Celldex Therapeutics, Inc.

Previous wording

During the past five years through December 31, 2025, we incurred an aggregate of $662.2 million in research and development expenses. The following table indicates the amount incurred for each of our significant research programs and for other identified research and development activities during the six months ended June 30, 2026 and 2025. The amounts disclosed in the following table reflect direct research and development costs and an allocation of indirect research and development costs to each program.

Current wording

During the past five years through December 31, 2025, we incurred an aggregate of $662.2 million in research and development expenses. The following table indicates the amount incurred for each of our significant research programs and for other identified research and development activities during the nine months ended September 30, 2026 and 2025. The amounts disclosed in the following table reflect direct research and development costs and an allocation of indirect research and development costs to each program.

Previous wording

Chronic Spontaneous Urticaria (CSU) Summary of Phase 1 and Phase 2 Data

Current wording

Chronic Spontaneous Urticaria (CSU) Summary of Phase 1, Phase 2, and Phase 3 Data

Previous wording

Barzolvolimab uniquely targets the root cause of CSU—the mast cell. Based on results from completed Phase 1 and Phase 2 studies in CSU, barzolvolimab has the potential to offer symptom free complete control (absence of itch and hives, UAS7=0) and clinically meaningful improvements in quality of life and angioedema in a majority of patients.

Current wording

Barzolvolimab uniquely targets the root cause of CSU—the mast cell. Based on results from completed Phase 1 and Phase 2 studies and the topline data from both ongoing Phase 3 trials in CSU (Q4W dosing), barzolvolimab has the potential to offer symptom free complete control (absence of itch and hives, UAS7=0) and clinically meaningful improvements in quality of life and angioedema in a majority of patients.

Previous wording

During post-treatment follow up, 71% (10 of 14) of patients who had been treated with doses greater than or equal to 1.5 mg/kg and had a complete response (UAS7=0) at Week 12, remained urticaria free at Week 24 (patients received last dose of barzolvolimab at Week 8). Profound and durable improvement in angioedema symptoms as measured through the weekly angioedema activity score (AAS7) was achieved across all dose levels evaluated with sustained activity observed with the 1.5 mg/kg and greater dose levels. Patients also reported improvements in quality of life outcomes as assessed by the Dermatology Life Quality Index (DLQI) which surveys patients’ perceptions of symptoms and feelings, daily activities, leisure, work and school performance, personal relationships and treatment.

Current wording

We have completed a Phase 1b randomized, double-blind, placebo-controlled multi-center study of barzolvolimab in CSU. The study was designed to assess the safety of multiple ascending doses of barzolvolimab in patients with CSU who remain symptomatic despite treatment with antihistamines. In the study and in post-treatment follow-up, barzolvolimab resulted in rapid, marked, and durable responses, and demonstrated prolonged disease control. Results were consistent in patients with prior omalizumab therapy experience. Profound and durable improvement in angioedema symptoms as measured through the weekly angioedema activity score (AAS7) was achieved across all dose levels evaluated with sustained activity observed with the 1.5 mg/kg and greater dose levels. Patients also reported improvements in quality of life outcomes as assessed by the Dermatology Life Quality Index (DLQI) which surveys patients’ perceptions of symptoms and feelings, daily activities, leisure, work and school performance, personal relationships and treatment. Tryptase suppression, indicative of mast cell depletion, paralleled symptom improvement, demonstrating the impact of mast cell depletion on CSU disease activity. Barzolvolimab was well tolerated. Most adverse events were mild or moderate in severity and resolved while on study.

Previous wording

Topline data from this study were presented in November of 2023 and 12 week treatment results were presented at the AAAAI Annual Meeting in February 2024. Data from the 208 patients randomized in the study showed that barzolvolimab achieved the primary efficacy endpoint, with a statistically significant mean change from baseline to Week 12 in UAS7 compared to placebo at all dose levels. Secondary and exploratory endpoints in the study were also achieved at Week 12 and strongly support the primary endpoint results, including changes in ISS7 and HSS7 and responder analyses. Importantly, barzolvolimab demonstrated rapid, durable and clinically meaningful responses in patients with moderate to severe CSU refractory to antihistamines, including patients with prior omalizumab treatment. Demographics and baseline disease characteristics were well balanced across treatment groups. The majority of patients on study had severe disease (UAS7≥28).

Current wording

Topline data from this study were presented in November 2023 and 12 week treatment results were presented at the AAAAI Annual Meeting in February 2024. Data from the 208 patients randomized in the study showed that barzolvolimab achieved the primary efficacy endpoint, with a statistically significant mean change from baseline to Week 12 in UAS7 compared to placebo at all dose levels. Secondary and exploratory endpoints in the study were also achieved at Week 12 and strongly support the primary endpoint results, including changes in ISS7 and HSS7 and responder analyses. Importantly, barzolvolimab demonstrated rapid, durable and clinically meaningful responses in patients with moderate to severe CSU refractory to antihistamines, including patients with prior omalizumab treatment. Demographics and baseline disease characteristics were well balanced across treatment groups. The majority of patients on study had severe disease (UAS7≥28).

Previous wording

In June of 2025, 52 week data on angioedema activity and additional measures of angioedema control were presented at the EAACI 2025 Congress. Barzolvolimab continued to demonstrate robust, durable and deepening improvements in angioedema symptoms over the treatment period.

Current wording

In June 2025, 52 week data on angioedema activity and additional measures of angioedema control were presented at the EAACI 2025 Congress. Barzolvolimab continued to demonstrate robust, durable and deepening improvements in angioedema symptoms over the treatment period.

Previous wording

In June of 2025, long term follow up data from the Phase 2 CSU study were presented at the EAACI 2025 Congress. At Week 76, seven months after receiving their final dose of barzolvolimab, patients continued to experience profound clinical benefit on study. Key highlights included:

Current wording

In June 2025, long term follow up data from the Phase 2 CSU study were presented at the EAACI 2025 Congress. At Week 76, seven months after receiving their final dose of barzolvolimab, patients continued to experience profound clinical benefit on study. Key highlights included:

Previous wording

In July 2024, we initiated two Phase 3 studies of barzolvolimab in CSU. The studies, EMBARQ-CSU1 and EMBARQ-CSU2, are designed to establish the efficacy and safety of barzolvolimab in adult patients with CSU who remain symptomatic despite H1 antihistamine treatment. 1,939 patients were enrolled—the largest program conducted in antihistamine refractory CSU, including patients with advanced therapy experienced/refractory CSU. The studies included 43 countries and over 500 sites. Both Phase 3 trials are randomized, double-blind, placebo-controlled, parallel group, global studies where patients have been randomized evenly per trial to barzolvolimab 150 mg every 4 weeks (following 300 mg loading dose), barzolvolimab 300 mg every 8 weeks (following 450 mg loading dose) or placebo for 52 weeks. At 24 weeks, patients on placebo are re-randomized to active treatment across both dosing groups. After completion of the 52 week treatment period, patients on study are followed for 16 weeks. The primary endpoint of the studies will evaluate the clinical effect of barzolvolimab in reducing urticaria activity (weekly urticaria activity score; UAS7) at Week 12. The studies are designed to detect a clinically meaningful difference between each of the active arms versus placebo in the overall population as well as in the subpopulation of omalizumab refractory participants. The primary endpoint analysis will be performed when all patients have completed the placebo controlled portion of the study at 24 weeks. Enrollment to the studies was completed in February 2026 and topline data will be available in September/October 2026. Assuming positive Phase 3 data, the Company plans to file a BLA in 2027.

Current wording

In July 2024, we initiated two Phase 3 studies of barzolvolimab in CSU. The studies, EMBARQ-CSU1 and EMBARQ-CSU2, are designed to establish the efficacy and safety of barzolvolimab in adult patients with CSU who remain symptomatic despite H1 antihistamine treatment. 1,939 patients were enrolled—the largest program conducted in antihistamine refractory CSU, including patients with advanced therapy experienced/refractory CSU. The studies included 43 countries and over 500 sites. Both Phase 3 trials are randomized, double-blind, placebo-controlled, parallel group, global studies where patients have been randomized evenly per trial to barzolvolimab 150 mg every 4 weeks (following 300 mg loading dose), barzolvolimab 300 mg every 8 weeks (following 450 mg loading dose) or placebo for 52 weeks. At 24 weeks, patients on placebo are re-randomized to active treatment across both dosing groups. After completion of the 52 week treatment period, patients on study are followed for 16 weeks. The primary endpoint of the studies evaluates the clinical effect of barzolvolimab in reducing urticaria activity (weekly urticaria activity score; UAS7) at Week 12. The studies are designed to detect a clinically meaningful difference between each of the active arms versus placebo in the overall population as well as in the subpopulation of omalizumab refractory participants. The primary endpoint analysis was performed after all patients completed the placebo controlled portion of the study at 24 weeks.

Previous wording

We completed a Phase 2 study in patients with CIndU who remain symptomatic despite antihistamine therapy. The study was conducted at approximately 85 sites across approximately 12 countries. The randomized, double-blind, placebo-controlled, parallel group Phase 2 study evaluated the efficacy and safety profile of multiple dose regimens of barzolvolimab in patients with CIndU to determine the optimal dosing strategy. 196 patients in 2 cohorts (differentiated by CIndU subtype) including 97 patients with cold urticaria and 99 patients with symptomatic dermographism were randomly assigned on a 1:1:1 ratio to receive subcutaneous injections of barzolvolimab at 150 mg every 4 weeks, 300 mg every 8 weeks or placebo during a 20-week treatment phase. Patients then entered a follow-up phase for an additional 24 weeks. In addition, the study included the option for patients who had symptoms following the treatment phase, including patients who were on placebo, to enroll in an open label extension where all patients received 300 mg of barzolvolimab every 8 weeks. The primary endpoint of the study was the percentage of patients with a negative provocation test at Week 12. Secondary endpoints included safety and other assessments of clinical activity including CTT (Critical Temperature Threshold), CFT (Critical Friction Threshold) and WI-NRS (Worst itch numeric rating scale).

Current wording

urticaria and 99 patients with symptomatic dermographism were randomly assigned on a 1:1:1 ratio to receive subcutaneous injections of barzolvolimab at 150 mg every 4 weeks, 300 mg every 8 weeks or placebo during a 20-week treatment phase. Patients then entered a follow-up phase for an additional 24 weeks. In addition, the study included the option for patients who had symptoms following the treatment phase, including patients who were on placebo, to enroll in an open label extension where all patients received 300 mg of barzolvolimab every 8 weeks. The primary endpoint of the study was the percentage of patients with a negative provocation test at Week 12. Secondary endpoints included safety and other assessments of clinical activity including CTT (Critical Temperature Threshold), CFT (Critical Friction Threshold) and WI-NRS (Worst itch numeric rating scale).

Previous wording

In December of 2024, we announced the initiation of a Phase 2 study in atopic dermatitis (AD). AD is one of the most common chronic inflammatory skin diseases, with a lifetime prevalence of up to 20% of the US population and a substantial impact on quality of life (Kawakami, et al. 2009). Mast cells are strongly implicated in all facets of AD pathophysiology and the fundamental processes that characterize AD, including epithelial barrier dysfunction, immune cell recruitment, neuroinflammation (Keith, et al. 2023) and multiple other mast cell-associated factors that correlate with disease severity. Activated mast cells are also found in increased numbers in lesional biopsies. Two-thirds of patients treated with first line systemic therapy (1.7 million patients in the US) do not achieve complete control of their atopic dermatitis (Simpson, Bieber, Guttman-Yassky, et al. 2016) and new therapies that offer rapid, meaningful relief from the severe itching and breakdown of the skin associated with AD are needed. Given barzolvolimab’s potential as a mast cell depleting agent, we believe AD is an important indication for future study.

Current wording

In December 2024, we announced the initiation of a Phase 2 study in atopic dermatitis (AD). AD is one of the most common chronic inflammatory skin diseases, with a lifetime prevalence of up to 20% of the US population and a substantial impact on quality of life (Kawakami, et al. 2009). Mast cells are strongly implicated in all facets of AD pathophysiology and the fundamental processes that characterize AD, including epithelial barrier dysfunction, immune cell recruitment, neuroinflammation (Keith, et al. 2023) and multiple other mast cell-associated factors that correlate with disease severity. Activated mast cells are also found in increased numbers in lesional biopsies. Two-thirds of patients treated with first line systemic therapy (1.7 million patients in the US) do not achieve complete control of their atopic dermatitis (Simpson, Bieber, Guttman-Yassky, et al. 2016) and new therapies that offer rapid, meaningful relief from the severe itching and breakdown of the skin associated with AD are needed. Given barzolvolimab’s potential as a mast cell depleting agent, we believe AD is an important indication for future study.

Previous wording

The barzolvolimab manufacturing process has been successfully transferred and scaled up to produce larger cGMP batches at both Drug Substance (DS) and Drug Product (DP) commercial Contract Development and Manufacturing Organizations in support of late-stage trials and to prepare for potential commercialization. Drug product manufacturing into 1 mL pre-filled syringes has been completed and pre-filled syringes are actively being used in Phase 3 trials. In 2025, we initiated the Process Performance Qualification (PPQ) manufacturing runs for DS and anticipate the completion of those activities in 2026. We are currently preparing for the DP PPQ activities and expect to complete these activities in 2026.

Current wording

The barzolvolimab manufacturing process has been successfully transferred and scaled up to produce larger cGMP batches at both Drug Substance (DS) and Drug Product (DP) commercial Contract Development and Manufacturing Organizations in support of late-stage trials and to prepare for potential commercialization. Drug product manufacturing into 1 mL pre-filled syringes has been completed and pre-filled syringes are actively being used in Phase 3 trials. In 2025, we initiated the Process Performance Qualification (PPQ) manufacturing runs for DS and anticipate the completion of those activities in 2026. DP PPQ activities were successfully completed.

Previous wording

In November 2024, we initiated a multi-part Phase 1 study of CDX-622 in healthy volunteers and enrollment was completed across all parts in January 2026. The Phase 1a clinical trial is a three-part, randomized, double-blind, placebo-controlled, dose escalation study designed to assess the safety, pharmacokinetics, and pharmacodynamics of CDX-622 in up to 80 healthy participants. A single dose of CDX-622 or placebo was administered intravenously (IV) once during Part 1. In Part 2, CDX-622 or placebo was administered IV every 2 weeks (Q2W) for up to 6 weeks following the first dose, for a total of 4 doses. In Part 3, a single dose of CDX-622 or placebo was administered subcutaneously once. Participants are followed for 12 weeks in all Parts following the last dose of study drug. The pharmacodynamic biomarkers from blood and skin will be highly informative on the ability of CDX-622 to engage and neutralize SCF and TSLP.

Current wording

A single dose of CDX-622 or placebo was administered intravenously (IV) once during Part 1. In Part 2, CDX-622 or placebo was administered IV every 2 weeks (Q2W) for up to 6 weeks following the first dose, for a total of 4 doses. In Part 3, a single dose of CDX-622 or placebo was administered subcutaneously once. Participants are followed for 12 weeks in all Parts following the last dose of study drug. The pharmacodynamic biomarkers from blood and skin will be highly informative on the ability of CDX-622 to engage and neutralize SCF and TSLP.

Previous wording

See Note 2 to the unaudited condensed consolidated financial statements included elsewhere in this Quarterly Report on Form 10-Q for information regarding newly adopted and recent accounting pronouncements. See also Note 2 to our financial statements included in our Annual Report on Form 10-K for the year ended December 31, 2025 for a discussion of our critical accounting policies and estimates. There have been no material changes to such critical accounting policies or estimates. We believe our most critical accounting policies include accounting for contingent consideration, revenue recognition, intangible and long-lived assets, research and development expenses and stock-based compensation expense.

Current wording

See Note 2 to the unaudited condensed consolidated financial statements included elsewhere in this Quarterly Report on Form 10-Q for information regarding newly adopted and recent accounting pronouncements. See also Note 2 to our financial statements included in our Annual Report on Form 10-K for the year ended December 31, 2025 for a discussion of our critical accounting policies and estimates. There have been no material changes to such critical accounting policies or estimates. We believe

Previous wording

The $16.9 million increase in net loss for the three months ended June 30, 2026, as compared to the three months ended June 30, 2025, was primarily due to an increase in research and development expenses related to barzolvolimab.

Current wording

The $8.5 million increase in net loss for the three months ended September 30, 2026, as compared to the three months ended September 30, 2025, was primarily due to an increase in research and development expenses related to barzolvolimab and an increase in general and administrative expenses.

Previous wording

The $0.7 million decrease in contracts and grants revenue for the three months ended June 30, 2026, as compared to the three months ended June 30, 2025, was primarily due to a decrease in revenue from our contract manufacturing and research and development agreements with Rockefeller University. We expect revenue to increase over the next twelve months as a result of an increase in services expected to be performed under our contract manufacturing and research and development agreements with Rockefeller University, although there may be fluctuations on a quarterly basis.

Current wording

No revenue was recorded for the three months ended September 30, 2026 and 2025. We expect revenue to increase over the next twelve months as a result of an increase in services expected to be performed under our contract manufacturing and research and development agreements with Rockefeller University, although there may be fluctuations on a quarterly basis.

Previous wording

Personnel expenses primarily include salary, benefits, stock-based compensation and payroll taxes. The $1.8 million increase in personnel expenses for the three months ended June 30, 2026, as compared to the three months ended June 30, 2025, was primarily due to an increase in employee headcount. We expect personnel expenses to increase over the next twelve months as a result of additional headcount to support the development of barzolvolimab.

Current wording

Personnel expenses primarily include salary, benefits, stock-based compensation and payroll taxes. The $3.8 million increase in personnel expenses for the three months ended September 30, 2026, as compared to the three months ended September 30, 2025, was primarily due to an increase in employee headcount. We expect personnel expenses to increase over the next twelve months as a result of additional headcount to support the development of barzolvolimab.

Previous wording

Laboratory supplies expenses include laboratory materials and supplies, services, and other related expenses incurred in the development of our technology. The $1.0 million increase in laboratory supply expenses for the three months ended June 30, 2026, as compared to the three months ended June 30, 2025, was primarily due to higher laboratory materials and supplies purchases. We expect laboratory supplies expenses to remain relatively consistent over the next twelve months, although there may be fluctuations on a quarterly basis.

Current wording

Laboratory supplies expenses include laboratory materials and supplies, services, and other related expenses incurred in the development of our technology. The $1.1 million increase in laboratory supply expenses for the three months ended September 30, 2026, as compared to the three months ended September 30, 2025, was primarily due to higher laboratory materials and supplies purchases. We expect laboratory supplies expenses to remain relatively consistent over the next twelve months, although there may be fluctuations on a quarterly basis.

Previous wording

Facility expenses include depreciation, amortization, utilities, rent, maintenance and other related expenses incurred at our facilities. The $0.2 million decrease in facility expenses for the three months ended June 30, 2026, as compared to the three months ended June 30, 2025, was primarily due to lower expense related to our leased facilities. In 2025, we signed a new lease in New Haven, Connecticut and we are in process of relocating our existing New Haven operations to that facility. In addition, we expanded our leased space in Hampton, New Jersey in June 2026. As a result, we expect facility expenses to increase over the next twelve months, although there may be fluctuations on a quarterly basis.

Current wording

Facility expenses include depreciation, amortization, utilities, rent, maintenance and other related expenses incurred at our facilities. Facility expenses for the three months ended September 30, 2026 were relatively consistent with the three months ended September 30, 2025. We expect facility expenses to increase over the next twelve months as a result of our new lease in New Haven, Connecticut and the expansion of our space in Hampton, New Jersey, although there may be fluctuations on a quarterly basis.

Previous wording

Product development expenses include clinical investigator site fees, external trial monitoring costs, data accumulation costs, contracted research and outside clinical drug product manufacturing. The $8.2 million increase in product development expenses for the three months ended June 30, 2026, as compared to the three months ended June 30, 2025, was primarily due to an increase in barzolvolimab clinical trial expenses. We expect product development expenses to increase over the next twelve months primarily due to increased costs associated with the development of barzolvolimab, although there may be fluctuations on a quarterly basis.

Current wording

Product development expenses include clinical investigator site fees, external trial monitoring costs, data accumulation costs, contracted research and outside clinical drug product manufacturing. The $4.0 million decrease in product development expenses for the three months ended September 30, 2026, as compared to the three months ended September 30, 2025, was primarily due to a decrease in contract manufacturing expenses. We expect product development expenses to increase over the next twelve months primarily due to increased costs associated with the development of barzolvolimab, although there may be fluctuations on a quarterly basis.

Previous wording

The $2.7 million increase in general and administrative expenses for the three months ended June 30, 2026, as compared to the three months ended June 30, 2025, was primarily due to higher commercial planning expenses and an increase in employee headcount. We expect general and administrative expenses to increase over the next twelve months primarily due to increased costs to support commercial planning efforts and the continued growth of our organization in preparation for potential commercialization of barzolvolimab, although there may be fluctuations on a quarterly basis.

Current wording

The $4.2 million increase in general and administrative expenses for the three months ended September 30, 2026, as compared to the three months ended September 30, 2025, was primarily due to higher commercial planning expenses and an increase in employee headcount. We expect general and administrative expenses to increase over the next twelve months primarily due to increased costs to support commercial planning efforts and the continued growth of our organization in preparation for potential commercialization of barzolvolimab, although there may be fluctuations on a quarterly basis.

Previous wording

The $41.8 million increase in net loss for the six months ended June 30, 2026, as compared to the six months ended June 30, 2025, was primarily due to an increase in research and development expenses related to barzolvolimab.

Current wording

The $50.3 million increase in net loss for the nine months ended September 30, 2026, as compared to the nine months ended September 30, 2025, was primarily due to an increase in research and development expenses related to barzolvolimab and an increase in general and administrative expenses.

Previous wording

The $1.3 million decrease in contracts and grants revenue for the six months ended June 30, 2026, as compared to the six months ended June 30, 2025, was primarily due to a decrease in revenue from our contract manufacturing and research and development agreements with Rockefeller University.

Current wording

The $1.3 million decrease in contracts and grants revenue for the nine months ended September 30, 2026, as compared to the nine months ended September 30, 2025, was primarily due to a decrease in revenue from our contract manufacturing and research and development agreements with Rockefeller University.

Previous wording

Personnel expenses primarily include salary, benefits, stock-based compensation and payroll taxes. The $3.7 million increase in personnel expenses for the six months ended June 30, 2026, as compared to the six months ended June 30, 2025, was primarily due to an increase in employee headcount.

Current wording

Personnel expenses primarily include salary, benefits, stock-based compensation and payroll taxes. The $7.5 million increase in personnel expenses for the nine months ended September 30, 2026, as compared to the nine months ended September 30, 2025, was primarily due to an increase in employee headcount.

Previous wording

Laboratory supplies expenses include laboratory materials and supplies, services, and other related expenses incurred in the development of our technology. The $0.3 million increase in laboratory supply expenses for the six months ended June 30, 2026, as compared to the six months ended June 30, 2025, was primarily due to higher laboratory materials and supplies purchases.

Current wording

Laboratory supplies expenses include laboratory materials and supplies, services, and other related expenses incurred in the development of our technology. The $1.4 million increase in laboratory supply expenses for the nine months ended September 30, 2026, as compared to the nine months ended September 30, 2025, was primarily due to higher laboratory materials and supplies purchases.

Previous wording

Facility expenses include depreciation, amortization, utilities, rent, maintenance and other related expenses incurred at our facilities. The $0.7 million decrease in facility expenses for the six months ended June 30, 2026, as compared to the six months ended June 30, 2025, was primarily due to lower expense related to our leased facilities.

Current wording

Facility expenses include depreciation, amortization, utilities, rent, maintenance and other related expenses incurred at our facilities. The $0.7 million decrease in facility expenses for the nine months ended September 30, 2026, as compared to the nine months ended September 30, 2025, was primarily due to lower expense related to our leased facilities.

Previous wording

Product development expenses include clinical investigator site fees, external trial monitoring costs, data accumulation costs, contracted research and outside clinical drug product manufacturing. The $26.2 million increase in product development expenses for the six months ended June 30, 2026, as compared to the six months ended June 30, 2025, was primarily due to an increase in barzolvolimab clinical trial and contract manufacturing expenses.

Current wording

Product development expenses include clinical investigator site fees, external trial monitoring costs, data accumulation costs, contracted research and outside clinical drug product manufacturing. The $22.2 million increase in product development expenses for the nine months ended September 30, 2026, as compared to the nine months ended September 30, 2025, was primarily due to an increase in barzolvolimab clinical trial and contract manufacturing expenses.

Previous wording

The $3.3 million increase in general and administrative expenses for the six months ended June 30, 2026, as compared to the six months ended June 30, 2025, was primarily due to higher commercial planning expenses.

Current wording

The $7.5 million increase in general and administrative expenses for the nine months ended September 30, 2026, as compared to the nine months ended September 30, 2025, was primarily due to higher commercial planning expenses and an increase in employee headcount.

Previous wording

The $3.3 million decrease in investment and other income, net for the six months ended June 30, 2026, as compared to the six months ended June 30, 2025, was primarily due to lower cash and investment balances prior to the April 2026 underwritten public offering and lower yields on fixed income investments.

Current wording

The $3.2 million decrease in investment and other income, net for the nine months ended September 30, 2026, as compared to the nine months ended September 30, 2025, was primarily due to lower cash and investment balances prior to the April 2026 underwritten public offering and lower yields on fixed income investments.

Previous wording

The use of our cash flows for operations has primarily consisted of salaries and wages for our employees; facility and facility-related costs for our offices, laboratories and manufacturing facility; fees paid in connection with preclinical studies, clinical studies, contract manufacturing, laboratory supplies and services; and consulting, legal and other professional fees. We anticipate that our cash flows from operations will continue to be focused in these areas as we progress our current drug candidates through the clinical trial process and develop additional drug candidates. To date, the primary sources of cash flows from operations have been payments received from our collaborative partners and from government entities and payments received for contract manufacturing and research and development services provided by us. The timing of any new contract manufacturing and research and development agreements, collaboration agreements, government contracts or grants and any payments under these agreements, contracts or grants cannot be easily predicted and may vary significantly from quarter to quarter.

Current wording

The use of our cash flows for operations has primarily consisted of salaries and wages for our employees; facility and facility-related costs for our offices, laboratories and manufacturing facility; fees paid in connection with preclinical studies, clinical studies, contract manufacturing, laboratory supplies and services; activities to support and prepare for potential commercialization; and consulting, legal and other professional fees. We anticipate that our cash flows from operations will continue to be focused in these areas as we progress our current drug candidates through the clinical trial process and develop additional drug candidates. To date, the primary sources of cash flows from operations have been payments received from our collaborative partners and from government entities and payments received for contract manufacturing and research and development services provided by us. The timing of any new contract manufacturing and research and development agreements, collaboration agreements, government contracts or grants and any payments under these agreements, contracts or grants cannot be easily predicted and may vary significantly from quarter to quarter.

Previous wording

At June 30, 2026, our principal sources of liquidity consisted of cash, cash equivalents and marketable securities of $717.6 million. We have had recurring losses and incurred a loss of $152.2 million for the six months ended June 30, 2026. Net cash used in operations for the six months ended June 30, 2026 was $123.0 million. We believe that the cash, cash equivalents and marketable securities at June 30, 2026 are sufficient to meet estimated working capital requirements and fund current planned operations through 2028. This could be impacted if we elect to pay the future milestone under the Settlement Agreement with SRS in cash, in the event that we achieve the milestone related to that payment.

Current wording

At September 30, 2026, our principal sources of liquidity consisted of cash, cash equivalents and marketable securities of $650.3 million. We have had recurring losses and incurred a loss of $227.7 million for the nine months ended September 30, 2026. Net cash used in operations for the nine months ended September 30, 2026 was $188.0 million. We believe that the cash, cash equivalents and marketable securities at September 30, 2026 are sufficient to meet estimated working capital requirements and fund current planned operations through 2028. This could be impacted if we elect to pay the future milestone under the Settlement Agreement with SRS in cash, in the event that we achieve the milestone related to that payment.

Previous wording

During the next twelve months, we may take further steps to raise additional capital to meet our long-term liquidity needs including, but not limited to, one or more of the following: the licensing of drug candidates with existing or new collaborative partners, possible business combinations, issuance of debt, or the issuance of common stock or other securities via private placements or public offerings. Although we have been successful in raising capital in the past, there can be no assurance that additional financing will be available on acceptable terms, if at all, and our negotiating position in capital raising efforts may worsen as existing resources are used. There is also no assurance that we will be able to enter into further collaborative relationships. Additional equity financings may be dilutive to our stockholders; debt financings, if available, may involve significant cash payment obligations and covenants that restrict our ability to operate as a business; and licensing or strategic collaborations may result in royalties or other terms which reduce our economic potential from products under development. Our ability to continue funding our planned operations into and beyond twelve months from the issuance date is also dependent on the timing and manner of payment of the future milestone under the Settlement Agreement with SRS, in the event that we achieve the milestone related to that payment. We may decide to pay that milestone payment in cash, shares of our common stock or a combination thereof. If we are unable to raise the funds necessary to meet our long-term liquidity needs, we may have to delay or discontinue the development of one or more programs, discontinue or delay ongoing or anticipated clinical trials, license out programs earlier than expected, raise funds at a significant discount or on other unfavorable terms, if at all, or sell all or a part of our business.

Current wording

During the next twelve months, we may take further steps to raise additional capital to meet our long-term liquidity needs including, but not limited to, one or more of the following: the licensing of drug candidates with existing or new collaborative partners, possible business combinations, issuance of debt, or the issuance of common stock or other securities via private placements or public offerings. Although we have been successful in raising capital in the past, there can be no assurance that additional financing will be available on acceptable terms, if at all, and our negotiating position in capital raising efforts may worsen as existing resources are used. There is also no assurance that we will be able to enter into further collaborative relationships. Additional equity financings may be dilutive to our stockholders; debt financings, if available, may involve significant cash payment obligations and covenants that restrict our ability to operate as a business; and licensing or strategic collaborations may result in royalties or other terms which reduce our economic potential from products under development. Our ability to continue funding our planned operations into and beyond twelve months from the issuance date is also dependent on the timing and manner of payment of the future milestone under the Settlement Agreement with SRS, in the event that we achieve the milestone related to that payment. We may decide to pay that milestone payment in cash, shares of our common stock or a combination thereof. If we are unable to raise the funds necessary to meet our long-term liquidity needs, we may have to delay or discontinue the development of one or more programs, discontinue or delay ongoing or anticipated clinical trials, license out programs earlier than expected, delay commercialization activities, raise funds at a significant discount or on other unfavorable terms, if at all, or sell all or a part of our business.

Previous wording

Net cash used in operating activities was $123.0 million for the six months ended June 30, 2026 as compared to $98.4 million for the six months ended June 30, 2025. The increase in net cash used in operating activities was primarily due to an increase in research and development expenses related to barzolvolimab, partially offset by an increase in accounts payable during the six months ended June 30, 2026. We expect that cash used in operating activities will increase over the next twelve months as a result of the expanded development of barzolvolimab.

Current wording

Net cash used in operating activities was $188.0 million for the nine months ended September 30, 2026 as compared to $147.0 million for the nine months ended September 30, 2025. The increase in net cash used in operating activities was primarily due to an increase in research and development expenses related to barzolvolimab and an increase in general and administrative expenses, partially offset by an increase in accounts payable during the nine months ended September 30, 2026. We expect that cash used in operating activities will increase over the next twelve months as a result of the increased costs associated with the development of barzolvolimab.

Previous wording

We have incurred and will continue to incur significant costs in the area of research and development, including preclinical and clinical trials and clinical drug product manufacturing as our drug candidates are developed. We plan to spend significant amounts to progress our current drug candidates through the clinical trial process as well as to develop additional drug candidates. As our drug candidates progress through the clinical trial process, we may be obligated to make significant milestone payments, pursuant to our existing arrangements and arrangements we may enter in the future.

Current wording

We have incurred and will continue to incur significant costs in the area of research and development, including preclinical and clinical trials and clinical drug product manufacturing as our drug candidates are developed. We plan to spend significant amounts to progress our current drug candidates through the clinical trial process as well as to develop additional drug candidates. As our drug

Previous wording

Net cash used in investing activities was $183.4 million for the six months ended June 30, 2026 compared to net cash provided by investing activities of $92.8 million for the six months ended June 30, 2025. The increase in net cash used in investing activities was primarily due to net purchases of marketable securities of $178.6 million for the six months ended June 30, 2026 as compared to net sales and maturities of marketable securities of $93.8 million for the six months ended June 30, 2025.

Current wording

Net cash used in investing activities was $140.0 million for the nine months ended September 30, 2026 compared to net cash provided by investing activities of $153.6 million for the nine months ended September 30, 2025. The increase in net cash used in investing activities was primarily due to net purchases of marketable securities of $133.5 million for the nine months ended September 30, 2026 as compared to net sales and maturities of marketable securities of $155.1 million for the nine months ended September 30, 2025.

Previous wording

Net cash provided by financing activities was $325.0 million for the six months ended June 30, 2026 as compared to $0.3 million for the six months ended June 30, 2025. The increase in net cash provided by financing activities was primarily due to an increase in proceeds from stock issuances.

Current wording

Net cash provided by financing activities was $326.1 million for the nine months ended September 30, 2026 as compared to $1.0 million for the nine months ended September 30, 2025. The increase in net cash provided by financing activities was primarily due to an increase in proceeds from stock issuances.