ANAPTYSBIO, INC

Previous wording

You should read the following discussion and analysis of our financial condition and results of operations together with our unaudited consolidated financial statements and related notes for the six months ended June 30, 2025, included in Part I, Item 1 of this report and with our audited consolidated financial statements and related notes thereto for the year ended December 31, 2024 included in our Annual Report on Form 10-K. This discussion and other sections of this Quarterly Report contain forward-looking statements that involve risks and uncertainties, such as our plans, objectives, expectations, intentions, and beliefs. Our actual results could differ materially from those discussed in these forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to, those identified below and those discussed in the section entitled “Risk Factors” included in Part II, Item 1A of this Quarterly Report. You should also carefully read “Special Note Regarding Forward-Looking Statements.”

Current wording

You should read the following discussion and analysis of our financial condition and results of operations together with our unaudited consolidated financial statements and related notes for the nine months ended September 30, 2025, included in Part I, Item 1 of this Quarterly Report and with our audited consolidated financial statements and related notes thereto for the year ended December 31, 2024 included in our Annual Report on Form 10-K. This discussion and other sections of this Quarterly Report contain forward-looking statements that involve risks and uncertainties, such as our plans, objectives, expectations, intentions, and beliefs. Our actual results could differ materially from those discussed in these forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to, those identified below and those discussed in the section entitled “Risk Factors” included in Part II, Item 1A of this Quarterly Report. You should also carefully read “Special Note Regarding Forward-Looking Statements.”

Previous wording

We are a clinical-stage biotechnology company focused on delivering innovative immunology therapeutics for autoimmune and inflammatory diseases. Our pipeline includes our lead program, rosnilimab, a selective and potent pathogenic T cell depleter, that completed a Phase 2b trial for the treatment of moderate-to-severe rheumatoid arthritis (“RA”) and is in a Phase 2 trial for the treatment of moderate-to-severe ulcerative colitis (“UC”). We also have other antibodies in our portfolio, including ANB033, a CD122 antagonist, in celiac disease (“CeD”), and ANB101, a BDCA2 modulator, both in Phase 1 trials. We have also discovered and out-licensed in financial collaborations multiple therapeutic antibodies, including a PD-1 antagonist (Jemperli (dostarlimab-gxly) or “Jemperli”) to GSK and an IL-36R antagonist (imsidolimab) to Vanda Pharmaceuticals Inc. (“Vanda”). We currently recognize revenue from milestones and royalties achieved under our immuno-oncology collaboration with GSK and license and transition services revenue from our collaboration with Vanda .

Current wording

We are a clinical-stage biotechnology company focused on delivering innovative immunology therapeutics for autoimmune and inflammatory diseases. Our pipeline includes our lead program, rosnilimab, a selective and potent pathogenic T cell depleter, that completed a Phase 2b trial for the treatment of moderate-to-severe rheumatoid arthritis (“RA”) and is in a Phase 2 trial for the treatment of moderate-to-severe ulcerative colitis (“UC”). Our pipeline also includes ANB033, a CD122 antagonist, in a Phase 1b trial for celiac disease (“CeD”) and ANB101, a BDCA2 modulator, in a Phase 1a trial. Anaptys has also discovered and out-licensed in financial collaborations multiple therapeutic antibodies, including a PD-1 antagonist (Jemperli (dostarlimab-gxly) or “Jemperli”) to GSK and an IL-36R antagonist (imsidolimab) to Vanda Pharmaceuticals Inc. (“Vanda”). We currently recognize revenue from milestones and royalties achieved under our immuno-oncology collaboration with GSK and license and transition services revenue from our collaboration with Vanda.

Previous wording

Rosnilimab is an IgG1 antibody that directly targets pathogenic T cells, such as activated Tph/Tfh and T effector cells, in the periphery or inflamed tissue. These T cells, when activated, proliferate and migrate, and secrete the inflammatory cytokines that are the drivers of autoimmune and inflammatory diseases. Rosnilimab is designed to selectively and potently deplete pathogenic T cells in both inflamed tissue and the periphery while sparing non-pathogenic T cells, including naïve T cells, to preserve overall immune function and restore immune homeostasis. This drives specific immunological outcomes, such as a reduction in T cell proliferation, migration and cytokine secretion, and a reduction of plasma cell generation and autoantibody levels. We announced positive top-line data from a healthy volunteer Phase 1 trial of rosnilimab in November 2021. A total of 144 subjects were enrolled in the randomized, double-blind, placebo-controlled healthy volunteer Phase 1 trial, where single ascending dose (“SAD”) cohorts received subcutaneous or intravenous (“IV”) single doses of rosnilimab up to 600mg or placebo, while multiple ascending dose (“MAD”) cohorts received four weekly subcutaneous doses of rosnilimab ranging up to 400mg or placebo. Rosnilimab was generally well-tolerated and no dose limiting toxicities were observed. Rosnilimab demonstrated a favorable pharmacokinetic (“PK”) profile with an estimated two-week half-life for subcutaneous and IV routes of administration.

Current wording

Rosnilimab is an IgG1 antibody that directly targets pathogenic T cells, such as activated Tph/Tfh and T effector cells, in the periphery or inflamed tissue. These T cells, when activated, proliferate and migrate, and secrete the inflammatory cytokines that are the drivers of autoimmune and inflammatory diseases. Rosnilimab is designed to selectively and potently deplete pathogenic T cells in both inflamed tissue and the periphery while sparing non-pathogenic T cells, including naïve T cells, to preserve overall immune function and restore immune homeostasis. This drives specific immunological outcomes, such as a reduction in T cell proliferation, migration and cytokine secretion, and a reduction of plasma cell generation and autoantibody levels. We announced positive top-line data from a healthy volunteer Phase 1 trial of rosnilimab in November 2021. A total of 144 subjects were enrolled in the randomized, double-blind, placebo-controlled healthy volunteer Phase 1 trial, where single ascending dose (“SAD”) cohorts received subcutaneous (“SC”) or intravenous (“IV”) single doses of rosnilimab up to 600mg or placebo, while multiple ascending dose (“MAD”) cohorts received four weekly subcutaneous doses of rosnilimab ranging up to 400mg or placebo. Rosnilimab was generally well-tolerated and no dose limiting toxicities were observed. Rosnilimab demonstrated a favorable pharmacokinetic (“PK”) profile with an estimated two-week half-life for subcutaneous and IV routes of administration.

Previous wording

Following completion of the Week 14 visit, 69% (or 220 of the 318) rosnilimab-treated patients who achieved CDAI LDA at this timepoint continued their assigned treatment through six months in a blinded, all-active treatment period. At six months, rosnilimab demonstrated clinically meaningful efficacy with deepening of responses through six months on CDAI LDA, CDAI remission and ACR70. Importantly, this was particularly observed in b/tsDMARD-experienced patients for the 400mg Q4W and 600mg Q2W doses, showing a dose response relative to the 100mg Q4W dose. Furthermore, we believe off-drug durability for at least 3 months after treatment suggest potential for extended dosing (e.g., Q8W/Q12W) after initial monthly dosing. Due to the trial design, max response rates for rosnilimab have not yet been observed as strict criteria at Week 14 prevented additional patients with meaningful improvement from continuing treatment in the trial.

Current wording

Following completion of the Week 14 visit, 69% (or 220 of the 318) rosnilimab-treated patients who achieved CDAI LDA at this timepoint continued their assigned treatment through six months in a blinded, all-active treatment period. At six months, rosnilimab demonstrated clinically meaningful efficacy with deepening of responses through six months on CDAI LDA, CDAI remission and ACR70 and independent of prior treatments, including anti-TNFα, anti-IL6R or JAK inhibitors. Importantly, this was particularly observed in b/tsDMARD-experienced patients for the 400mg Q4W and 600mg Q2W doses, showing a dose response relative to the 100mg Q4W dose. Furthermore, Week 28 responses across multiple clinically meaningful measures, including CDAI LDA, mean CDAI, mean DAS28-CRP and ACR50/70, were durable off drug through at least three months after the last rosnilimab dose and we believe suggests potential for extended dosing (e.g., Q8W/Q12W) after initial monthly dosing. Due to the trial design, max response rates for rosnilimab have not yet been observed as strict criteria at Week 14 prevented additional patients with meaningful improvement from continuing treatment in the trial.

Previous wording

Consistent with prior studies, a favorable safety and tolerability profile across all rosnilimab doses was observed with no treatment-related serious adverse events (“SAEs”), malignancies, anaphylaxis or systemic hypersensitivity, and a low incidence of injection site reactions. Most adverse events (“AEs”) were mild to moderate in severity. Less than 2% of patients in the entire trial discontinued rosnilimab due to an AE, including only one patient after three months for a moderate headache treated with over-the-counter pain medication. Non-treatment related SAEs observed were consistent with known RA patient history and comorbidities.

Current wording

Consistent with prior studies, a favorable safety and tolerability profile across all rosnilimab doses through end-of-trial follow up at Week 38 was observed with no treatment-related serious adverse events (“SAEs”), malignancies, anaphylaxis or systemic hypersensitivity, and a low incidence of injection site reactions. Most adverse events (“AEs”) were mild to moderate in severity. Less than 2% of patients in the entire trial discontinued rosnilimab due to an AE, including only one patient after three months for a moderate headache treated with over-the-counter pain medication. Non-treatment related SAEs observed were consistent with known RA patient history and comorbidities.

Previous wording

We are also conducting a randomized placebo-controlled 132-patient, global Phase 2 trial assessing two dose levels of subcutaneously administered rosnilimab in moderate-to-severe UC. Rosnilimab will be dosed for up to 48 weeks on well-established endpoints including clinical remission on the modified Mayo score (“mMS”), clinical response on the mMS and endoscopic remission. The primary statistical analysis is at Week 12 on well-established endpoints, including the primary endpoint of change from baseline in modified Mayo score (mMS) and supportive secondary endpoints of clinical response on mMS, clinical remission on mMS and endoscopic remission. All patients in all three study arms treat-through to Week 24 and remain blinded to the treatment arm. Placebo-treated patients who achieved clinical response on partial modified Mayo score (“pmMS”) at Week 12 remain on placebo, while placebo-treated patients who are non-responders are crossed over to the high-dose rosnilimab treatment arm. Patients who are in clinical response on pmMS at Week 24 are eligible for an additional 26-week blinded treatment extension period (“TEP”) (50 weeks of total treatment).

Current wording

We are also conducting a randomized placebo-controlled 132-patient, global Phase 2 trial assessing two dose levels of subcutaneously administered rosnilimab in moderate-to-severe UC. Rosnilimab will be dosed for up to 48 weeks on well-established endpoints including clinical remission on the modified Mayo score (“mMS”), clinical response on the mMS and endoscopic remission. The primary statistical analysis is at Week 12 on well-established endpoints, including the primary endpoint of change from baseline in modified Mayo score (mMS) and supportive secondary endpoints of clinical response on mMS and clinical remission on mMS. All patients in all three study arms treat-through to Week 24 and remain blinded to the treatment arm. Placebo-treated patients who achieved clinical response on partial modified Mayo score (“pmMS”) at Week 12 remain on placebo, while placebo-treated patients who are non-responders are crossed over to the high-dose rosnilimab treatment arm. Patients who are in clinical response on pmMS at Week 24 are eligible for an additional 26-week blinded treatment extension period (“TEP”) (50 weeks of total treatment).

Previous wording

We anticipate reporting top-line Phase 2 data through Week 12 in the UC trial in the fourth quarter of 2025.

Current wording

We anticipate reporting top-line Phase 2 data through Week 12 in the UC trial in November or December 2025.

Previous wording

ANB033 targets CD122, the common beta subunit shared by the IL-15 and IL-2 receptors. IL-15 and IL-2 signaling mediate the proliferation and survival of NK cells and certain CD8 T cell subsets. ANB033 is an antibody designed with an affinity to CD122 that inhibits IL-15 and IL-2 signaling through the low affinity IL-2 receptor (comprised of CD122 and the common gamma subunit, CD132) and the high affinity IL-2 receptor (comprised of CD122, CD132 and the alpha receptor subunit for IL-2, CD25) expressed by activated CD4 effector T cells. This leads to the potential to achieve and maintain remission of inflammation through the reduction of disease-causing NK cells, certain CD8 T cell subsets and reducing inflammatory cytokine secretion by activated CD4+ T cells. By preventing the consumption of IL-2 by pathogenic cells that express the low affinity IL-2 receptor, circulating levels of IL-2 may increase, potentially enhancing regulatory T cell numbers that express the high affinity IL-2 receptor in the setting of inflammation.

Current wording

ANB033 targets CD122, the common beta subunit shared by the IL-15 and IL-2 receptors. IL-15 and IL-2 signaling mediate the proliferation and survival of NK cells and certain CD8 T cell subsets. ANB033 is an antibody designed with an affinity to CD122 that inhibits IL-15 and IL-2 signaling through the intermediate affinity IL-2 receptor (comprised of CD122 and the common gamma subunit, CD132) and the high affinity IL-2 receptor (comprised of CD122, CD132 and the alpha receptor subunit for IL-2, CD25) expressed by activated CD4 effector T cells. This leads to the potential to achieve and maintain remission of inflammation through the reduction of disease-causing NK cells, certain CD8 T cell subsets and reducing inflammatory cytokine secretion by activated CD4+ T cells and ILC2 cells. By preventing the consumption of IL-2 by pathogenic cells, circulating levels of IL-2 may increase, potentially enhancing regulatory T cell numbers that express the high affinity IL-2 receptor in the setting of inflammation.

Previous wording

We initiated a Phase 1 clinical trial of ANB101 in healthy volunteers in March 2025.

Current wording

We initiated a Phase 1 clinical trial of ANB101 in healthy volunteers in March 2025 and the trial is ongoing.

Previous wording

Under the GSK Agreement, a Biologics License Application (“BLA”) for our most advanced partnered program, which is a PD-1 antagonist antibody called Jemperli (dostarlimab), was approved by the FDA in April 2021 for the treatment of advanced or recurrent deficient mismatch repair endometrial cancer (“dMMREC”). In February 2023, the FDA granted full approval for this indication (from an accelerated approval). In addition, in April 2021 the European Medicines Agency (“EMA”) granted conditional marketing authorization in the European Union (“EU”) for Jemperli for use in women with mismatch repair deficient (“dMMR”)/microsatellite instability-high (“MSI-H”) recurrent or advanced endometrial cancer who have progressed on or following prior treatment with a platinum containing regimen. A second FDA approval was received in August 2021 for Jemperli in pan-deficient mismatch repair tumors (PdMMRT). In July 2023, the FDA approved Jemperli in combination with chemotherapy for the treatment of adult patients with dMMR MSI-H primary advanced or recurrent endometrial cancer. In December 2023, the EMA approved, in the EU, Jemperli plus chemotherapy for dMMR/MSI-H primary advanced or recurrent endometrial cancer. In August 2024, the FDA approved Jemperli plus chemotherapy for all adult patients with primary advanced or recurrent endometrial cancer. In January 2025, the EMA approved Jemperli plus chemotherapy for this same indication.

Current wording

Under the GSK Agreement, a Biologics License Application (“BLA”) for our most advanced partnered program, which is a PD-1 antagonist antibody called Jemperli (dostarlimab), was approved by the FDA in April 2021 for the treatment of advanced or recurrent deficient mismatch repair endometrial cancer (“dMMREC”). In February 2023, the FDA granted full approval for this indication (from an accelerated approval). In addition, in April 2021, the European Medicines Agency (“EMA”) granted conditional marketing authorization in the European Union (“EU”) for Jemperli for use in women with mismatch repair deficient (“dMMR”)/microsatellite instability-high (“MSI-H”) recurrent or advanced endometrial cancer who have progressed on or following prior treatment with a platinum containing regimen. A second FDA approval was received in August 2021 for Jemperli in pan-deficient mismatch repair tumors (PdMMRT). In July 2023, the FDA approved Jemperli in combination with chemotherapy for the treatment of adult patients with dMMR MSI-H primary advanced or recurrent endometrial cancer. In December 2023, the EMA approved, in the EU, Jemperli plus chemotherapy for dMMR/MSI-H primary advanced or recurrent endometrial cancer. In August 2024, the FDA approved Jemperli plus chemotherapy for all adult patients with primary advanced or recurrent endometrial cancer. In January 2025, the EMA approved Jemperli plus chemotherapy for this same indication. In October 2025, GSK terminated the TIM-3 antagonist antibody development program under our existing collaboration, and all rights to the TIM-3 antagonist antibody will be reverted to us in the near future.

Previous wording

Pursuant to the terms of the Vanda License Agreement, we received an upfront payment of $10.0 million and a $5.0 million payment for existing drug supply. We are also eligible to receive up to $35.0 million for future regulatory approval and sales milestones in addition to a 10% royalty on net sales.

Current wording

Pursuant to the terms of the Vanda License Agreement, we received an upfront payment of $10.0 million and a $5.0 million payment for existing drug supply. We are also eligible to receive a 10% royalty on net sales, as well as the following milestones under the Vanda License Agreement:

Previous wording

Our revenue has been derived from amortization of upfront license payments, research and development funding, milestone and royalty payments under collaboration and license agreements with our collaborators. From inception through June 30, 2025, we have recognized $396.6 million in revenue from our collaborators. We have not generated any revenue from product sales.

Current wording

Our revenue has been derived from amortization of upfront license payments, research and development funding, milestone and royalty payments under collaboration and license agreements with our collaborators. From inception through September 30, 2025, we have recognized $472.9 million in revenue from our collaborators. We have not generated any revenue from product sales.

Previous wording

Our management’s discussion and analysis of our financial condition and results of operations are based on our financial statements, which have been prepared in accordance with U.S. generally accepted accounting principles (“U.S. GAAP”). The preparation of these financial statements requires us to make judgments and estimates that affect the reported amounts of assets, liabilities, revenues, and expenses and the disclosure of contingent assets and liabilities in our financial statements. We base our estimates on historical experience, known trends and events, and various other factors that are believed to be reasonable under the circumstances. Actual results may differ from these estimates under different assumptions or conditions. On an ongoing basis, we evaluate our judgments and estimates in light of changes in circumstances, facts, and experience. We believe there have been no significant changes in our critical accounting policies as discussed in our Annual Report on Form 10-K filed with the Securities and Exchange Commission (the “SEC”) on February 27, 2025.

Current wording

Our management’s discussion and analysis of our financial condition and results of operations are based on our financial statements, which have been prepared in accordance with U.S. generally accepted accounting principles (“U.S. GAAP”). The preparation of these financial statements requires us to make judgments and estimates that affect the reported amounts of assets, liabilities, revenues, and expenses and the disclosure of contingent assets and liabilities in our financial statements. We base our estimates on historical experience, known trends and events, and various other factors that are believed to be reasonable under the circumstances. Actual results may differ from these estimates under different assumptions or conditions. On an ongoing basis, we evaluate our judgments and estimates in light of changes in circumstances, facts, and experience. We believe there have been no significant changes in our critical accounting policies as discussed in our Annual Report on Form 10-K filed with the SEC on February 27, 2025.

Previous wording

Results of Operations – Comparison of the Three and Six Months Ended June 30, 2025 and 2024

Current wording

Results of Operations – Comparison of the Three and Nine Months Ended September 30, 2025 and 2024

Previous wording

Collaboration revenue consists of milestone payments, royalty payments, upfront license fees and transition services provided under our collaboration agreements. We recognized no milestone revenue during each of the three and six months ended June 30, 2025 and 2024. We expect that any collaboration revenue we generate will continue to fluctuate from period to period as a result of the timing and amount of milestones from our existing collaborations.

Current wording

Collaboration revenue consists of milestone payments, royalty payments, upfront license fees and transition services provided under our collaboration agreements. We recognized a $50.0 million milestone during the three and nine months ended September 30, 2025 when Jemperli annual sales exceeded $750 million. Our first sales milestone for $15.0 million was recognized during the three and nine months ended September 30, 2024 when Jemperli annual sales exceeded $250 million. These milestone revenues are Jemperli non-cash revenue related to the Jemperli Royalty Monetization Agreement. We expect that any collaboration revenue we generate will continue to fluctuate from period to period as a result of the timing and amount of milestones from our existing collaborations.

Previous wording

Royalty revenue is a function of our partners’ product sales and the applicable royalty rate. During the three months ended June 30, 2025 and 2024, we recognized $22.2 million and $11.0 million, respectively, of royalty revenue related to the net sales of GSK’s Jemperli and Zejula. During the six months ended June 30, 2025 and 2024, we recognized $40.4 million and $18.2 million, respectively, of royalty revenue related to the net sales of GSK’s Jemperli and Zejula. All royalty revenue recognized for the three and six months ended June 30, 2025 and 2024 is non-cash revenue pursuant to the Royalty Monetization Agreements. For more information see Note 5 — Sale of Future Royalties in the accompanying notes to the consolidated financial statements.

Current wording

Royalty revenue is a function of our partners’ product sales and the applicable royalty rate. During the three months ended September 30, 2025 and 2024, we recognized $26.3 million and $15.0 million, respectively, of royalty revenue related to the net sales of GSK’s Jemperli and Zejula. During the nine months ended September 30, 2025 and 2024, we recognized $66.6 million and $33.2 million, respectively, of royalty revenue related to the net sales of GSK’s Jemperli and Zejula. All royalty revenue recognized for the three and nine months ended September 30, 2025 and 2024 is non-cash revenue pursuant to the Royalty Monetization Agreements. For more information see Note 5 — Sale of Future Royalties in the accompanying notes to the consolidated financial statements.

Previous wording

During the six months ended June 30, 2025, we recognized $9.6 million of license revenue under ASC 606 and recognized no license revenue under ASC 606 during the three months ended June 30, 2025. During the three and six months ended June 30, 2025, we recognized less than $0.1 million and $0.1 million for the three and six months ended June 30, 2025, related to transition services provided under our Vanda License Agreement. No revenue was recognized under this agreement during the three and six months ended June 30, 2024.

Current wording

During the nine months ended September 30, 2025, we recognized $9.6 million of license revenue under ASC 606 and recognized no license revenue under ASC 606 during the three months ended September 30, 2025. During the three and nine months ended September 30, 2025, we recognized $0.1 million and $0.2 million, respectively, related to transition services provided under our Vanda License Agreement. No revenue was recognized under this agreement during the three and nine months ended September 30, 2024.

Previous wording

Research and development expenses were $37.8 million during the three months ended June 30, 2025 compared to $42.0 million during the three months ended June 30, 2024 for a decrease of $4.2 million, primarily due to a $2.5 million decrease in clinical expenses, $3.4 million decrease in outside services for manufacturing expenses, offset by a $0.9 million increase in stock-based compensation expense, $0.3 million increase in salaries and related expenses, and $0.5 million increase in other research and development expenses.

Current wording

Research and development expenses were $31.4 million during the three months ended September 30, 2025 compared to $42.2 million during the three months ended September 30, 2024 for a decrease of $10.8 million, primarily due to a $8.3 million decrease in clinical expenses, $3.1 million decrease in outside services for manufacturing expenses, offset by a $0.5 million increase in stock-based compensation expense, and $0.1 million increase in salaries and related expenses.

Previous wording

Research and development expenses were $79.0 million during the six months ended June 30, 2025, consistent with the $79.0 million during the six months ended June 30, 2024. Expense category fluctuations were primarily due to a $4.1 million decrease in outside services for manufacturing expenses and a $0.2 million decrease in clinical expenses, offset by an increase of $1.7 million increase in salaries and related expenses, $1.9 million increase in stock-based compensation expense, and $0.7 million increase in other research and development expenses.

Current wording

Research and development expenses were $110.4 million during the nine months ended September 30, 2025, compared to $121.3 million during the nine months ended September 30, 2024, for a decrease of $10.9 million. Expense category fluctuations were primarily due to a $7.2 million decrease in outside services for manufacturing expenses and a $8.6 million decrease in clinical expenses, offset by an increase of $1.8 million increase in salaries and related expenses, $2.4 million increase in stock-based compensation expense, and $0.7 million increase in other research and development expenses.

Previous wording

General and administrative expenses were $10.6 million during the three months ended June 30, 2025 compared to $9.3 million during the three months ended June 30, 2024 for an increase of $1.3 million, primarily due to a $0.8 million increase in stock-based compensation, $0.6 million increase in personnel costs, and a $0.3 million increase in other general and administrative expenses, offset by $0.4 million decrease in market research.

Current wording

General and administrative expenses were $10.2 million during the three months ended September 30, 2025 compared to $10.6 million during the three months ended September 30, 2024 for a decrease of $0.4 million, primarily due to a $0.5 million decrease in market research, and $0.5 million decrease in personnel costs, offset by $0.5 million increase in stock-based compensation, and a $0.1 million increase in other general and administrative expenses.

Previous wording

General and administrative expenses were $24.7 million during the six months ended June 30, 2025 compared to $21.6 million during the six months ended June 30, 2024 for an increase of $3.1 million, primarily due to a $2.5 million increase in transaction costs related to our Vanda License Agreement, a $0.9 million increase in personnel costs, a $0.3 million increase in market research cost, and a $0.5 million increase in other general and administrative expenses, offset by a decrease of $1.1 million in stock-based compensation expense.

Current wording

General and administrative expenses were $34.9 million during the nine months ended September 30, 2025 compared to $32.2 million during the nine months ended September 30, 2024 for an increase of $2.7 million, primarily due to a $2.5 million increase in transaction costs related to our Vanda License Agreement, a $0.4 million increase in personnel costs, and a $0.6 million increase in other general and administrative expenses, offset by a decrease of $0.7 million in stock-based compensation expense, and a decrease of $0.1 million in market research.

Previous wording

Non-cash interest expense was $19.6 million and $11.0 million during the three months ended June 30, 2025 and 2024, respectively. The increase of $8.6 million in non-cash interest expense is primarily due to the Jemperli Amendment which increased the threshold amounts of aggregate Jemperli royalties and milestones to be received by Sagard.

Current wording

Non-cash interest expense was $22.5 million and $15.4 million during the three months ended September 30, 2025 and 2024, respectively. The increase of $7.1 million in non-cash interest expense is primarily due to the Jemperli Amendment which increased the threshold amounts of aggregate Jemperli royalties and milestones to be received by Sagard.

Previous wording

Non-cash interest expense was $37.7 million and $17.3 million during the six months ended June 30, 2025 and 2024, respectively. The increase of $20.4 million in non-cash interest expense is primarily due to the Jemperli Amendment which increased the threshold amounts of aggregate Jemperli royalties and milestones to be received by Sagard.

Current wording

Non-cash interest expense was $60.2 million and $32.7 million during the nine months ended September 30, 2025 and 2024, respectively. The increase of $27.5 million in non-cash interest expense is primarily due to the Jemperli Amendment which increased the threshold amounts of aggregate Jemperli royalties and milestones to be received by Sagard.

Previous wording

Interest income was $3.7 million and $4.6 million during the three months ended June 30, 2025 and 2024, respectively, which primarily related to our short-term and long-term investments. The decrease in interest income is primarily due to the decrease in investment balances as well as timing of sales, maturities and purchases of our investments.

Current wording

Interest income was $2.9 million and $5.3 million during the three months ended September 30, 2025 and 2024, respectively, which primarily related to our short-term and long-term investments. The decrease in interest income is primarily due to the decrease in investment balances as well as timing of sales, maturities and purchases of our investments.

Previous wording

Interest income was $8.1 million and $9.2 million during the six months ended June 30, 2025 and 2024, respectively, which primarily related to our short-term and long-term investments. The decrease in interest income is primarily due to the decrease in investment balances as well as timing of sales, maturities and purchases of our investments.

Current wording

Interest income was $11.0 million and $14.5 million during the nine months ended September 30, 2025 and 2024, respectively, which primarily related to our short-term and long-term investments. The decrease in interest income is primarily due to the decrease in investment balances as well as timing of sales, maturities and purchases of our investments.

Previous wording

Other income (expense), net was $5.4 million of income and less than $0.1 million of expense for the six months ended June 30, 2025 and 2024, respectively. The increase was primarily related to $5.4 million of other income recognized from existing drug supply transferred to Vanda in accordance with our Vanda License Agreement.

Current wording

Other income (expense), net was $5.4 million of income and less than $0.1 million of expense for the nine months ended September 30, 2025 and 2024, respectively. The increase was primarily related to $5.4 million of other income recognized from existing drug supply transferred to Vanda in accordance with our Vanda License Agreement.

Previous wording

From our inception through June 30, 2025, we have received an aggregate of $1.3 billion to fund our operations, which included $739.9 million from the sale of equity securities, $335.0 million from the sale of future royalties, and $249.2 million from our collaboration agreements. As of June 30, 2025, we had $293.7 million in cash, cash equivalents and investments.

Current wording

From our inception through September 30, 2025, we have received an aggregate of $1.3 billion to fund our operations, which included $740.2 million from the sale of equity securities, $335.0 million from the sale of future royalties, and $249.2 million from our collaboration agreements. As of September 30, 2025, we had $256.7 million in cash, cash equivalents and investments.

Previous wording

In addition to our existing cash, cash equivalents and investments, we are eligible to earn milestone and other contingent payments for the achievement of defined collaboration objectives and certain nonclinical, clinical, regulatory and sales-based events, and royalty payments under our collaboration agreements, including the GSK Agreement, the GSK Settlement Agreement, and the Vanda License Agreement. Our ability to earn these milestone and contingent payments and the timing of achieving these milestones is primarily dependent upon the outcome of our collaborators’ research and development activities. Our rights to payments under our collaboration agreements are our only committed external source of funds.

Current wording

In addition to our existing cash, cash equivalents and investments, we are eligible to earn milestone and other contingent payments for the achievement of defined collaboration objectives and certain regulatory and sales-based events, and royalty payments under our collaboration agreements, including the GSK Agreement, the GSK Settlement Agreement, and the Vanda License Agreement. Our ability to earn these milestone and contingent payments and the timing of achieving these milestones is primarily dependent upon the outcome of our collaborators’ research and development and sales-based activities. Our rights to payments under our collaboration agreements are our only committed external source of funds.

Previous wording

Cash, cash equivalents and investments totaled $293.7 million as of June 30, 2025, compared to $420.8 million as of December 31, 2024. We believe that our existing cash, cash equivalents and investments will fund our current operating plan for at least the next twelve months from the issuance of our consolidated financial statements. We have based this estimate on assumptions that may prove to be wrong, and we could use our capital resources sooner than we expect. Additionally, the process of testing product candidates in clinical trials and seeking regulatory approval is costly, and the timing of progress and expenses in these trials is uncertain.

Current wording

Cash, cash equivalents and investments totaled $256.7 million as of September 30, 2025, compared to $420.8 million as of December 31, 2024. We believe that our existing cash, cash equivalents and investments will fund our current operating plan for at least the next twelve months from the issuance of our consolidated financial statements. We have based this estimate on assumptions that may prove to be wrong, and we could use our capital resources sooner than we expect. Additionally, the process of testing product candidates in clinical trials and seeking regulatory approval is costly, and the timing of progress and expenses in these trials is uncertain.

Previous wording

The following table summarizes our cash flows for the six months ended June 30, 2025 and 2024:

Current wording

The following table summarizes our cash flows for the nine months ended September 30, 2025 and 2024:

Previous wording

Net cash used in operating activities during the six months ended June 30, 2025 of $50.9 million was primarily due to our net loss of $78.0 million, adjusted for addbacks for non-cash expenses of $54.0 million, which includes depreciation, stock-based compensation, amortization of operating ROU assets, non-cash interest expense, income from marketable securities and net decreases in working capital of $26.9 million.

Current wording

Net cash used in operating activities during the nine months ended September 30, 2025 of $78.3 million was primarily due to our net loss of $62.8 million, adjusted for addbacks for non-cash expenses of $85.1 million, which includes depreciation, stock-based compensation, amortization of operating ROU assets, non-cash interest expense, income from marketable securities and net decreases in working capital of $100.6 million, which includes decreases related to receivables from collaborative partners, accounts payable and other liabilities, and operating lease liabilities, partially offset by an increase related to prepaid expenses and other assets.

Previous wording

Net cash used in operating activities during the six months ended June 30, 2024 of $58.6 million was primarily due to our net loss of $90.6 million, adjusted for addbacks for non-cash expenses of $30.7 million, which includes depreciation, stock-based compensation, amortization of operating ROU assets, non-cash interest expense, income from marketable securities, and net increases in working capital of $1.3 million.

Current wording

Net cash used in operating activities during the nine months ended September 30, 2024 of $68.7 million was primarily due to our net loss of $123.4 million, adjusted for addbacks for non-cash expenses of $52.3 million, which includes depreciation, stock-based compensation, amortization of operating ROU assets, non-cash interest expense, income from marketable securities, and net increases in working capital of $2.4 million.

Previous wording

Net cash provided by investing activities during the six months ended June 30, 2025 and 2024 of $51.3 million and $66.2 million, respectively, primarily relates to the timing of sales, maturities and purchases of our investments.

Current wording

Net cash provided by investing activities during the nine months ended September 30, 2025 and 2024 of $154.5 million and $124.8 million, respectively, primarily relates to the timing of sales, maturities and purchases of our investments.

Previous wording

Net cash used in financing activities during the six months ended June 30, 2025 of $79.1 million was primarily due to $23.8 million for repayments of the liability to the sale of future royalties, $55.5 million used for the repurchase and retirement of common stock, and $1.5 million for net share settlement of equity awards, partially offset by $1.7 million of cash received for the issuance of common stock.

Current wording

Net cash used in financing activities during the nine months ended September 30, 2025 of $89.5 million was primarily due to $24.8 million for repayments of the liability for the sale of future royalties, $65.2 million used for the repurchase and retirement of common stock, and $1.5 million for net share settlement of equity awards, partially offset by $2.0 million of cash received for the issuance of common stock.

Previous wording

The net cash provided by financing activities during the six months ended June 30, 2024 of $28.3 million was primarily related to $50.0 million received for the sale of future royalties, $1.8 million of cash received for the issuance of common stock, offset by $16.0 million for repayments of the liability for the sale of future royalties and $7.5 million for net share settlement of equity awards.

Current wording

The net cash provided by financing activities during the nine months ended September 30, 2024 of $99.5 million was primarily related to $94.4 million of proceeds received from public offerings, net of underwriters’ fees, $50.0 million received for the sale of future royalties, $5.9 million of cash received for the issuance of common stock, offset by $42.8 million for repayments of the liability for the sale of future royalties, $7.5 million for net share settlement of equity awards, and $0.5 million payments for offering and debt issuance costs.