds to us of approximately $161.8 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 sale of common stock in connection with our initial public offering, or IPO, ATM Program (as defined below), our February 2026 Offering (as defined below), exercise of stock options, private placements of our redeemable convertible preferred stock, and through debt financing. As of June 30, 2026, we had raised aggregate net proceeds of$885.3 million and had cash, cash equivalents and marketable securities of$497.3 million. The February 2026 Offering closed on February 26, 2026 and resulted in net proceeds to us of approximately $161.8 million.

Previous wording

We have incurred operating losses in each year since our inception. Our net losses were$56.2 million and$36.8 million for the three months ended March 31, 2026 and 2025, respectively. As of March 31, 2026, we had an accumulated deficit of$415.2 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$55.4 million and$27.4 million for the three months ended June 30, 2026 and 2025, respectively and$111.6 million and$64.2 million for the six months ended June 30, 2026 and 2025, respectively. As of June 30, 2026, we had an accumulated deficit of $470.6 million. We expect our expenses and operating losses will increase substantially as we:

Previous wording

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.

Current wording

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 due to the 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.

Previous wording

The Company’s provision for income taxes is not material for the three months ended March 31, 2026 and 2025.

Current wording

The Company’s provision for income taxes is not material for the three and six months ended June 30, 2026 and 2025.

Previous wording

During the three months ended March 31, 2026, the Company held marketable securities in U.S. Treasury Bills. The unrealized loss on these instruments was recorded in Other Comprehensive Loss.

Current wording

During the three and six months ended June 30, 2026, the Company held marketable securities in U.S. Treasury Bills. The unrealized loss on these instruments was recorded in Other Comprehensive Loss.

Previous wording

•approximately$4.5 million in increased clinical operation and development cost, driven by costs associated with our Phase 2/3 FORTIFI-HN01 pivotal trial and continued patient enrollment in our ongoing Phase 1/1b trials; and

Current wording

•approximately $10.9 million in increased clinical operation and development cost, driven by costs associated with our Phase 2/3 FORTIFI-HN01 pivotal trial and continued patient enrollment in our ongoing Phase 1/1b trials; and

Previous wording

•approximately$4.0 million in increased personnel related costs, including stock-based compensation, driven by higher number and value of stock options granted and 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 $6.9 million in increased personnel related costs, including stock-based compensation, driven by higher number and value of stock options granted and 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$5.3 million from $7.5 million for the three months ended March 31, 2025 to $12.7 million for the three months ended March 31, 2026. The following table summarizes our general and administrative expenses for the three months ended March 31, 2026 and 2025 (in thousands):

Current wording

General and administrative expenses increased by$7.0 million from $7.2 million for the three months ended June 30, 2025 to $14.2 million for the three months ended June 30, 2026. The following table summarizes our general and administrative expenses for the six months ended June 30, 2026 and 2025 (in thousands):

Previous wording

•approximately$3.1 million in increased personnel related costs, including stock-based compensation, driven by an increase in the size of our workforce and by a higher number and value of stock options granted; and

Current wording

•approximately $4.0 million in increased personnel related costs, including stock-based compensation, driven by an increase in the size of our workforce and by a higher number and value of stock options granted; and

Previous wording

•approximately$2.1 million in increased professional service expenses associated with higher legal, accounting and other expenses as we continue to build out our general and administrative functions to support advancing of our clinical trials.

Current wording

•approximately $3.3 million in increased professional service expenses associated with higher legal, accounting, commercial and other expenses as we continue to build out our general and administrative functions to support advancement of our clinical trials and prepare for potential commercial launch.

Previous wording

Interest income for the three months ended March 31, 2026 and 2025 was $4.1 million and $5.0 million, respectively. The decrease was primarily due to a lower average balance in cash, cash equivalents and marketable securities.

Current wording

Interest income for the three months ended June 30, 2026 and 2025 was $4.6 million and $4.7 million, respectively. The decrease was primarily due to lower interest rates.

Previous wording

•approximately $4.6 million in increased manufacturing cost, driven by additional batch manufacturing of drug substance in connection with our Phase 2/3 FORTIFI-HN01 pivotal trial and Phase 1/1b clinical trial;

Current wording

•approximately $7.4 million in increased manufacturing and process development cost, driven by additional batch manufacturing of drug substance in connection with our Phase 2/3 FORTIFI-HN01 pivotal trial and Phase 1/1b clinical trial and cost to purchase pembrolizumab in connection with our Phase 2/3 FORTIFI-HN01 pivotal 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. Further we expect to incur additional costs associated with operating as a public company. From our inception in December 2018 through March 31, 2026, we have received aggregate net proceeds of $882.9 million from the sale of our common stock in the IPO, ATM Program and the February 2026 Offering, the exercise of stock options, and sale of 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. Further, we expect to incur additional costs associated with operating as a public company. From our inception in December 2018 through June 30, 2026, we have received aggregate net proceeds of $885.3 million from the sale of our common stock in the IPO, ATM Program and the February 2026 Offering, the exercise of stock options, and sale of redeemable convertible preferred stock in private placements and debt financing.

Previous wording

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 was declared effective by the SEC on November 26, 2025. 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. 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. During the quarter ended March 31, 2026, there were no sales of our common stock through the ATM Program. As of March 31, 2026, a total of 1,604,000 shares of our common stock had been sold through the ATM Program, resulting in net proceeds to us of $29.5 million.

Current wording

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 was declared effective by the SEC on November 26, 2025. 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. 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. During the three and six months ended June 30, 2026, there were no sales of our common stock through the ATM Program. As of June 30, 2026, a total of 1,604,000 shares of our common stock had been sold through the ATM Program, resulting in net proceeds to us of $29.5 million.

Previous wording

As of March 31, 2026, we had cash, cash equivalents and marketable securitiesof$539.8 million. Based upon our current operating plans, we believe that our existing cash, cash equivalents and marketable securities will be sufficient to fund our operations and capital expenditure requirements 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, 2026, we had cash, cash equivalents and marketable securitiesof$497.3 million. Based upon our current operating plans, we believe that our existing cash, cash equivalents and marketable securities will be sufficient to fund our operations and capital expenditure requirements 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, 2026 and 2025 (in thousands):

Current wording

The following table sets forth a summary of the net cash flow activity for the six months ended June 30, 2026 and 2025 (in thousands):

Previous wording

For the three months ended March 31, 2026, net cash used in operating activities was$37.5 million resulting from our net loss of$56.2 million, partially offset by net increases in our operating assets and liabilities of $12.2 million and by non-cash charges of $6.5 million, consisting of stock-based compensation expense, depreciation and non-cash lease expense.

Current wording

For the six months ended June 30, 2026, net cash used in operating activities was $81.7 million resulting from our net loss of $111.6 million, partially offset by net increases in our operating assets and liabilities of $14.6 million and by non-cash charges of $15.3 million, consisting of stock-based compensation expense, depreciation and non-cash lease expense.

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 andnet decrease in our operating assets and liabilities of $5.1 million, partially offset by non-cash charges of $3.6 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, 2025, net cash used in operating activities was $53.7 million resulting from our net loss of $64.2 million, partially offset bynet increase in our operating assets and liabilities of $3.2 million and non-cash charges of $7.3 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 $100.9 million for the three months ended March 31, 2026 and immaterial for March 31, 2025. The increase in cash provided by investing activities is due to proceeds from maturity of marketable securities in 2026, which were purchased in the third quarter of 2025.

Current wording

Net cash used in investing activities was $84.0 million for the six months ended June 30, 2026, resulting from cash used to purchase $244.9 million marketable securities, partially offset by proceeds from maturity of marketable securities in 2026 totaling $161.0 million, which were purchased in the third quarter of 2025.

Previous wording

Net cash provided by financing activities was$163.3 million for the three months ended March 31, 2026, consisting primarily of proceeds from the offering of common stock and pre-funded warrants in February 2026 and proceeds from the exercise of stock options.

Current wording

Net cash provided by financing activities was $165.7 million for the six months ended June 30, 2026, consisting primarily of proceeds from the offering of common stock and pre-funded warrants in February 2026 and proceeds from the exercise of stock options.

Previous wording

Net cash provided by financing activities was $0.5 million for the three months ended March 31, 2025, consisting primarily of proceeds from the exercise of common stock options.

Current wording

Net cash provided by financing activities was $0.6 million for the six months ended June 30, 2025, consisting primarily of proceeds from the exercise of common stock options.

Previous wording

We are also a “smaller reporting company” as defined in the Exchange Act. 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 until for so long as either (i) our voting and non-voting common stock held by non-affiliates is less than $250.0 million measured on the last business day of our second fiscal quarter, or (ii) our annual revenue is less than $100.0 million during the most recently completed fiscal year and our voting and non-voting common stock held by non-affiliates is less than $700.0 million measured on the last business day of our second fiscal quarter.

Current wording

We are also a “smaller reporting company” as defined in the Exchange Act. 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 for so long as either (i) our voting and non-voting common stock held by non-affiliates is less than $250.0 million measured on the last business day of our second fiscal quarter, or (ii) our annual revenue is less than $100.0 million during the most recently completed fiscal year and our voting and non-voting common stock held by non-affiliates is less than $700.0 million measured on the last business day of our second fiscal quarter.