Vera Therapeutics, Inc.

Previous wording

We are a late clinical-stage biotechnology company focused on developing and commercializing transformative treatments for patients with serious immunological diseases. Our lead product candidate, atacicept, a fully humanized TACI-Fc fusion protein that binds both B-cell activating factor (BAFF) and A proliferation-inducing ligand (APRIL) and is self-administered subcutaneously, is currently being evaluated for the treatment of immunoglobulin A nephropathy (IgAN). In April 2025, we completed full enrollment of ORIGIN 3, the pivotal Phase 3 trial of atacicept 150 mg in IgAN. The primary efficacy endpoint evaluated 36-week urine protein creatinine ratio (UPCR) in the initial cohort of 200 participants. We announced primary endpoint results in the second quarter of 2025, supporting our planned submission for regulatory approval in the fourth quarter of 2025. The Phase 2b ORIGIN clinical trial evaluated the safety and efficacy of atacicept in 116 participants with IgAN and reported positive results at 24 weeks in January 2023, 36 weeks in June 2023, and 96 weeks in October 2024. The trial remained blinded through 36 weeks, after which all participants were eligible for the open label extension portion of the study and received atacicept 150 mg through 96 weeks. At 24 and 36 weeks, atacicept met its primary and key secondary endpoints, respectively, with statistically significant reductions in UPCR, and stable estimated glomerular filtration rate (eGFR) was observed with clinically meaningful and statistically significant difference for participants on atacicept versus placebo. Participants treated with atacicept demonstrated reductions in galactose-deficient IgA1 (Gd-IgA1), the autoantigen produced by B cells in patients with IgAN, and a reduction in hematuria. The improvements in Gd-IgA1, hematuria, UPCR and eGFR represent the quartet of findings consistent with IgAN disease modification. The 96-week open-label extension results showed consistent and sustained reductions in Gd-IgA1, hematuria, and UPCR, with continued eGFR stabilization at a rate similar to the general population without kidney disease. Additionally, atacicept’s safety profile was comparable to placebo. We have also committed to providing long-term access to atacicept for all ORIGIN participants by initiating ORIGIN EXTEND, a long-term Phase 2 extension study that offers open-label atacicept to participants who completed ORIGIN Phase 2b or 3 until commercial availability in their country or region. We believe that atacicept has pipeline in a molecule potential, with potential application in multiple diseases. Based on data from the Phase 2b ORIGIN trial, the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation to atacicept for the treatment of IgAN. In the Phase 2 PIONEER clinical trial, we are evaluating atacicept in non-IgAN autoimmune kidney diseases, including primary membranous nephropathy (pMN), focal segmental glomerulosclerosis (FSGS) and minimal …

Excerpt shortened here; the source contains the full paragraph.

Current wording

The Phase 2b ORIGIN clinical trial evaluated the safety and efficacy of atacicept in 116 participants with IgAN and reported positive results at 24 weeks in January 2023, 36 weeks in June 2023, and 96 weeks in October 2024. The trial remained blinded through 36 weeks, after which all participants were eligible for the open label extension portion of the study and received atacicept 150 mg through 96 weeks. At 24 and 36 weeks, atacicept met its primary and key secondary endpoints, respectively, with statistically significant reductions in UPCR, and stable estimated glomerular filtration rate (eGFR) was observed with clinically meaningful and statistically significant difference for participants on atacicept versus placebo. Participants treated with atacicept demonstrated reductions in galactose-deficient IgA1 (Gd-IgA1), the autoantigen produced by B cells in patients with IgAN, and a reduction in hematuria. The improvements in Gd-IgA1, hematuria, UPCR and eGFR represent the quartet of findings consistent with IgAN disease modification. The 96-week open-label extension results showed consistent and sustained reductions in Gd-IgA1, hematuria, and UPCR, with continued eGFR stabilization at a rate similar to the general population without kidney disease. Additionally, atacicept’s safety profile was comparable to placebo. We have committed to providing long-term access to atacicept for all ORIGIN participants in ORIGIN EXTEND, a long-term Phase 2 extension study that offers open-label atacicept to participants who completed ORIGIN Phase 2b or 3 until commercial availability in their country or region. We are also conducting a clinical study to evaluate monthly dosing of atacicept in participants with IgAN. We believe that atacicept has pipeline in a molecule potential, with potential application in multiple diseases. Based on data from the Phase 2b ORIGIN trial, the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation to atacicept for the treatment of IgAN. In the Phase 2 PIONEER clinical trial, we are evaluating atacicept in non-IgAN autoimmune kidney diseases, including primary membranous nephropathy (pMN), focal segmental glomerulosclerosis (FSGS) and minimal change disease (MCD) in patients with anti-PLA2R antibodies or other auto-antibodies. Potential other future indications include several rheumatologic diseases such as systemic lupus erythematosus and Sjogren’s disease, and hematologic diseases, including idiopathic thrombocytopenic purpura and autoimmune hemolytic anemia. We also hold worldwide, exclusive development and commercial rights to MAU868, a potentially first-in-class monoclonal antibody to treat reactivated BK virus (BKV) infections for which we completed a Phase 2 clinical trial in 2022, and in January 2025, we acquired worldwide, exclusive development and commercial rights to VT-109, a novel, next-generation dual BAFF/APRIL inhibitor that is in preclinical development. We believe that our current pipeli…

Excerpt shortened here; the source contains the full paragraph.

Previous wording

To date, we have funded our operations primarily through proceeds from the sale of shares of our common stock, redeemable convertible preferred stock, debt financing and convertible promissory notes. As of June 30, 2025, we had $556.8 million in cash, cash equivalents and marketable securities, compared to $640.9 million as of December 31, 2024.

Current wording

To date, we have funded our operations primarily through proceeds from the sale of shares of our common stock, redeemable convertible preferred stock, debt financing and convertible promissory notes. As of September 30, 2025, we had $497.4 million in cash, cash equivalents and marketable securities, compared to $640.9 million as of December 31, 2024.

Previous wording

We have incurred significant operating losses since the commencement of our operations. Our net losses were $76.5 million and $33.7 million for the three months ended June 30, 2025 and 2024, respectively, and we expect to incur significant and increasing losses for the foreseeable future as we continue to advance our product candidates toward commercialization. Our net losses may fluctuate significantly from period to period, depending on the timing of expenditures on our research and development activities. As of June 30, 2025, we had an accumulated deficit of $589.5 million, compared to $461.3 million as of December 31, 2024. Our primary use of cash is to fund operating expenses, which consist of research and development and general and administrative expenditures. Cash used to fund operating expenses depends on the timing of when we pay these expenses, as reflected in the changes in our working capital balances.

Current wording

We have incurred significant operating losses since the commencement of our operations. Our net losses were $80.3 million and $46.6 million for the three months ended September 30, 2025 and 2024, respectively, and we expect to incur significant and increasing losses for the foreseeable future as we continue to advance our product candidates toward commercialization. Our net losses may fluctuate significantly from period to period, depending on the timing of expenditures on our research and development activities. As of September 30, 2025, we had an accumulated deficit of $669.8 million, compared to $461.3 million as of December 31, 2024. Our primary use of cash is to fund operating expenses, which consist of research and development and general and administrative expenditures. Cash used to fund operating expenses depends on the timing of when we pay these expenses, as reflected in the changes in our working capital balances.

Previous wording

attract, hire and retain additional clinical, scientific, quality control, and manufacturing management and administrative personnel; and

Current wording

attract, hire and retain additional clinical, scientific, quality control, commercial, and manufacturing management and administrative personnel; and

Previous wording

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

Current wording

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

Previous wording

Research and development expenses increased by $28.9 million, or 99%, to $58.2 million in the three months ended June 30, 2025, from $29.3 million in the three months ended June 30, 2024, primarily due to an increase of $10.7 million in contract drug manufacturing costs for clinical and potential commercial use, an increase of $5.8 million in clinical trial expenses mainly due to the PIONEER and ORIGIN EXTEND trials, an increase of $3.4 million in consulting and professional services, including a $2.4 million increase in medical affairs and commercial planning expenses as we prepare for potential regulatory approval and commercialization of atacicept, an increase of $8.2 million for employee compensation and related benefit expenses, including a $2.5 million increase in stock-based compensation expense, due to growth in research and development headcount, and an increase of $0.7 million in facilities and other, including a $0.4 million increase in travel expenses supporting research and development activities, including travel associated with medical conferences.

Current wording

Research and development expenses increased by $16.2 million, or 40%, to $56.5 million in the three months ended September 30, 2025, from $40.3 million in the three months ended September 30, 2024, due to an increase of $3.0 million in clinical trial expenses mainly due to increased expenses for the PIONEER and ORIGIN EXTEND trials, an increase of $4.1 million in consulting and professional services, including a $1.3 million increase in medical affairs and commercial planning expenses as we prepare for potential regulatory approval and commercialization of atacicept, an increase of $8.7 million for employee compensation and related benefit expenses, including a $2.3 million increase in stock-based compensation expense, due to growth in research and development headcount, and an increase of $0.7 million in facilities and other, including a $0.4 million increase in travel expenses supporting research and development activities, due mostly to travel associated with medical conferences.

Previous wording

Research and development expenses increased by $47.0 million, or 89%, to $99.5 million in the six months ended June 30, 2025, from $52.5 million in the six months ended June 30, 2024, primarily due to an increase of $12.5 million in contract drug manufacturing costs for clinical and potential commercial use, an increase of $11.0 million in clinical trial expenses due to greater numbers of active sites and participants enrolled in ORIGIN 3 and expenses incurred for the PIONEER and ORIGIN EXTEND trials, an increase of $7.4 million in consulting and professional services, including a $5.3 million increase in medical affairs and commercial planning expenses as we prepare for potential regulatory approval and commercialization of atacicept, an increase of $14.6 million for employee compensation and related benefit expenses, including a $4.2 million increase in stock-based compensation expense, due to growth in research and development headcount, and an increase of $1.4 million in facilities and other, including a $0.9 million increase in travel expenses to support research and development activities, including travel associated with medical conferences.

Current wording

Research and development expenses increased by $63.1 million, or 68% to $155.9 million in the nine months ended September 30, 2025, from $92.8 million in the nine months ended September 30, 2024, due to an increase of $12.2 million in contract drug manufacturing costs for clinical and potential commercial use, an increase of $14.0 million in clinical trial expenses due to greater numbers of active sites and participants enrolled in ORIGIN 3 and expenses incurred for the PIONEER and ORIGIN EXTEND trials, an increase of $11.6 million in consulting and professional services, including a $6.6 million increase in medical affairs and commercial planning expenses as we prepare for potential regulatory approval and commercialization of atacicept, an increase of $23.3 million for employee compensation and related benefit expenses, including a $6.5 million increase in stock-based compensation expense, due to growth in research and development headcount, and an increase of $2.1 million in facilities and other, including a $1.3 million increase in travel expenses to support research and development activities, including travel associated with medical conferences.

Previous wording

We expect our research and development expenses to increase in future periods as we prepare applications for regulatory approval of atacicept in IgAN, conduct additional clinical trials of atacicept, and if we expand development of atacicept in other indications or product configurations, or other product candidates.

Current wording

We expect our research and development expenses to increase in future periods as we seek regulatory approval of atacicept in IgAN, conduct additional clinical trials of atacicept, and if we expand development of atacicept in other indications or product configurations, or other product candidates.

Previous wording

General and administrative expenses increased by $13.9 million, or 173%, to $21.9 million in the three months ended June 30, 2025, from $8.0 million in the three months ended June 30, 2024, primarily due to an increase of $6.5 million in employee compensation and related benefits expenses, including stock-based compensation, as a result of increased general and administrative employee headcount, an increase of $3.8 million in commercial planning and medical affairs expenses related to market research, market access and health economics activities, an increase of $0.8 million in legal expenses, an increase of $0.6 million in software expenses, an increase of $0.4 million in recruiting and placement fees and an increase of $0.4 million in business travel expenses.

Current wording

General and administrative expenses increased by $18.0 million, or 189%, to $27.5 million in the three months ended September 30, 2025, from $9.5 million in the three months ended September 30, 2024, primarily due to an increase of $8.4 million in employee compensation and related benefits expenses, including stock-based compensation, as a result of increased general and administrative employee headcount, an increase of $5.7 million in commercial planning and medical affairs expenses related to market research, market access and health economics activities related to commercialization planning of atacicept, an increase of $1.5 million in legal, accounting, and audit expenses, an increase of $0.6 million in software expenses, and an increase of $0.5 million in business travel expenses.

Previous wording

General and administrative expenses increased by $21.9 million, or 137%, to $37.9 million in the six months ended June 30, 2025, from $15.9 million in the six months ended June 30, 2024, primarily due to an increase of $10.9 million in employee compensation and related benefits expenses, including stock-based compensation, as a result of increased general and administrative employee headcount, an increase of $1.4 million in consulting expenses, including non-employee director stock-based compensation, an increase of $5.1 million in commercial and medical affairs expenses related to market research, market access and health economics activities, and an increase of $0.8 million in accounting and audit fees.

Current wording

General and administrative expenses increased by $39.9 million, or 157% to $65.3 million in the nine months ended September 30, 2025, from $25.4 million in the nine months ended September 30, 2024, due to an increase of $19.3 million in employee compensation and related benefits expenses, including stock-based compensation, as a result of increased general and administrative employee headcount, an increase of $10.8 million in commercial and medical affairs expenses related to market research, market access and health economics activities related to commercialization planning of atacicept, an increase of $2.8 million in legal, accounting, and audit fees, an increase of $1.7 million in consulting expenses, including non-employee director stock-based compensation, an increase of $1.2 million in software expenses, and an increase of $1.1 million in business travel expenses.

Previous wording

Other income, net, increased by $2.7 million, or 43%, to $9.1 million in the six months ended June 30, 2025, from $6.4 million in the six months ended June 30, 2024, primarily due to an increase of $3.9 million in interest income from greater balances of marketable securities held, partially offset by $0.9 million from debt issuance costs related to refinancing of credit facility in June 2025.

Current wording

Other income, net, increased by $3.2 million, or 34%, to $12.7 million in the nine months ended September 30, 2025, from $9.5 million in the nine months ended September 30, 2024, primarily due to an increase of $4.9 million in interest income from greater balances of marketable securities held, partially offset by $0.8 million from debt issuance costs related to refinancing of credit facility in June 2025 and $0.6 million in amortization of deferred debt issuance costs for unfunded loan commitments.

Previous wording

We anticipate that we will continue to incur net losses for the foreseeable future as we continue research and development activities of atacicept, MAU868, and VT-109, hire additional staff, including clinical, operational, administrative and management personnel, and incur additional expenses associated with operating as a public company. We expect to incur significant expenses and operating losses for the foreseeable future as we advance our clinical development activities and our product candidate portfolio. We expect that our research and development and general and administrative costs will increase substantially in connection with conducting additional clinical trials for our research programs and product candidates, contracting with third parties to support nonclinical studies and clinical trials, expanding our intellectual property portfolio, and providing general and administrative support for our operations. As a result, we will need additional capital to fund our operations, which we may obtain from additional equity or debt financings, collaborations, licensing arrangements, or other sources.

Current wording

We anticipate that we will continue to incur net losses for the foreseeable future as we continue research and development activities of atacicept, MAU868, and VT-109, hire additional staff, including clinical, operational, administrative and management personnel, and incur additional expenses associated with operating as a public company. We expect to incur significant expenses and operating losses for the foreseeable future as we advance our clinical development activities and our product candidate portfolio and eventually prepare for anticipated commercialization of atacicept. We expect that our research and development and general and administrative costs will increase substantially in connection with conducting additional clinical trials for our research programs and product candidates, contracting with third parties to support nonclinical studies and clinical trials, expanding our intellectual property portfolio, scaling up external commercial manufacturing capacity, establishing a sales, marketing and distribution infrastructure to commercialize any approved product candidates, and providing general and administrative support for our operations. As a result, we will need additional capital to fund our operations, which we may obtain from additional equity or debt financings, collaborations, licensing arrangements, or other sources.

Previous wording

As of June 30, 2025, we had cash, cash equivalents and marketable securities of $556.8 million, as compared to $640.9 million as of December 31, 2024. We believe, based on our current operating plan, that our cash, cash equivalents and marketable securities as of June 30, 2025 will be sufficient to fund our planned operations and capital expenditure requirements for at least the next 12 months from the date of this Quarterly Report on Form 10-Q.

Current wording

As of September 30, 2025, we had cash, cash equivalents and marketable securities of $497.4 million, as compared to $640.9 million as of December 31, 2024. We believe, based on our current operating plan, that our cash, cash equivalents and marketable securities as of September 30, 2025 will be sufficient to fund our planned operations and capital expenditure requirements for at least the next 12 months from the date of this Quarterly Report on Form 10-Q.

Previous wording

In the six months ended June 30, 2025, we used $109.2 million of cash in operating activities, attributable to a net loss of $128.2 million, offset by adjustments for non-cash charges of $14.3 million, $0.8 million in license fees attributable to investing activities, and a decrease in our net operating assets and liabilities of $3.9 million. Non-cash charges primarily consisted of $17.2 million of stock-based compensation, non-cash interest income of $4.4 million related to amortization of discount on purchases of marketable securities, and a $0.9 million reduction in the carrying amount of operating lease right-of-use assets. The change in our net operating assets and liabilities was primarily due to an increase of $3.3 million in accrued and other current liabilities, an increase of $5.5 million in accounts payable, an increase of $4.2 million in prepaid expense and other current assets, and a decrease of $0.9 million in operating lease liabilities.

Current wording

In the nine months ended September 30, 2025, we used $171.1 million of cash in operating activities, attributable to a net loss of $208.5 million, offset by adjustments for non-cash charges of $24.0 million, $0.8 million in license fees attributable to investing activities, and a decrease in our net operating assets and liabilities of $12.6 million. Non-cash charges primarily consisted of $27.0 million of stock-based compensation, non-cash interest income of $5.9 million related to amortization of discount on purchases of marketable securities, and a $1.3 million reduction in the carrying amount of operating lease right-of-use assets. The change in our net operating assets and liabilities was primarily due to an increase of $7.2 million in accrued and other current liabilities, an increase of $10.3 million in accounts payable, an increase of $3.6 million in prepaid expense and other current assets, and a decrease of $1.4 million in operating lease liabilities.

Previous wording

In the six months ended June 30, 2024, we used $58.6 million of cash in operating activities, attributable to a net loss of $62.1 million, $4.5 million of non-cash interest income and an increase in our net operating assets and liabilities of $2.5 million, partially offset by non-cash operating expenses of $10.4 million. Non-cash charges primarily consisted of $9.0 million of stock-based compensation expense and a $1.0 million reduction in the carrying amount of operating lease right-of-use assets. The net change in operating assets and liabilities was primarily due to a decrease of $6.5 million in accounts payable and a decrease of $1.3 million in operating lease liabilities, partially offset by an increase in $2.9 million in accrued and other current liabilities and a decrease of $2.3 million in prepaid expense and other current assets.

Current wording

In the nine months ended September 30, 2024, we used $95.5 million of cash in operating activities, attributable to a net loss of $108.7 million and $6.9 million of non-cash interest income related to amortization of discount on purchases of marketable securities, partially offset by non-cash operating expenses of $16.1 million and a net change in operating assets and liabilities of $3.4 million. Non-cash operating expenses primarily consisted of $14.6 million of stock-based compensation and a $1.5 million reduction in the carrying amount of operating lease right-of-use assets. The net change in operating assets and liabilities was primarily due to an increase of $11.0 million in accrued and other current liabilities, partially offset by a decrease of $6.5 million in accounts payable and a decrease of $1.9 million in operating lease liabilities.

Previous wording

The increase in cash used in operating activities from the six months ended June 30, 2024 to the six months ended June 30, 2025 was primarily attributable to increased research and development and general and administrative expenses.

Current wording

The increase in cash used in operating activities from the nine months ended September 30, 2024 to the nine months ended September 30, 2025 was primarily attributable to increased research and development and general and administrative expenses.

Previous wording

In the six months ended June 30, 2025, our investing activities provided $43.9 million of cash, primarily resulting from $187.3 million for purchases of marketable securities, offset by $232.3 million provided by maturities of marketable securities.

Current wording

In the nine months ended September 30, 2025, our investing activities provided $113.6 million of cash, primarily resulting from $400.9 million provided by maturities of marketable securities, offset by $285.9 million used for purchases of marketable securities.

Previous wording

In the six months ended June 30, 2024, our investing activities used $242.0 million of cash, primarily resulting from $336.1 million for purchases of marketable securities, offset by $94.2 million provided by sales and maturities of marketable securities.

Current wording

In the nine months ended September 30, 2024, our investing activities used $203.6 million of cash, primarily resulting from $409.0 million for purchases of marketable securities, offset by $205.7 million provided by sales and maturities of marketable securities.

Previous wording

In the six months ended June 30, 2025, our financing activities provided $21.8 million of cash, resulting from $23.3 million in net proceeds from borrowings from the initial funding under the 2025 Loan Agreement in June 2025, after repayment of borrowings under the 2021 Loan Agreement, $2.0 million in proceeds from exercise of stock options and issuance of shares under our employee stock purchase plan, and $3.5 million in payment of deferred issuance costs related to unfunded loan commitments under the 2025 Loan Agreement.

Current wording

In the nine months ended September 30, 2025, our financing activities provided $22.6 million of cash, resulting from $23.3 million in net proceeds from borrowings from the initial funding under the 2025 Loan Agreement in June 2025, after repayment of borrowings under the 2021 Loan Agreement, and $2.8 million in proceeds from exercise of stock options and issuance of shares under our employee stock purchase plan, offset by $3.5 million in payment of deferred issuance costs related to unfunded loan commitments under the 2025 Loan Agreement.

Previous wording

In the six months ended June 30, 2024, our financing activities provided $280.0 million of cash, resulting from $287.5 million of gross proceeds from our February 2024 follow-on offering, $10.4 million of proceeds from exercise of stock options and issuance of shares under our employee stock purchase plan, partially offset by payment of $17.9 million in offering costs related to the February 2024 follow-on offering, including underwriting fees.

Current wording

In the nine months ended September 30, 2024, our financing activities provided $280.7 million of cash, resulting from $287.5 million in gross proceeds from our February 2024 follow-on offering, $11.1 million proceeds from exercise of stock options and issuance of shares under our employee stock purchase plan, partially offset by $17.9 million of costs and underwriting discounts and commissions related to our February 2024 follow-on offering.

Previous wording

During the six months ended June 30, 2025, there were no material changes to our contractual obligations and commitments from those described under “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in the Annual Report.

Current wording

During the nine months ended September 30, 2025, there were no material changes to our contractual obligations and commitments from those described under “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in the Annual Report.

Previous wording

Our critical accounting policies are described in the section titled “Management’s Discussion and Analysis of Financial Condition and Results of Operations – Critical Accounting Policies and Significant Judgments and Estimates” in the Annual Report and the notes to our unaudited condensed financial statements appearing elsewhere in this Quarterly Report on Form 10-Q. During the six months ended June 30, 2025, there were no material changes to our critical accounting policies and estimates from those discussed in the Annual Report.

Current wording

Our critical accounting policies are described in the section titled “Management’s Discussion and Analysis of Financial Condition and Results of Operations – Critical Accounting Policies and Significant Judgments and Estimates” in the Annual Report and the notes to our unaudited condensed financial statements appearing elsewhere in this Quarterly Report on Form 10-Q. During the nine months ended September 30, 2025, there were no material changes to our critical accounting policies and estimates from those discussed in the Annual Report.