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Vera Therapeutics to Host an Investor Call and Webcast to Provide an ORIGIN 3 Update on November 6, 2025 at 4:30 pm ET
Globenewswire· 2025-10-22 12:00
BRISBANE, Calif., Oct. 22, 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 announced that it will host an investor call and webcast at 4:30 PM ET on Thursday, November 6, 2025 to review the data from the ORIGIN Phase 3 clinical trial of atacicept for the treatment of IgA nephropathy (IgAN) presented at the morning plenary ses ...
BofA Initiates Coverage of Vera Therapeutics (VERA) With a Buy Rating
Insider Monkey· 2025-10-21 03:08
Core Insights - Artificial intelligence (AI) is identified as the greatest investment opportunity of the current era, with a strong emphasis on the urgent need for energy to support its growth [1][2][3] - A specific company is highlighted as a key player in the AI energy sector, owning critical energy infrastructure assets that are essential for meeting the increasing energy demands of AI technologies [3][7] Investment Landscape - Wall Street is investing hundreds of billions into AI, but there is a pressing concern regarding the energy supply needed to sustain this growth [2] - AI data centers consume energy equivalent to that of small cities, leading to a strain on global power grids and rising electricity prices [2][3] - The company in focus is positioned to capitalize on the surge in demand for electricity driven by AI advancements [3][6] Company Profile - The company is described as a "toll booth" operator in the AI energy boom, benefiting from the increasing need for energy infrastructure [4][5] - It is involved in the U.S. LNG exportation sector, which is expected to grow significantly under the current administration's energy policies [7] - The company is noted for its capability in executing large-scale engineering, procurement, and construction projects across various energy sectors, including nuclear energy [7][8] Financial Position - The company is completely debt-free and has a substantial cash reserve, amounting to nearly one-third of its market capitalization [8] - It is trading at a low valuation of less than 7 times earnings, making it an attractive investment opportunity compared to other energy and utility firms [10][11] Market Trends - The ongoing AI infrastructure supercycle, combined with the onshoring boom and a surge in U.S. LNG exports, positions the company favorably in the market [14] - The influx of talent into the AI sector is expected to drive continuous innovation and advancements, further solidifying the importance of energy infrastructure [12][13]
Vera Therapeutics Announces ORIGIN 3 Late-Breaking Abstract Selected as Featured Oral Presentation at Opening Plenary Session of ASN Kidney Week 2025
Globenewswire· 2025-10-17 13:12
BRISBANE, Calif., Oct. 17, 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 announced that data from the ORIGIN Phase 3 clinical trial of atacicept for the treatment of IgA nephropathy (IgAN) will be delivered as a featured late-breaking oral presentation during the opening plenary session of the American Society of Nephrology ...
Stocks of possible M&A targets have been crushing the market. Goldman says these 6 are the most likely to get bought.
Yahoo Finance· 2025-09-30 17:15
Group 1 - Mergers and acquisitions (M&A) activity has increased significantly in 2025, with a 29% rise in deal value year-over-year and an 8% increase in the number of deals [3][4] - Electronic Arts is set to be taken private in the largest leveraged buyout ever, resulting in a stock price increase of over 20% in two days following the announcement [1] - Goldman Sachs predicts a further 15% growth in the number of M&A deals in 2026, driven by improving economic conditions and CEO confidence [4] Group 2 - A basket of potential M&A candidates has outperformed the S&P 1500 by seven percentage points since early September [2] - Goldman Sachs has identified six stocks with a 30% to 50% chance of being acquired in the next 12 months, highlighting their potential as M&A targets [3][4] - The identified stocks include companies from the health care sector, such as Insmed, Madrigal Pharmaceuticals, Krystal Biotech, Mineralys Therapeutics, and Vera Therapeutics, with varying market capitalizations and year-to-date total returns [5][6][7][8][9]
6 Stocks Poised For Potential Acquisition In The Next 12 Months, According To Goldman Sachs, Including A 200% YTD Gainer - (AACT), Walt Disney (NYSE:DIS)
Benzinga· 2025-09-30 13:11
Goldman Sachs has highlighted six stocks that have a high probability of being acquisition targets in the next year.Six Stocks Seen as Likely M&A Targets By GoldmanThe bank reported that the total dollar value of M&A deals has risen 29% year-over-year, with deal volumes in 2025 climbing 8%. The bank projects an additional 15% increase in new deals in 2026.Goldman’s Chief U.S. equity strategist, David Kostin, in a note on Monday, identified six stocks with a 30% to 50% chance of being acquired in the next 12 ...
Vera Therapeutics, Inc. (VERA) Presents at Cantor Global Healthcare Conference 2025 Transcript
Seeking Alpha· 2025-09-05 09:45
Company Overview - Vera Therapeutics is a public biotech company based in San Francisco, founded by Marshall Fordyce, who serves as the CEO [4]. - The company has been operational for about 4 years and has made significant progress with its lead product candidate, atacicept, which is an immune modulator targeting B-cell-driven diseases [4]. Product Development - Vera Therapeutics recently completed a Phase III trial for atacicept, specifically addressing IgA Nephropathy, a major unmet medical need [4]. - The company plans to file for a Biologics License Application (BLA) in the fourth quarter of this year, with expectations to be on the market by mid-next year [4]. Market Potential - The management team believes that the kidney community is on the brink of a new era in managing patients with IgA Nephropathy and other related conditions [5].
Vera Therapeutics (VERA) 2025 Conference Transcript
2025-09-04 14:10
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.
Vera Therapeutics Announces Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)
Globenewswire· 2025-08-08 20:05
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 (VERA) Q2 Net Loss Widens 127%
The Motley Fool· 2025-08-06 06:05
Core Viewpoint - Vera Therapeutics reported a widening net loss of $76.5 million for Q2 2025, significantly exceeding analyst expectations, while also achieving revenue of $76.5 million, indicating increased spending as the company approaches regulatory filing for its lead drug candidate [1][5][6]. Financial Performance - The GAAP net loss increased by approximately 127% year-over-year, from $33.7 million in Q2 2024 to $76.5 million in Q2 2025 [2][5]. - The loss per share (GAAP) was $1.20, a significant increase from $0.62 in Q2 2024, reflecting a rapid rise in spending [6]. - Research and development expenses nearly doubled to $58.2 million from $29.3 million in Q2 2024, driven by costs associated with late-stage clinical trials and preparations for commercialization [2][6]. Business Overview - Vera Therapeutics is focused on developing therapies for serious immunological diseases, particularly Immunoglobulin A Nephropathy (IgAN), with its lead drug candidate, atacicept, designed to modify the disease course [3][9]. - The company is preparing for a pivotal Phase 3 ORIGIN trial outcome, which is crucial for a future submission to the FDA for accelerated approval [4][9]. Clinical Developments - Positive results from the ORIGIN Phase 3 trial showed a 46% reduction in proteinuria at 36 weeks, with a favorable safety profile for atacicept, reinforcing plans for a Biologics License Application (BLA) submission in Q4 2025 [7][9]. - Vera has initiated the PIONEER study to test atacicept in other kidney diseases, indicating ambitions to expand the drug's impact and revenue potential [8][12]. Strategic Initiatives - The company is building a specialized commercial team with nephrology expertise to facilitate the transition from clinical success to market adoption [10]. - Vera secured a new credit facility of up to $500 million, alongside $556.8 million in cash and equivalents, to support operations through the anticipated approval and launch of atacicept [11]. Future Outlook - Management emphasized near-term milestones, including the planned BLA submission for atacicept and expected initial results from the PIONEER trial later in the year [13][14]. - The company does not currently pay a dividend, focusing resources on advancing its clinical and commercial strategies [14].
Vera Therapeutics(VERA) - 2025 Q2 - Quarterly Report
2025-08-05 20:06
[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)