Presentation Pete StavropoulosBiotech Analyst So welcome to the Cantor Global Healthcare Conference. I'm Pete Stavropoulos, a biotech analyst with Cantor. With us, we have Vera Therapeutics, a company I cover, and I'm pleased to introduce Marshall Fordyce and CEO; and Robert Brenner, CMO. Welcome. Marshall FordyceFounder, President, CEO & Director Thanks so much, Pete. Great to be here. Pete StavropoulosBiotech Analyst Let's start off with a brief intro for those that don't know who you are... Marsh ...

Summary of Vera Therapeutics Conference Call Company Overview - **Company**: Vera Therapeutics (VERA) - **Industry**: Biotechnology, specifically focused on autoimmune kidney diseases - **Lead Product**: Atacicept, an immune modulator for B cell driven diseases, particularly IgA nephropathy Key Points and Arguments 1. **Product Development and Market Entry** - Vera Therapeutics plans to file for a Biologics License Application (BLA) in Q4 2025, with expectations to be on the market by mid-2026 [3][4][44] 2. **Unmet Medical Need** - There are approximately 160,000 patients in the U.S. with biopsy-proven IgA nephropathy, with at least half at high risk of disease progression [8][12] - Diagnosis is often delayed until around age 35, leading to urgent treatment needs as patients may require dialysis before age 50 if untreated [9][12] 3. **Clinical Trial Data** - Phase III trial showed a 46% reduction in proteinuria in the active group, significantly exceeding the FDA's 30% threshold for approval [22] - The GFR (glomerular filtration rate) data from the Phase II and interim Phase III trials indicate a potential to prevent the need for dialysis or transplant [25][27] 4. **Mechanism of Action** - Atacicept targets B cells, reducing the formation of immune complexes that lead to kidney inflammation and damage [16][17] - The drug is designed for self-administration via a low-volume auto-injector, enhancing patient convenience [43][57] 5. **Commercialization Strategy** - The company has been actively engaging with the nephrology community and has established a sales leadership team to prepare for the U.S. launch [50][51] - Early feedback indicates strong awareness and understanding of Atacicept among nephrologists [51] 6. **Regulatory Outlook** - The company is optimistic about receiving priority review from the FDA, based on the quality of their data and collaborative discussions with the agency [44][49] 7. **Pipeline and Future Studies** - Vera is exploring additional indications beyond IgA nephropathy, including membranous nephropathy and other autoimmune kidney diseases [59][60] - A study for monthly dosing of Atacicept is ongoing, with updates expected once the optimal dose is identified [55] Additional Important Information - **Patient Engagement** - Vera has been actively involved with patient advocacy groups, such as the IGAN Foundation, to better understand patient needs and improve treatment outcomes [53][54] - **Long-term Vision** - The company aims to transform the management of autoimmune kidney diseases and is focused on building a strong pipeline for future therapies [64] - **Acquisition** - Vera announced the acquisition of VT-109, a novel fusion protein, which is expected to complement their existing product offerings [56] This summary encapsulates the critical insights from the conference call, highlighting Vera Therapeutics' strategic direction, clinical advancements, and market potential in the biotechnology sector focused on kidney diseases.

Core Insights - Vera Therapeutics, Inc. granted inducement awards to eight new employees, including non-qualified stock options for 99,000 shares and restricted stock units (RSUs) for 48,200 shares under the 2024 Inducement Plan [1][2] Group 1: Inducement Awards - The stock options have an exercise price of $20.45, which is the closing trading price on August 4, 2025 [2] - Stock options will vest over four years, with 25% vesting on the first anniversary and the remaining shares vesting monthly over the next 36 months [2] - RSUs will also vest over four years, with 25% vesting on each anniversary of August 20, 2025 [2] Group 2: Company Overview - Vera Therapeutics is a late clinical-stage biotechnology company focused on treatments for serious immunological diseases [3] - The lead product candidate, atacicept, is designed to block BAFF and APRIL, which are involved in autoimmune diseases like immunoglobulin A nephropathy and lupus nephritis [3] - Vera is also developing MAU868, a monoclonal antibody targeting BK virus infections, and holds global rights to atacicept and MAU868 [3]

Vera Therapeutics (VERA 1.37%), a biotechnology company developing treatments for serious immunologic diseases, released results for the quarter on August 5, 2025. The most notable news was its widening net loss to $76.5 million, or $1.20 per share (GAAP), compared to analyst expectations for a GAAP loss of $0.82 per share. While the company posted headline revenue of $76.5 million (GAAP). Results show accelerated spending as the company moves closer to a planned regulatory filing for its lead drug candidat ...

[Summary of Risks Associated with Our Business](index=3&type=section&id=SUMMARY%20OF%20RISKS%20ASSOCIATED%20WITH%20OUR%20BUSINESS) The company's primary risks include substantial dependence on clinical-stage product candidates, significant capital requirements, a history of net losses, and operational and intellectual property challenges - The company's primary risks include its substantial dependence on the success of its clinical-stage product candidates (atacicept, MAU868, and VT-109), the need for significant additional capital to fund operations, and a history of incurring net losses since inception[10](index=10&type=chunk) - Key operational risks involve potential difficulties in clinical trial enrollment and retention, significant competition from other companies, reliance on third parties for manufacturing and clinical trials, and the potential for manufacturing or formulation changes to cause delays[10](index=10&type=chunk)[11](index=11&type=chunk) - Intellectual property and strategic risks include the need to protect proprietary technologies, potential loss of rights if license agreements are breached, and the volatility of the company's common stock price[10](index=10&type=chunk)[11](index=11&type=chunk) [PART I. FINANCIAL INFORMATION](index=5&type=section&id=PART%20I.%20FINANCIAL%20INFORMATION) This section presents the company's unaudited condensed financial statements and management's discussion and analysis of financial condition [Item 1. Condensed Financial Statements (Unaudited)](index=5&type=section&id=Item%201.%20Condensed%20Financial%20Statements%20%28Unaudited%29) The company reported increased net losses for Q2 and H1 2025, driven by higher expenses, while maintaining a strong cash position of $556.8 million [Condensed Balance Sheets](index=5&type=section&id=Condensed%20Balance%20Sheets) Total assets decreased to $578.5 million, liabilities increased to $110.3 million due to new debt, and stockholders' equity declined to $468.3 million Condensed Balance Sheet Highlights (in thousands) | Balance Sheet Item | June 30, 2025 (unaudited) | December 31, 2024 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $49,121 | $92,646 | | Marketable securities | $507,706 | $548,206 | | **Total Assets** | **$578,528** | **$655,681** | | **Liabilities** | | | | Total current liabilities | $33,554 | $25,371 | | Long-term debt | $74,464 | $50,687 | | **Total Liabilities** | **$110,251** | **$78,526** | | **Total Stockholders' Equity** | **$468,277** | **$577,155** | [Condensed Statements of Operations and Comprehensive Loss](index=6&type=section&id=Condensed%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) Net loss significantly increased to $76.5 million for Q2 2025 and $128.2 million for H1 2025, primarily due to substantial rises in R&D and G&A expenses Statement of Operations Summary (in thousands, except per share data) | Metric | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--- | :--- | :--- | :--- | :--- | | Research and development | $58,195 | $29,311 | $99,473 | $52,511 | | General and administrative | $21,946 | $8,032 | $37,862 | $15,944 | | Loss from operations | $(80,141) | $(37,343) | $(137,335) | $(68,455) | | **Net loss** | **$(76,531)** | **$(33,708)** | **$(128,225)** | **$(62,091)** | | Net loss per share | $(1.20) | $(0.62) | $(2.01) | $(1.17) | [Condensed Statements of Stockholders' Equity](index=7&type=section&id=Condensed%20Statements%20of%20Stockholders%27%20Equity) Total stockholders' equity decreased by $108.9 million to $468.3 million as of June 30, 2025, primarily due to the period's net loss - Stockholders' equity decreased by **$108.9 million** in the first six months of 2025, falling from **$577.2 million** to **$468.3 million**, mainly due to the period's net loss[20](index=20&type=chunk) [Condensed Statements of Cash Flows](index=8&type=section&id=Condensed%20Statements%20of%20Cash%20Flows) Net cash used in operations increased to $109.2 million for H1 2025, while investing and financing activities provided cash, resulting in a $43.5 million decrease in cash and equivalents Cash Flow Summary (in thousands) | Cash Flow Activity | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | $(109,204) | $(58,612) | | Net cash provided by (used in) investing activities | $43,861 | $(241,963) | | Net cash provided by financing activities | $21,818 | $279,979 | | **Net decrease in cash and cash equivalents** | **$(43,525)** | **$(20,596)** | | **Cash and cash equivalents, end of period** | **$49,121** | **$25,085** | [Notes to Condensed Financial Statements](index=9&type=section&id=Notes%20to%20Condensed%20Financial%20Statements) The notes detail the company's $556.8 million liquidity, a new $500 million loan agreement, and the acquisition of preclinical compound VT-109 - As of June 30, 2025, the company had cash, cash equivalents, and marketable securities of **$556.8 million**, which management believes are sufficient to support planned operations for at least the next 12 months[27](index=27&type=chunk)[28](index=28&type=chunk) - In June 2025, the company entered into a new loan agreement with a total borrowing capacity of up to **$500.0 million**, of which **$75.0 million** was funded at closing, with proceeds partly used to repay the previous 2021 Loan Agreement[49](index=49&type=chunk) - In January 2025, the company acquired worldwide development and commercial rights to VT-109, a preclinical fusion protein, from Stanford University for license issue fees of **$0.8 million** plus potential future milestones and royalties[65](index=65&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=22&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses progress on atacicept's Phase 3 trial and Q4 2025 submission plans, alongside increased Q2 2025 net losses driven by higher R&D and G&A expenses [Overview](index=22&type=section&id=Overview) Vera Therapeutics, a late clinical-stage biotech, completed enrollment for its pivotal atacicept Phase 3 trial, with a regulatory submission planned for Q4 2025, while expecting continued operating losses - The company's lead product candidate, atacicept, is being evaluated for IgAN, with the pivotal Phase 3 trial (ORIGIN 3) completing full enrollment in April 2025, and primary endpoint results announced in Q2 2025 supporting a planned regulatory submission[81](index=81&type=chunk) - A regulatory submission for atacicept is planned for the **fourth quarter of 2025**[81](index=81&type=chunk) - The company's pipeline also includes MAU868 for reactivated BK virus (BKV) infections and VT-109, a next-generation dual BAFF/APRIL inhibitor in preclinical development[81](index=81&type=chunk) [Results of Operations](index=26&type=section&id=Results%20of%20Operations) Total operating expenses increased to $80.1 million in Q2 2025, driven by significant rises in R&D (99%) and G&A (173%) expenses due to clinical and commercial activities Comparison of Operating Expenses (in thousands) | Expense Category | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Change | | :--- | :--- | :--- | :--- | | Research and development | $58,195 | $29,311 | $28,884 | | General and administrative | $21,946 | $8,032 | $13,914 | | **Total operating expenses** | **$80,141** | **$37,343** | **$42,798** | - The **99%** year-over-year increase in Q2 R&D expenses was primarily due to a **$10.7 million** increase in contract drug manufacturing, a **$5.8 million** increase in clinical trial expenses, and an **$8.2 million** increase in employee compensation due to headcount growth[96](index=96&type=chunk) - The **173%** year-over-year increase in Q2 G&A expenses was mainly driven by a **$6.5 million** increase in employee compensation and a **$3.8 million** increase in commercial planning and medical affairs expenses in preparation for potential regulatory approval[101](index=101&type=chunk) [Liquidity and Capital Resources](index=29&type=section&id=Liquidity%20and%20Capital%20Resources) The company held $556.8 million in liquidity, refinanced debt with a new $500 million loan, and used $109.2 million in cash for operations in H1 2025 - The company held **$556.8 million** in cash, cash equivalents, and marketable securities as of June 30, 2025, which is believed to be sufficient to fund operations for at least the next 12 months[111](index=111&type=chunk) - In June 2025, the company entered into a new loan agreement for up to **$500.0 million**, drawing an initial **$75.0 million**, with net proceeds of approximately **$23.3 million** after repaying existing debt[107](index=107&type=chunk)[124](index=124&type=chunk) Cash Flow Summary (in thousands) | Cash Flow Activity | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | $(109,204) | $(58,612) | | Net cash provided by (used in) investing activities | $43,861 | $(241,963) | | Net cash provided by financing activities | $21,818 | $279,979 | [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=34&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company's market risks primarily involve interest rate sensitivity and concentration of cash at a single financial institution, with foreign currency and inflation risks deemed minimal - The company is exposed to interest rate risk through its investment portfolio and its variable-rate 2025 Loan Agreement, however, management does not believe a **1.0%** change in interest rates would have a material impact on its financial condition[134](index=134&type=chunk)[135](index=135&type=chunk) - Substantially all of the company's cash is held with a single financial institution, which may exceed FDIC insured limits, representing a concentration of credit risk[136](index=136&type=chunk) - Foreign currency exchange risk and the effects of inflation are not considered to have had a material effect on the company's business or financial results during the periods presented[138](index=138&type=chunk)[139](index=139&type=chunk) [Item 4. Controls and Procedures](index=36&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were effective as of June 30, 2025, with no material changes to internal control over financial reporting - Management, including the CEO and CFO, concluded that as of June 30, 2025, the company's disclosure controls and procedures were effective[141](index=141&type=chunk) - No changes in internal control over financial reporting that have materially affected, or are reasonably likely to materially affect, such controls were identified during the quarter ended June 30, 2025[142](index=142&type=chunk) [PART II. OTHER INFORMATION](index=37&type=section&id=PART%20II.%20OTHER%20INFORMATION) This section provides additional information including legal proceedings, detailed risk factors, and other required disclosures [Item 1. Legal Proceedings](index=37&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently a party to any material legal proceedings - As of the filing date, the company is not a party to any material legal proceedings[144](index=144&type=chunk) [Item 1A. Risk Factors](index=37&type=section&id=Item%201A.%20Risk%20Factors) This section outlines significant risks including reliance on product candidates, need for funding, regulatory uncertainty, intense competition, third-party dependence, and intellectual property protection [Risks related to financial position and need for additional capital](index=37&type=section&id=Risks%20related%20to%20our%20financial%20position%20and%20need%20for%20additional%20capital) The company faces risks from its limited operating history, ongoing net losses, accumulated deficit of $589.5 million, and the need for substantial additional capital - The company will require substantial additional capital to finance its operations and may be forced to delay or eliminate research and development programs if unable to raise funds on acceptable terms[148](index=148&type=chunk) - The company has incurred net losses since inception, with an accumulated deficit of **$589.5 million** as of June 30, 2025, and expects to continue incurring losses for the foreseeable future[152](index=152&type=chunk) [Risks related to discovery, development and commercialization](index=43&type=section&id=Risks%20related%20to%20the%20discovery%2C%20development%20and%20commercialization%20of%20our%20product%20candidates) Future success depends heavily on clinical-stage candidates, facing risks from lengthy, uncertain, and costly development, potential trial delays, and significant competition - The company is substantially dependent on the success of its product candidates, atacicept, MAU868, and VT-109, which are in clinical or pre-clinical development[161](index=161&type=chunk) - Clinical development is a lengthy, expensive process with an uncertain outcome, and results of earlier studies may not predict future trial results, with failure possible at any stage[163](index=163&type=chunk) - The company faces significant competition in the IgAN space from approved products such as TARPEYO, FILSPARI, FABHALTA, and VANRAFIA, as well as numerous programs in late-stage development[176](index=176&type=chunk)[190](index=190&type=chunk) [Risks related to regulatory approval and legal compliance](index=52&type=section&id=Risks%20related%20to%20regulatory%20approval%20and%20other%20legal%20compliance%20matters) The company faces risks from lengthy and unpredictable regulatory approval, market acceptance, pricing and reimbursement challenges, healthcare reform, and complex data privacy compliance - The regulatory approval process is lengthy, time-consuming, and inherently unpredictable, and failure to obtain approval would significantly harm the business[195](index=195&type=chunk) - Successful commercialization depends on obtaining adequate coverage and reimbursement from governmental and private payors, which is uncertain and subject to cost-containment pressures[231](index=231&type=chunk)[232](index=232&type=chunk) - The company is subject to stringent and evolving U.S. and foreign data privacy and security laws (e.g., GDPR, CCPA), and non-compliance could lead to significant fines, litigation, and reputational harm[262](index=262&type=chunk)[263](index=263&type=chunk) [Risks related to intellectual property](index=89&type=section&id=Risks%20related%20to%20our%20intellectual%20property) Success depends on intellectual property protection, facing risks of patent invalidation or insufficient coverage, and potential loss of rights from license agreement breaches - Commercial success depends on the ability to obtain and maintain proprietary protection for product candidates, with no assurance that patents will be issued or that they will provide sufficient protection[307](index=307&type=chunk)[308](index=308&type=chunk) - A breach of the license agreements with Ares (atacicept), Novartis (MAU868), or Stanford (VT-109) could result in the loss of the ability to continue development and commercialization of these respective product candidates[317](index=317&type=chunk) - Patent terms may be inadequate to protect the company's competitive position for a sufficient amount of time, as patents may expire before or shortly after product commercialization[364](index=364&type=chunk) [Risks related to dependence on third parties](index=113&type=section&id=Risks%20related%20to%20our%20dependence%20on%20third%20parties) The company heavily relies on third parties for clinical trials and manufacturing, introducing risks of non-performance, regulatory non-compliance, and supply delays - The company relies on third-party CROs to conduct clinical trials and is responsible for ensuring their compliance with GCP and other regulations, where failure by CROs to perform could delay or terminate trials[392](index=392&type=chunk)[393](index=393&type=chunk) - The company lacks internal manufacturing capabilities and relies on third-party manufacturers for its product candidates, increasing the risk of supply delays, quality issues, and lack of control over the manufacturing process[399](index=399&type=chunk) - Future collaborations for development and commercialization are not guaranteed and, if unsuccessful, could prevent the company from capitalizing on the market potential of its product candidates[409](index=409&type=chunk) [Risks related to ownership of Class A common stock](index=123&type=section&id=Risks%20related%20to%20ownership%20of%20our%20Class%20A%20common%20stock) The company's stock price is highly volatile, with significant control held by principal stockholders, and corporate provisions could deter acquisitions - The trading price of the company's common stock has been and is likely to be highly volatile[417](index=417&type=chunk) - Executive officers, directors, and stockholders owning over **5%** of the company's stock beneficially own a significant percentage, enabling them to exert substantial control over matters requiring stockholder approval[426](index=426&type=chunk) - Provisions in the company's amended and restated certificate of incorporation and bylaws, as well as Delaware law, could make an acquisition of the company more difficult[435](index=435&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=136&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The 2025 Loan Agreement restricts the company's ability to pay dividends without prior lender consent - The terms of the 2025 Loan Agreement restrict the company's ability to pay dividends without prior written consent from Oxford[467](index=467&type=chunk) [Item 3. Defaults Upon Senior Securities](index=136&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) The company reports no defaults upon senior securities - None[468](index=468&type=chunk) [Item 4. Mine Safety Disclosures](index=136&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company - Not applicable[469](index=469&type=chunk) [Item 5. Other Information](index=136&type=section&id=Item%205.%20Other%20Information) The company reports no other information - None[470](index=470&type=chunk) [Item 6. Exhibits](index=137&type=section&id=Item%206.%20Exhibits) This section lists exhibits filed with the Quarterly Report, including the Loan and Security Agreement and officer certifications - Key exhibits filed include the Loan and Security Agreement dated June 2, 2025, and certifications from the Principal Executive Officer and Principal Financial Officer[472](index=472&type=chunk)

[Business Update and Highlights](index=1&type=section&id=Business%20Update%20and%20Highlights) Vera Therapeutics achieved significant clinical and corporate progress in Q2 2025, including positive ORIGIN 3 trial results for atacicept in IgAN, leading to a planned BLA submission in Q4 2025 and potential 2026 launch [Q2 2025 and Recent Business Highlights](index=1&type=section&id=Q2%202025%20and%20Recent%20Business%20Highlights) Vera achieved a major clinical milestone in Q2 2025 with positive 36-week ORIGIN 3 trial data for atacicept in IgAN, showing a 42% UPCR reduction and leading to BLA preparation - The company is on track to submit a Biologics License Application (BLA) for accelerated approval of atacicept to the U.S. FDA in **Q4 2025**, targeting a potential commercial launch in **2026**[3](index=3&type=chunk)[5](index=5&type=chunk) ORIGIN 3 Trial 36-Week Key Results | Metric | Result vs. Placebo | p-value | | :--- | :--- | :--- | | **Primary Endpoint (UPCR Reduction)** | 42% reduction | p<0.0001 | | **Proteinuria Reduction (from baseline)** | 46% reduction | N/A | - The safety profile of atacicept across the ORIGIN program was reported as favorable and comparable to placebo[6](index=6&type=chunk) - Initiated the PIONEER trial to investigate atacicept in a broader IgAN patient cohort and other autoimmune glomerular diseases[5](index=5&type=chunk) [Anticipated Upcoming Milestones](index=2&type=section&id=Anticipated%20Upcoming%20Milestones) Vera Therapeutics anticipates key milestones in late 2025, including BLA submission for atacicept, full ORIGIN 3 trial results, and initial PIONEER trial results, supported by a new $500 million credit facility - Key upcoming events for late 2025 include: * Submission of a BLA for atacicept in IgAN to the U.S. FDA in **Q4 2025** * Presentation of full 36-week results from the pivotal ORIGIN 3 trial in **Q4 2025** * Initial results from the PIONEER Phase 2 basket trial expected in **Q4 2025**[10](index=10&type=chunk) - The pivotal ORIGIN 3 study is expected to be completed in **2027**[10](index=10&type=chunk) - The company secured a new credit facility of up to **$500 million**, extending its cash runway well beyond the potential commercial launch of atacicept[10](index=10&type=chunk) [Financial Performance](index=2&type=section&id=Financial%20Performance) Vera Therapeutics reported a net loss of $76.5 million for Q2 2025 and increased cash usage, yet maintains a strong balance sheet with $556.8 million in cash, expected to fund operations through atacicept's potential U.S. launch Q2 2025 Financial Highlights (in thousands) | Metric | Q2 2025 | Q2 2024 | | :--- | :--- | :--- | | **Net Loss** | $76,500 | $33,700 | | **Net Loss per Diluted Share** | $1.20 | $0.62 | Six Months Ended June 30 Cash Flow (in thousands) | Metric | 2025 | 2024 | | :--- | :--- | :--- | | **Net Cash Used in Operating Activities** | $109,200 | $58,600 | - As of June 30, 2025, the company reported **$556.8 million** in cash, cash equivalents, and marketable securities[8](index=8&type=chunk) [Product Pipeline and Corporate Overview](index=2&type=section&id=Product%20Pipeline%20and%20Corporate%20Overview) Vera Therapeutics is a late-stage clinical biotechnology company focused on immunological diseases, with lead candidate atacicept targeting IgAN and a pipeline including MAU868 and VT-109 [About Atacicept](index=2&type=section&id=About%20Atacicept) Atacicept is an investigational recombinant fusion protein targeting BAFF and APRIL, received FDA Breakthrough Therapy Designation for IgAN, and is positioned as a potential best-in-class therapy - Atacicept is an investigational recombinant fusion protein that binds to cytokines BAFF and APRIL, which promote B-cell survival and autoantibody production associated with certain autoimmune diseases[9](index=9&type=chunk) - The drug has received FDA Breakthrough Therapy Designation for the treatment of IgAN, reflecting its potential to demonstrate substantial improvement over available therapies[12](index=12&type=chunk) [About Vera Therapeutics](index=3&type=section&id=About%20Vera%20Therapeutics) Vera Therapeutics is a late clinical-stage biotechnology company developing treatments for immunological diseases, with lead product atacicept and a pipeline including MAU868 and VT-109, retaining global rights - Vera's lead product candidate is atacicept, a self-administered subcutaneous injection that blocks both BAFF and APRIL[13](index=13&type=chunk) - The company is also developing MAU868, a monoclonal antibody to neutralize BK virus (BKV) infection, which can have severe consequences in settings like kidney transplants[13](index=13&type=chunk) [Financial Statements](index=5&type=section&id=Financial%20Statements) The condensed financial statements show a significant increase in operating expenses, leading to a higher net loss for the second quarter and first half of 2025 compared to the prior year [Condensed Statements of Operations and Comprehensive Loss](index=5&type=section&id=Condensed%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) Total operating expenses for Q2 2025 increased to $80.1 million, driven by doubled R&D, resulting in a net loss of $76.5 million compared to $33.7 million in Q2 2024 Condensed Statement of Operations (Three Months Ended June 30, in thousands) | | 2025 | 2024 | | :--- | :--- | :--- | | Research and development | $58,195 | $29,311 | | General and administrative | $21,946 | $8,032 | | **Total operating expenses** | **$80,141** | **$37,343** | | **Net loss** | **$(76,531)** | **$(33,708)** | Condensed Statement of Operations (Six Months Ended June 30, in thousands) | | 2025 | 2024 | | :--- | :--- | :--- | | Research and development | $99,473 | $52,511 | | General and administrative | $37,862 | $15,944 | | **Total operating expenses** | **$137,335** | **$68,455** | | **Net loss** | **$(128,225)** | **$(62,091)** | [Condensed Balance Sheets](index=6&type=section&id=Condensed%20Balance%20Sheets) As of June 30, 2025, total assets decreased to $578.5 million due to reduced cash and marketable securities, while total liabilities increased to $110.3 million, primarily from higher long-term debt Condensed Balance Sheet Highlights (in thousands) | | June 30, 2025 | Dec 31, 2024 | | :--- | :--- | :--- | | **Assets** | | | | Cash, cash equivalents and marketable securities | $556,827 | $640,852 | | **Total assets** | **$578,528** | **$655,681** | | **Liabilities & Equity** | | | | Long-term debt | $74,464 | $50,687 | | **Total liabilities** | **$110,251** | **$78,526** | | **Total stockholders' equity** | **$468,277** | **$577,155** |

BRISBANE, Calif., Aug. 05, 2025 (GLOBE NEWSWIRE) -- Vera Therapeutics, Inc. (Nasdaq: VERA), a late clinical-stage biotechnology company focused on developing and commercializing transformative treatments for patients with serious immunological diseases, today reported its business highlights and financial results for the second quarter ended June 30, 2025. "Our team delivered exciting new clinical results from our pivotal ORIGIN 3 trial in the second quarter of 2025, which were consistent with or better tha ...

Efficacy Results - Atacicept demonstrated long-term stabilization of eGFR (estimated glomerular filtration rate) in IgAN patients over 96 weeks[31] - Atacicept treatment resulted in a sustained 66% reduction in Gd-IgA1 levels[20] - There was a notable 52% reduction in proteinuria (UPCR) with atacicept treatment over the 96-week study period[20] - Atacicept led to a 75% resolution of hematuria in treated participants[20] - The annualized eGFR slope with atacicept was -0.6 mL/min/1.73 m2 per year, comparable to the general population without kidney disease[20] Safety Profile - Atacicept was generally well-tolerated over 96 weeks, with an adverse event profile consistent with the initial 36-week randomized period[27] - During the double-blind phase, 73% of participants in the atacicept group experienced treatment-emergent adverse events (TEAEs)[27] - In the open-label extension (OLE) phase, 77% of participants experienced TEAEs[27] - Serious TEAEs were reported in 2% of participants during the double-blind phase and 11% during the OLE phase[27] - Discontinuation due to TEAEs occurred in 1% of participants during the double-blind phase and 2% during the OLE phase[27]

Industry Overview - The biopharmaceuticals industry presents both exciting opportunities and significant risks for investors, with leading growth stocks often emerging from this sector due to substantial rallies following positive trial results or government drug approvals [1][2] - Many biopharma firms face constant threats of collapse due to insufficient revenue, making breakthrough developments critical for their survival [2] Investment Strategies - Investors can balance their risk tolerance by relying on Wall Street analysts who specialize in the healthcare sector, potentially identifying high-potential investments before they gain mainstream recognition [3] Company Highlights: Kymera Therapeutics - Kymera Therapeutics Inc. focuses on developing small-molecule therapeutics to selectively degrade disease-causing proteins, with positive Phase 1 trial results for its flagship drug KT-621, aimed at treating moderate to severe atopic dermatitis [4][6] - The stock forecast for Kymera indicates a 12-month price target of $59.82, representing a 25.65% upside from the current price of $47.61, with 17 out of 18 analysts rating it as a Buy [5][7] - Kymera benefits from a robust pipeline and a partnership with AI-powered biopharma developer Sanofi, along with substantial cash reserves expected to sustain operations through 2028 [7] Company Highlights: Vera Therapeutics - Vera Therapeutics Inc. specializes in treatments for immunological diseases, with its leading candidate atacicept recently completing a positive Phase 3 trial for IgAN, positioning the company for potential FDA approval and a commercial launch by 2026 [9][10] - The stock forecast for Vera suggests a 12-month price target of $65.00, indicating a 193.45% upside from the current price of $22.15, with 9 out of 10 analysts rating it as a Buy [10][12] Company Highlights: Rapport Therapeutics - Rapport Therapeutics Inc. develops medicines for neurological and psychiatric disorders, with its candidate RAP-219 showing positive trial data for refractory focal epilepsy and plans for trials in bipolar mania [13][14] - The stock forecast for Rapport indicates a 12-month price target of $32.67, representing a 191.41% upside from the current price of $11.21, with all four analysts rating it as a Buy [14][15]

Financial Data and Key Metrics Changes - The company announced positive phase three results for Atacicept in the autoimmune kidney condition IgA nephropathy, with a 46% reduction in proteinuria from baseline, compared to a 7% reduction in the placebo group, resulting in a 42% adjusted effect [7][10][11] - The company plans to file its Biologics License Application (BLA) in the fourth quarter of this year, with a potential commercial launch in mid-2026 [8][9] Business Line Data and Key Metrics Changes - Atacicept is the only program in phase two and phase three studied as a home self-administered dose, with plans to deliver an auto-injector at potential commercial launch [5][6] - The company has two-year GFR data from phase two trials, showing that patients preserved kidney function while on Atacicept [6][8] Market Data and Key Metrics Changes - In the US, there are approximately 160,000 patients with biopsy-proven IgA nephropathy, with about 80,000 meeting the criteria for high risk of disease progression, representing a potential $10 billion market [10][11] - The company is well-positioned to capture a substantial portion of this market with strong phase three data [11] Company Strategy and Development Direction - The company aims to shift the treatment of autoimmune diseases from immune suppression to immune modulation, preserving safety while providing efficacy [4] - The company is expanding its research into other autoimmune kidney diseases and plans to conduct a basket trial for various IgA-mediated diseases [56][60] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in receiving priority review from the FDA due to the breakthrough designation already in hand [41][42] - The company is well-resourced with $590 million in cash and an expanded credit facility of up to $500 million, providing a total of $1 billion for commercialization and pipeline growth [62] Other Important Information - The company has been actively engaging with the nephrology community to raise awareness of Atacicept and its potential impact on treatment [40] - The management highlighted the importance of GFR as a key metric in discussions with payers, emphasizing the drug's potential to avoid costly dialysis [51] Q&A Session Summary Question: How representative is the trial population of typical IgA nephropathy patients? - The trial population was similar to the global burden of IgA nephropathy, with a mean age of about 39-40 years and significant proteinuria levels [13][14][15] Question: How does the use of concomitant therapies affect the trial results? - The use of concomitant therapies like SGLT2 inhibitors did not impact the primary endpoint of proteinuria reduction, indicating a high-risk population still in need of new treatments [17][18][19] Question: What are the key differences between the company's data and competitor data? - The company emphasized the importance of efficacy, safety, and patient convenience, noting that Atacicept is the only self-administered drug in its category [25][27] Question: What is the status of the PIONEER study? - The PIONEER study is exploring a broader range of patients with IgA-mediated diseases, aiming to provide insights across multiple populations [56][58] Question: How is the company preparing for commercialization? - The company has been preparing for commercialization for several years, with a focus on building a strong sales force and engaging with payers [42][44]