Bicara Therapeutics Inc.
For the period ended Mar 31, 2026. Filed May 11, 2026.
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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.
Mar 31, 2026 · Filed May 11, 2026
BCAX$8.65+5.6%Stored close · as of Nov 6, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious 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 OperationsCurrent report: 10-Q
Period ended 2026-03-31; filed 2026-05-11.
0001628280-26-033429
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsThe 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 114 previous paragraphs and 114 current paragraphs.
63 unchanged; 26 reworded; 24 added; 19 removed; 6 previous and 1 current paragraphs rearranged.
Tables are not compared: 7 previous and 4 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 (24)
Current report
We are a clinical-stage biopharmaceutical company committed to bringing transformative bifunctional therapies to patients with solid tumors. We have built a platform designed to facilitate the development of bifunctional therapies that precisely target the tumor and deliver a tumor-modulating payload to the tumor site. This dual-targeting approach both enhances drug exposure within the tumor microenvironment, or TME, and limits systemic toxicity. This approach was deployed in the development of our lead program ficerafusp alfa, formerly BCA101, a bifunctional epidermal growth factor receptor-, or EGFR, directed monoclonal antibody bound to a human transforming growth factor beta, or TGF-β, ligand trap.
Current report
By combining these two clinically validated targets, 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 TME. Ficerafusp alfa directs the TGF-β inhibitor into the immediate TME through the binding of EGFR on tumor cells, which we believe will drive the tumor penetration of immune cells that lead to deep and durable responses and an increase in overall survival.
Current report
We believe ficerafusp alfa has the potential to provide meaningful clinical benefit in solid tumors that are challenged by inadequate tumor penetration and where there is a strong biologic rationale for the dual inhibition of both EGFR and TGF-β, such as head and neck cancers and other squamous cell carcinomas which typically overexpress EGFR and TGF-β pathways. We are focusing our efforts and resources on the continued development of ficerafusp alfa in those tumor types for which there is strong biologic rationale and remaining unmet need for enhanced tumor penetration.
Current report
Corporate Highlights, Recent Progress and Key Upcoming Milestones
Current report
•FORTIFI-HN01 Phase 2/3 pivotal trial: We are currently conducting a global, randomized, double-blind, Phase 2/3 FORTIFI-HN01 pivotal trial evaluating 1500mg dosed once weekly, or QW, of ficerafusp alfa in combination with pembrolizumab in first-line, or 1L, recurrent/metastatic, or R/M, human papillomavirus infection, or HPV, -negative head and neck squamous cell carcinoma, or HNSCC, whose tumors express programmed death-ligand 1 with combined positive score, or CPS, of ≥1. In January 2026, we announced that 1500mg QW of ficerafusp alfa was selected as the optimal dose to bring forward in the Phase 3 portion of the FORTIFI-HN01 trial. In February 2026, the transition to the Phase 3 portion of the FORTIFI-HN01 trial was completed. The dose determination was informed by the open-label data sets from our Phase 1/1b trial, as well as data from the treatment arms of the Phase 2 portion of the FORTIFI-HN01 trial. The FORTIFI-HN01 will enroll approximately 650 patients, which we believe is sufficiently designed to achieve results to support potential approval by the U.S. Food and Drug Association, or the FDA. We enrolled the first patients in the FORTIFI-HN01 trial in February 2025. We expect to achieve substantial enrollment by the end of 2026 to enable an interim analysis in mid-2027 to support potential accelerated approval and U.S. launch in 2028.
Current report
•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 report
•Phase 1b expansion cohorts
Current report
◦1500mg QW, 750mg QW and 2000mg Q2W plus pembrolizumab in 1L R/M HPV-negative HNSCC: In May 2026, our peer-reviewed manuscript was published in the Journal of Clinical Oncology detailing results from the Phase 1b expansion cohort evaluating 1500mg of ficerafusp alfa QW in combination with pembrolizumab in 1L HPV-negative R/M HNSCC, most recently presented in an oral session at the 2025 American Society of Clinical Oncology, or ASCO, Annual Meeting. As of the March 20, 2025 data snapshot, the data demonstrated deep and durable responses with prolonged survival, evidenced by a median overall survival of 21.3 months, in patients with 1L HPV-negative R/M HNSCC. Additionally, the results suggest that ficerafusp alfa facilitated tumor penetration of immune cells by modulating EGFR/TGF-β in the tumor microenvironment. These findings support the potential of ficerafusp alfa as a well-tolerated, chemotherapy-free treatment option across the spectrum of disease burden, including patients with bulky or symptomatic disease, where rapid, meaningful responses would be particularly beneficial. At the upcoming 2026 ASCO Annual Meeting, we plan to present three-year follow-up data from the 1500mg QW cohort, which will allow us to characterize the long-term clinical benefit from this dose as compared to standard of care, and we will also share longer-term endpoints from the 750mg QW and 2000mg every-other-week, or Q2W, datasets.
Current report
◦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 report
◦1500mg QW plus pembrolizumab in 1L R/M HPV-positive smokers HNSCC: We are continuing to enroll an additional Phase 1b expansion cohort evaluating 1500mg QW of ficerafusp alfa in combination with pembrolizumab in patients with HPV-positive R/M HNSCC and a history of heavy smoking.
Current report
◦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 report
•Chief Medical Officer transition and appointment of Chief Commercial Officer: On May 8, 2026, Bill Schelman, M.D., Ph.D., previously our Executive Vice President, Clinical Development, succeeded David Raben, M.D. to serve as our Chief Medical Officer, and Dr. Raben has transitioned to serve as a Senior Executive Advisor to the Company. In addition, we have appointed Chris Sarchi as Chief Commercial Officer to lead our commercial organization in preparation for launch readiness.
Current report
•incur additional costs associated with being a public company.
Current report
Other (Expenses) Income
Current report
Interest Income
Current report
Other Comprehensive Loss
Current report
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 report
Research and development expenses increased by $13.2 million from $34.3 million for the three months ended March 31, 2025 to $47.5 million for the three months ended March 31, 2026.
Current report
Other Income
Current report
Interest income
Current report
“At-the-Market” Offering
Current report
February 2026 Offering
Current report
In February 2026, we issued and sold 8,581,250 shares of its common stock, including 1,406,250 shares pursuant to the exercise of the underwriters’ option to purchase additional shares, at a price to the public of $16.00 per share, and in lieu of common stock to certain investors, we sold pre-funded warrants to purchase 2,200,000 shares of common stock at a public offering price of $15.9999 per pre-funded warrant, which represents the per share public offering price of each share of common stock less the $0.0001 per share exercise price for each pre-funded warrant, or the February 2026 Offering. The February 2026 Offering closed on February 26, 2026 and resulted in net proceeds to us of approximately $161.8 million.
Current report
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.
Removed paragraphs (19)
Previous report
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 report
Phase 1/1b Clinical Trial Highlights
Previous 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%.
Previous 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.
Previous 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.
Previous report
•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.
Previous report
•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 report
Comparison of the nine months ended September 30, 2025 and 2024
Previous 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.
Previous report
The following table summarizes our research and development expenses for the nine months ended September 30, 2025 and 2024 (in thousands):
Previous 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:
Previous report
General and Administrative Expenses
Previous report
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 report
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 report
•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 report
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 report
Comparison of the Nine Months Ended September 30, 2025 and 2024
Previous 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.
Previous report
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.
Reworded paragraphs (26)
Previous 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.”
Current wording
The following discussion and analysis of our financial condition and results of operations 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
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.
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 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.
Previous 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:
Current 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:
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; and
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;
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.
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; and
Previous 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.
Current wording
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. 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, 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.
Previous wording
Interest income consists primarily of interest income earned on cash, cash equivalents and investments.
Current wording
Interest income consists primarily of interest income earned on cash, cash equivalents and marketable securities.
Previous wording
The Company’s provision for income taxes is not material for the three and nine months ended September 30, 2025 and 2024.
Current wording
The Company’s provision for income taxes is not material for the three months ended March 31, 2026 and 2025.
Previous 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;
Current 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;
Previous 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
Current 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
Previous 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.
Current 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.
Previous 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):
Current 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):
Previous 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;
Current 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
Previous 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
Current 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.
Previous 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.
Current 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.
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, 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.
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 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.
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 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 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.
Previous 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.
Current 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.
Previous 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):
Current 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):
Previous 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.
Current 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.
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 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.
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 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.
Previous wording
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 .
Current 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.
Previous 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.
Current 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.
Previous wording
This discussion and analysis of our financial condition and results of operations is based on our condensed consolidated financial statements, which we have prepared in accordance with GAAP. The preparation of our financial statements and related disclosures requires us to make estimates, assumptions and judgments that affect the reported amount of assets, liabilities, costs and expenses, and related disclosures. During the three months ended September 30, 2025, there were no material changes to our critical accounting policies and significant judgments described under Management’s Discussion and Analysis of Critical Accounting Policies and Significant Judgments which are included in our Annual Report on Form 10-K for the fiscal year ended December 31, 2024, or Form 10-K.
Current wording
This discussion and analysis of our financial condition and results of operations is based on our condensed consolidated financial statements, which we have prepared in accordance with GAAP. The preparation of our financial statements and related disclosures requires us to make estimates, assumptions and judgments that affect the reported amount of assets, liabilities, costs and expenses, and related disclosures. During the three months ended March 31, 2026, there were no material changes to our critical accounting policies and significant judgments described under Management’s Discussion and Analysis of Critical Accounting Policies and Significant Judgments which are included in our Annual Report on Form 10-K for the fiscal year ended December 31, 2025.
Previous wording
We may take advantage of these exemptions for up to five years or such earlier time that we are no longer an emerging growth company. We would cease to be an emerging growth company on the date that is the earliest of (i) the last day of the fiscal year in which we have total annual gross revenues of $1.235 billion or more; (ii) the last day of our fiscal year following the fifth anniversary of the date of the completion of our IPO; (iii) the date on which we have issued more than $1.0 billion in nonconvertible debt during the previous three years; or (iv) the date on which we are deemed to be a large accelerated filer under the rules of the SEC. We may choose to take advantage of some but not all of these exemptions. We have elected to avail ourselves of this exemption and, therefore, while we are an emerging growth company we will not be subject to new or revised accounting standards at the same time that they become applicable to other public companies that are not emerging growth companies. As a result of this election, our financial statements may not be comparable to those of other public companies that comply with new or revised accounting pronouncements as of public company effective dates. We may choose to early adopt any new or revised accounting standards whenever such early adoption is permitted for private companies.
Current wording
The Jumpstart Our Business Startups Act of 2012, or JOBS, permits an “emerging growth company” such as us to take advantage of an extended transition to comply with new or revised accounting standards applicable to public companies until those standards would otherwise apply to private companies. We have elected not to “opt out” of such extended transition period, which means that when a standard is issued or revised and it has different application dates for public or private companies, we will adopt the new or revised standard at the time private companies adopt the new or revised standard and will do so until such time that we either (i) irrevocably elect to “opt out” of such extended transition period or (ii) no longer qualify as an emerging growth company. We may choose to early adopt any new or revised accounting standards whenever such early adoption is permitted for private companies. There are other exemptions and reduced reporting requirements provided by the JOBS Act that we are currently evaluating. For example, as an “emerging growth company,” we are exempt from Sections 14A(a) and (b) of the Securities Exchange Act of 1934, as amended, which would otherwise require us to (1) submit certain executive compensation matters to shareholder advisory votes, such as “say-on-pay,” “say-on-frequency,” and “golden parachutes;” and (2) disclose certain executive compensation related items such as the correlation between executive compensation and performance and comparisons of our chief executive officer’s compensation to our median employee compensation. We also intend to rely on an exemption from the rule requiring us to provide an auditor’s attestation report on our internal controls over financial reporting pursuant to Section 404(b) of the Sarbanes-Oxley Act. We will continue to remain an “emerging growth company” until the earliest of the following: (1) the last day of the fiscal year following the fifth anniversary of the date of the completion of our IPO; (2) the last day of the fiscal year in which our total annual gross revenue is equal to or more than $1.235 billion; (3) the date on which we have issued more than $1 billion in nonconvertible debt during the previous three years; or (4) the date on which we are deemed to be a large accelerated filer under the rules of the SEC.
Previous wording
We are also a “smaller reporting company” as defined in the Securities Exchange Act of 1934, as amended. We may continue to be a smaller reporting company even after we are no longer an emerging growth company. We may take advantage of certain of the scaled disclosures available to smaller reporting companies and will be able to take advantage of these scaled disclosures for so long as the market value of our shares of common stock held by non-affiliates is less than $250.0 million measured on the last business day of our second fiscal quarter, or our annual revenue is less than $100.0 million during the most recently completed fiscal year and the market value of our shares of common stock held by non-affiliates is less than $700.0 million measured on the last business day of our second fiscal quarter.
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 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.
Rearranged current paragraphs (1)
Current report — wording carried from elsewhere
Comparison of the Three Months Ended March 31, 2026 and 2025
Rearranged previous paragraphs (6)
Previous report — wording carried elsewhere
•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 report — wording carried elsewhere
•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 report — wording carried elsewhere
The following table summarizes our results of operations for the nine months ended September 30, 2025 and 2024 (in thousands):
Previous report — wording carried elsewhere
Research and Development Expenses (including Research and Development—Related Party)
Previous report — wording carried elsewhere
•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 report — wording carried elsewhere
•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