[PART I. FINANCIAL INFORMATION](index=6&type=section&id=PART%20I.%20FINANCIAL%20INFORMATION) Presents Metagenomi's unaudited condensed financial statements for Q2 and H1 2025, detailing financial position, operations, equity, and cash flows [Financial Statements (Unaudited)](index=6&type=section&id=Item%201.%20Financial%20Statements%20(Unaudited)) Presents Metagenomi's unaudited condensed financial statements for Q2 and H1 2025, including balance sheets, statements of operations, equity, and cash flows [Condensed Balance Sheets](index=6&type=section&id=Condensed%20Balance%20Sheets) Provides a snapshot of Metagenomi's financial position, including assets, liabilities, and stockholders' equity as of June 30, 2025, and December 31, 2024 Condensed Balance Sheet Highlights (in thousands) | Metric | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $26,850 | $27,386 | | Available-for-sale marketable securities | $178,143 | $220,921 | | Total current assets | $211,681 | $257,960 | | Total assets | $272,284 | $324,599 | | **Liabilities & Stockholders' Equity** | | | | Total current liabilities | $33,265 | $37,309 | | Total liabilities | $76,453 | $89,742 | | Accumulated deficit | $(267,949) | $(223,002) | | Total stockholders' equity | $195,831 | $234,857 | [Condensed Statements of Operations and Comprehensive Loss](index=7&type=section&id=Condensed%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) Details Metagenomi's financial performance, including revenue, expenses, and net loss for the three and six months ended June 30, 2025 and 2024 Statement of Operations Highlights (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 | | :--- | :--- | :--- | :--- | :--- | | Collaboration revenue | $8,513 | $20,008 | $12,640 | $31,167 | | Research and development | $22,507 | $28,320 | $47,649 | $59,759 | | General and administrative | $6,993 | $8,551 | $13,798 | $17,303 | | Loss from operations | $(20,987) | $(16,863) | $(48,807) | $(45,895) | | Net loss | $(19,908) | $(10,739) | $(44,947) | $(35,887) | | Net loss per share | $(0.54) | $(0.29) | $(1.21) | $(1.24) | [Condensed Statements of Redeemable Convertible Preferred Stock and Stockholders' Equity](index=8&type=section&id=Condensed%20Statements%20of%20Redeemable%20Convertible%20Preferred%20Stock%20and%20Stockholders'%20Equity) Outlines changes in Metagenomi's equity structure, including the accumulated deficit and the conversion of preferred stock post-IPO - The company's accumulated deficit increased from **$223.0 million** at the end of 2024 to **$267.9 million** as of June 30, 2025, primarily driven by the net loss incurred during the period[28](index=28&type=chunk) - Following the company's IPO in February 2024, all outstanding redeemable convertible preferred stock was converted into **23,935,594 shares of common stock**[28](index=28&type=chunk)[85](index=85&type=chunk) [Condensed Statements of Cash Flows](index=9&type=section&id=Condensed%20Statements%20of%20Cash%20Flows) Summarizes Metagenomi's cash inflows and outflows from operating, investing, and financing activities for the six months ended June 30, 2025 and 2024 Cash Flow Summary for the Six Months Ended June 30 (in thousands) | Cash Flow Activity | 2025 | 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | $(44,093) | $(56,159) | | Net cash provided by (used in) investing activities | $43,800 | $(107,768) | | Net cash provided by (used in) financing activities | $(243) | $84,505 | | **Net (decrease) in cash, cash equivalents and restricted cash** | **$(536)** | **$(79,422)** | - Financing activities in the first six months of 2024 were primarily driven by **$84.5 million** in net proceeds from the company's Initial Public Offering (IPO)[30](index=30&type=chunk) [Notes to Unaudited Condensed Financial Statements](index=10&type=section&id=Notes%20to%20Unaudited%20Condensed%20Financial%20Statements) Provides detailed explanations of Metagenomi's accounting policies, significant agreements, and other financial disclosures supporting the condensed statements - The company had an accumulated deficit of **$267.9 million** as of June 30, 2025. Management believes its existing cash, cash equivalents, and marketable securities of **$205.0 million** are sufficient to fund operations for at least the next 12 months[37](index=37&type=chunk) - The collaboration agreement with Moderna was mutually terminated on April 26, 2024, with the company regaining full rights to its base editing and RNA-mediated integration systems that were subject to the agreement[59](index=59&type=chunk) - A securities class action lawsuit was filed against the company in September 2024, alleging misleading statements regarding the Moderna collaboration. The company has filed a motion to dismiss the claims[82](index=82&type=chunk) - In March 2025, the company established an At-The-Market (ATM) offering program to sell up to **$75.0 million** of its common stock. As of June 30, 2025, no shares have been sold under this program[88](index=88&type=chunk)[89](index=89&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=27&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses Metagenomi's financial condition, operational results, and strategic focus on genome editing therapies and collaborations [Overview](index=27&type=section&id=Overview) Introduces Metagenomi's core business as a precision gene editing company, highlighting its lead program MGX-001 and key collaborations - The company is a precision gene editing company developing curative therapeutics using a proprietary, metagenomics-derived genome editing toolbox[99](index=99&type=chunk) - The lead wholly-owned program, MGX-001 for hemophilia A, is designed to insert a Factor VIII DNA cassette into a 'safe harbor location' of the albumin gene. Emerging data from NHP studies showed higher than expected FVIII activity, prompting additional studies. IND and CTA submissions are planned for 2026[102](index=102&type=chunk)[106](index=106&type=chunk) - The collaboration with Ionis focuses on cardiometabolic diseases, with all four Wave 1 targets achieving in vivo rodent proof-of-concept in 2024. The company plans to nominate one to two development candidates in 2025[108](index=108&type=chunk) - On April 14, 2025, collaboration partner Affini-T exercised an option for a non-exclusive license for one of its pre-specified targets, triggering a **$0.3 million** payment to Metagenomi[109](index=109&type=chunk) [Results of Operations](index=35&type=section&id=Results%20of%20Operations) Analyzes Metagenomi's financial performance, focusing on changes in collaboration revenue, operating expenses, and net loss for the first half of 2025 Comparison of Results for the Six Months Ended June 30 (in thousands) | Metric | 2025 | 2024 | Change ($) | | :--- | :--- | :--- | :--- | | Collaboration revenue | $12,640 | $31,167 | $(18,527) | | Research and development | $47,649 | $59,759 | $(12,110) | | General and administrative | $13,798 | $17,303 | $(3,505) | | Net loss | $(44,947) | $(35,887) | $(9,060) | - The decrease in collaboration revenue for the first six months of 2025 was primarily due to an **$18.7 million** reduction in revenue from the Moderna agreement, which was terminated in April 2024[134](index=134&type=chunk) - Research and development expenses decreased by **$12.1 million** in the first half of 2025 compared to the same period in 2024, driven by reductions in R&D supplies, stock-based compensation, and employee-related costs[136](index=136&type=chunk) [Liquidity and Capital Resources](index=36&type=section&id=Liquidity%20and%20Capital%20Resources) Assesses Metagenomi's financial resources, including cash position and management's outlook on funding future operations - As of June 30, 2025, the company had **$205.0 million** in cash, cash equivalents, and available-for-sale marketable securities[145](index=145&type=chunk) - Management estimates that existing cash will be sufficient to fund projected operating expenses and capital expenditure requirements for at least the next 12 months[145](index=145&type=chunk) - Net cash used in operating activities decreased to **$44.1 million** for the first six months of 2025 from **$56.2 million** in the same period of 2024[147](index=147&type=chunk)[148](index=148&type=chunk)[150](index=150&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=41&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company, as a smaller reporting company, is not required to provide the information for this item - Metagenomi is a smaller reporting company as defined by Rule 12b-2 of the Exchange Act and is therefore not required to provide the information under this item[158](index=158&type=chunk) [Controls and Procedures](index=41&type=section&id=Item%204.%20Controls%20and%20Procedures) Management, including the CEO and CFO, evaluated the company's disclosure controls and procedures and concluded they were effective at a reasonable assurance level as of June 30, 2025. No material changes were made to the company's internal control over financial reporting during the quarter - The company's management, including the principal executive officer and principal financial officer, concluded that disclosure controls and procedures were effective as of June 30, 2025[159](index=159&type=chunk) - There were no changes in internal control over financial reporting during the quarter ended June 30, 2025, that have materially affected, or are reasonably likely to materially affect, internal controls[160](index=160&type=chunk) [PART II. OTHER INFORMATION](index=42&type=section&id=PART%20II.%20OTHER%20INFORMATION) Contains additional disclosures not included in the financial statements, covering legal, risk, equity, and other corporate matters [Legal Proceedings](index=42&type=section&id=Item%201.%20Legal%20Proceedings) The company is subject to a securities class action lawsuit filed in September 2024, as detailed in Note 8 of the financial statements. The company believes the final outcome of ordinary course legal matters will not have a material adverse effect on its business - The company refers to Note 8 of its financial statements for information regarding a securities class action lawsuit filed in September 2024[82](index=82&type=chunk)[162](index=162&type=chunk) [Risk Factors](index=42&type=section&id=Item%201A.%20Risk%20Factors) Details significant risks to Metagenomi's business, including financial position, early-stage development, competition, regulatory challenges, and intellectual property [Risks Related to Financial Position and Need for Capital](index=44&type=section&id=Risks%20Related%20to%20Financial%20Position%20and%20Need%20for%20Capital) Highlights Metagenomi's history of losses, accumulated deficit, and ongoing need for substantial additional funding to support operations - The company has incurred significant losses since inception, with a net loss of **$44.9 million** for the six months ended June 30, 2025, and an accumulated deficit of **$267.9 million**. Profitability is not expected in the foreseeable future[167](index=167&type=chunk) - Substantial additional funding is required for operations. Failure to raise capital on acceptable terms could force the company to delay, reduce, or terminate research and development programs[177](index=177&type=chunk) [Risks Related to Business, Technology, and Industry](index=50&type=section&id=Risks%20Related%20to%20Business,%20Technology,%20and%20Industry) Addresses risks associated with Metagenomi's early-stage development, novel genome editing technology, and intense competition in the biotech industry - The company is in a very early stage of development, with all programs in the research or lead optimization phase. It will be many years, if ever, before a product is commercialized[188](index=188&type=chunk) - The novel nature of genome editing technology subjects the company to risks such as uncertain regulatory guidance, potential for unintended editing events, and immunological reactions[192](index=192&type=chunk)[193](index=193&type=chunk) - The company faces significant competition from major pharmaceutical companies, specialty biotech firms, and academic institutions in the rapidly evolving genome editing field[221](index=221&type=chunk) [Risks Related to Regulatory, Legal, and Clinical Trials](index=68&type=section&id=Risks%20Related%20to%20Regulatory,%20Legal,%20and%20Clinical%20Trials) Covers challenges related to the lengthy and uncertain regulatory approval process, data privacy laws, and potential cybersecurity incidents - The regulatory approval process for novel genome editing product candidates is lengthy, expensive, and uncertain, with a high failure rate in clinical trials[195](index=195&type=chunk) - The company is subject to stringent and evolving data privacy and security laws (e.g., GDPR, CCPA), and failure to comply could result in significant penalties and reputational harm[305](index=305&type=chunk) - Cybersecurity incidents or data breaches could disrupt product development, compromise confidential information, and expose the company to liability[296](index=296&type=chunk) [Risks Related to Third Party Relationships](index=85&type=section&id=Risks%20Related%20to%20Third%20Party%20Relationships) Discusses risks arising from Metagenomi's reliance on collaborations and third-party contract manufacturing organizations for development and supply - The company relies on collaborations with third parties like Ionis and Affini-T and has limited control over the resources they dedicate, which could adversely affect development and commercialization[320](index=320&type=chunk) - Reliance on third-party contract manufacturing organizations (CMOs) for materials and future products increases risks related to supply sufficiency, cost, quality, and regulatory compliance[337](index=337&type=chunk) [Risks Related to Personnel, Operations, and Growth](index=94&type=section&id=Risks%20Related%20to%20Personnel,%20Operations,%20and%20Growth) Focuses on the critical importance of retaining key personnel and the challenges associated with managing future operational expansion - Future success is highly dependent on the ability to retain the CEO and other key executives and to attract and motivate qualified scientific and clinical personnel in a competitive market[350](index=350&type=chunk) - The company expects to expand its operations and may encounter difficulties in managing growth, which could disrupt operations and strain resources[352](index=352&type=chunk) [Risks Related to Our Intellectual Property](index=96&type=section&id=Risks%20Related%20to%20Our%20Intellectual%20Property) Addresses the complexities and uncertainties in obtaining, maintaining, and enforcing intellectual property rights in the competitive CRISPR field - Commercial success depends on the ability to obtain, maintain, and enforce intellectual property rights for its proprietary genome editing systems, which is uncertain and complex[357](index=357&type=chunk)[358](index=358&type=chunk) - The company may be sued for infringing on the intellectual property rights of third parties, which could be costly and prevent or delay the development and commercialization of its products[404](index=404&type=chunk) - The CRISPR technology field is subject to extensive patent filings and complex litigation, creating a risk of infringement claims and challenges to the company's own patents[407](index=407&type=chunk)[408](index=408&type=chunk) [Risks Related to our Common Stock, and Operating as a Public Company](index=114&type=section&id=Risks%20Related%20to%20our%20Common%20Stock,%20and%20Operating%20as%20a%20Public%20Company) Examines risks concerning stock price volatility, ongoing litigation, and reduced disclosure requirements as an emerging growth company - The market price of the company's common stock has been and may continue to be volatile, which could result in substantial losses for investors[428](index=428&type=chunk) - The company is currently subject to a securities class action lawsuit, which is expensive and could divert management's attention and result in substantial damages[430](index=430&type=chunk)[431](index=431&type=chunk) - As an "emerging growth company" and "smaller reporting company," Metagenomi is subject to reduced disclosure requirements, which may make its common stock less attractive to some investors[441](index=441&type=chunk)[442](index=442&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=123&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company reported no unregistered sales of equity securities during the reporting period - None reported[462](index=462&type=chunk) [Defaults Upon Senior Securities](index=123&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) The company reported no defaults upon senior securities - None reported[463](index=463&type=chunk) [Mine Safety Disclosures](index=123&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company - Not applicable[464](index=464&type=chunk) [Other Information](index=123&type=section&id=Item%205.%20Other%20Information) Discloses the recent appointment of Laurence Reid, Ph.D., to Metagenomi's Board of Directors, including his role and compensation - On August 11, 2025, Laurence Reid, Ph.D., was appointed to the Board of Directors and will serve as a member of the Research and Development Committee[465](index=465&type=chunk) - In connection with his appointment, Dr. Reid will be granted a non-statutory stock option to purchase **42,000 shares of common stock**, vesting over a three-year period[468](index=468&type=chunk) [Exhibits](index=125&type=section&id=Item%206.%20Exhibits) Lists all documents filed as exhibits with the Form 10-Q, including corporate governance documents and officer certifications - The report includes key corporate documents and officer certifications as exhibits, such as the Amended and Restated Certificate of Incorporation and Bylaws, and Sarbanes-Oxley Act certifications[471](index=471&type=chunk)

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q ______________________________________ (Mark One) x QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2025 OR o TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-40631 ______________________________________ Caribou Biosciences, Inc. (E ...

Exhibit 99.4 Vinci Compass Investments Ltd. (formerly known as "Vinci Partners Investments Ltd.") Unaudited Interim Condensed Consolidated Financial Statements as of June 30, 2025 Vinci Compass Investments Ltd. Consolidated balance sheets All amounts in thousands of reais unless otherwise stated | Assets | Note | 06/30/2025 | 12/31/2024 | | --- | --- | --- | --- | | Current assets | | | | | Cash and cash equivalents | 5(c) | 189,190 | 223,302 | | Cash and bank deposits | 5(c) | 100,449 | 99,156 | | Financia ...

PART I. FINANCIAL INFORMATION [Item 1. Financial Statements](index=3&type=section&id=Item%201.%20Financial%20Statements) The unaudited condensed consolidated financial statements for Editas Medicine, Inc. as of June 30, 2025, reflect significant asset and equity declines due to operating losses and $66.9 million in restructuring charges [Condensed Consolidated Balance Sheets](index=3&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) Balance Sheet Summary (in thousands) | Metric | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | **Total Current Assets** | $182,796 | $289,315 | | **Total Assets** | $210,581 | $341,589 | | **Total Current Liabilities** | $65,937 | $77,225 | | **Total Liabilities** | $191,392 | $207,315 | | **Total Stockholders' Equity** | $19,189 | $134,274 | - Total assets decreased significantly from **$341.6 million** at the end of 2024 to **$210.6 million** as of June 30, 2025. This was driven by a reduction in marketable securities, accounts receivable, and property and equipment[9](index=9&type=chunk) - Total stockholders' equity saw a sharp decline from **$134.3 million** to **$19.2 million** over the six-month period, largely due to the accumulated deficit increasing from **$1.47 billion** to **$1.60 billion**[9](index=9&type=chunk) [Condensed Consolidated Statements of Operations](index=4&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) Statement of Operations Summary (in thousands, except per share data) | Metric | Q2 2025 | Q2 2024 | H1 2025 | H1 2024 | | :--- | :--- | :--- | :--- | :--- | | Revenues | $3,578 | $513 | $8,236 | $1,649 | | Research and development | $16,181 | $54,210 | $42,774 | $102,997 | | General and administrative | $12,859 | $18,206 | $26,234 | $37,545 | | Restructuring and impairment charges | $26,082 | $— | $66,935 | $— | | **Operating Loss** | **($51,544)** | **($71,903)** | **($127,707)** | **($138,893)** | | **Net Loss** | **($53,235)** | **($67,607)** | **($129,323)** | **($129,557)** | | Net loss per share | ($0.63) | ($0.82) | ($1.54) | ($1.58) | - The company incurred significant restructuring and impairment charges of **$26.1 million** in Q2 2025 and **$66.9 million** in H1 2025, which were not present in the prior year[11](index=11&type=chunk) - Research and development expenses decreased substantially to **$42.8 million** for the six months ended June 30, 2025, from **$103.0 million** in the same period of 2024, reflecting a strategic shift and cost-cutting measures[11](index=11&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Cash Flow Summary for Six Months Ended June 30 (in thousands) | Cash Flow Activity | 2025 | 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | ($98,011) | ($106,934) | | Net cash provided by investing activities | $99,037 | $47,209 | | Net cash provided by financing activities | $5,975 | $514 | | **Net increase (decrease) in cash** | **$7,001** | **($59,211)** | - Cash used in operating activities for the first six months of 2025 was **$98.0 million**, a decrease from **$106.9 million** in the prior year period, despite a similar net loss, due to changes in working capital and non-cash charges like impairment[19](index=19&type=chunk) - Financing activities provided **$6.0 million** in cash, primarily from an at-the-market equity offering which generated **$8.6 million** in proceeds[19](index=19&type=chunk) [Notes to Condensed Consolidated Financial Statements](index=9&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) - The company expects its existing cash, cash equivalents, and marketable securities of **$178.5 million** (as of June 30, 2025) will be sufficient to fund operations for at least twelve months from the issuance date of the financial statements[25](index=25&type=chunk)[27](index=27&type=chunk) - In December 2024, the company discontinued the clinical development of its reni-cel program, leading to a workforce reduction of approximately **180 positions (65%)**. This resulted in total restructuring and impairment charges of **$79.2 million** since the plan's inception[59](index=59&type=chunk)[60](index=60&type=chunk) Restructuring and Impairment Charges Incurred (in thousands) | Charge Type | Q2 2025 | H1 2025 | | :--- | :--- | :--- | | Employee termination benefits | $813 | $4,322 | | Contract costs | $23,466 | $52,341 | | Accelerated expense/lease termination | $1,803 | $6,548 | | Impairment charges | $— | $3,724 | | **Total** | **$26,082** | **$66,935** | - The company sold future revenues from its Vertex License Agreement to DRI Healthcare for an upfront payment of **$57.0 million** in October 2024. This transaction is accounted for as debt with an estimated effective interest rate of **15.1%**[54](index=54&type=chunk)[55](index=55&type=chunk)[56](index=56&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=21&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the strategic pivot to in vivo gene editing, the financial impact of reni-cel discontinuation, and the company's liquidity position expected to fund operations into Q2 2027 [Overview](index=21&type=section&id=Overview) - The company is now focused on developing in vivo gene editing medicines using functional upregulation, aiming to increase the expression of normal genes to treat diseases[77](index=77&type=chunk) - In December 2024, Editas discontinued the commercialization of its reni-cel program for sickle cell disease to optimize its cost structure and accelerate its pivot to in vivo gene editing medicines[78](index=78&type=chunk) - Key strategic goals include selecting a lead development candidate by September 2025, submitting an investigational new drug (IND) application by mid-2026, and achieving human proof-of-concept by year-end 2026[77](index=77&type=chunk) [Results of Operations](index=26&type=section&id=Results%20of%20Operations) Comparison of Three Months Ended June 30, 2025 and 2024 (in thousands) | Metric | Q2 2025 | Q2 2024 | Change ($) | Change (%) | | :--- | :--- | :--- | :--- | :--- | | Revenues | $3,578 | $513 | $3,065 | n/m | | R&D Expenses | $16,181 | $54,210 | ($38,029) | (70)% | | G&A Expenses | $12,859 | $18,206 | ($5,347) | (29)% | | Restructuring Charges | $26,082 | $— | $26,082 | 100% | | **Net Loss** | **($53,235)** | **($67,607)** | **$14,372** | **(21)%** | - The **$38.0 million** decrease in Q2 2025 R&D expenses was primarily driven by a **$24.4 million** reduction in external costs related to the discontinued reni-cel program and a **$5.6 million** decrease in employee-related expenses from the workforce reduction[102](index=102&type=chunk)[104](index=104&type=chunk) Comparison of Six Months Ended June 30, 2025 and 2024 (in thousands) | Metric | H1 2025 | H1 2024 | Change ($) | Change (%) | | :--- | :--- | :--- | :--- | :--- | | Revenues | $8,236 | $1,649 | $6,587 | n/m | | R&D Expenses | $42,774 | $102,997 | ($60,223) | (58)% | | G&A Expenses | $26,234 | $37,545 | ($11,311) | (30)% | | Restructuring Charges | $66,935 | $— | $66,935 | 100% | | **Net Loss** | **($129,323)** | **($129,557)** | **$234** | **—%** | - For the first half of 2025, R&D expenses fell by **$60.2 million** compared to H1 2024, mainly due to a **$34.5 million** decrease in external reni-cel program costs and an **$8.0 million** reduction in employee expenses[111](index=111&type=chunk)[113](index=113&type=chunk) [Liquidity and Capital Resources](index=31&type=section&id=Liquidity%20and%20Capital%20Resources) - As of June 30, 2025, the company had **$178.5 million** in cash, cash equivalents, and marketable securities[117](index=117&type=chunk) - Management expects that existing cash, combined with payments from the Vertex license agreement, will fund operating expenses and capital requirements into the second quarter of 2027[131](index=131&type=chunk) - The company has an At-The-Market (ATM) facility with TD Cowen, with **$141.4 million** remaining available for issuance as of June 30, 2025[118](index=118&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=34&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company's primary market risk is interest rate sensitivity related to its **$178.5 million** in cash, cash equivalents, and marketable securities, with no material foreign currency exposure - The company's primary market risk exposure is to interest rate changes affecting its **$178.5 million** in cash and investments[140](index=140&type=chunk) - Due to the short-term maturities and low-risk profile of its investments (primarily money market funds and U.S. government securities), a **1%** change in interest rates is not expected to have a material impact on their fair market value[140](index=140&type=chunk) - The company does not have any material exposure to foreign currency exchange rate risk as liabilities are substantially denominated in U.S. dollars[141](index=141&type=chunk) [Controls and Procedures](index=35&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that the company's disclosure controls and procedures were effective as of June 30, 2025, with no material changes to internal control over financial reporting during the quarter - As of June 30, 2025, the Chief Executive Officer and Chief Financial Officer concluded that the company's disclosure controls and procedures were effective at the reasonable assurance level[142](index=142&type=chunk) - No changes occurred during the quarter that have materially affected, or are reasonably likely to materially affect, the company's internal control over financial reporting[143](index=143&type=chunk) PART II. OTHER INFORMATION [Legal Proceedings](index=36&type=section&id=Item%201.%20Legal%20Proceedings) The company may face litigation in the ordinary course of business, and its intellectual property rights are subject to ongoing priority and validity disputes - The company may become involved in litigation from the ordinary course of business[146](index=146&type=chunk) - Certain intellectual property rights are subject to priority and validity disputes, which could have a material adverse effect on the business[146](index=146&type=chunk) [Risk Factors](index=36&type=section&id=Item%201A.%20Risk%20Factors) This section details significant risks from ongoing intellectual property disputes concerning CRISPR/Cas9 patents in the U.S. and Europe, where unfavorable outcomes could lead to loss of valuable IP rights - The company's in-licensed patents for CRISPR/Cas9 technology are subject to significant priority and validity disputes in the U.S. and Europe[148](index=148&type=chunk) - A second interference proceeding between the Broad Institute (Editas's licensor) and CVC (University of California) is ongoing. A May 2025 court decision affirmed-in-part and vacated-in-part a prior ruling, remanding the case back to the Patent Trial and Appeal Board (PTAB) for further review[151](index=151&type=chunk) - Additional interference proceedings involving ToolGen, Inc. and Sigma-Aldrich have been declared and are currently suspended pending the outcome of the Broad and CVC appeal[153](index=153&type=chunk)[154](index=154&type=chunk) - In Europe, certain in-licensed patents from Broad have been revoked by the European Patent Office Opposition Division, with appeals pending. Unfavorable outcomes could materially harm the company's business[158](index=158&type=chunk)[159](index=159&type=chunk) [Other Information](index=38&type=section&id=Item%205.%20Other%20Information) This section discloses that no directors or officers adopted or terminated Rule 10b5-1 or non-Rule 10b5-1 trading arrangements during the quarter - No directors or officers adopted or terminated a Rule 10b5-1 trading arrangement or a non-Rule 10b5-1 trading arrangement during the quarterly period[163](index=163&type=chunk) [Exhibits](index=39&type=section&id=Item%206.%20Exhibits) This section lists the exhibits filed with the Quarterly Report on Form 10-Q, including required certifications and financial data in Inline XBRL format - Lists the exhibits filed with the Form 10-Q, including the CEO and CFO certifications (Rule 13a-14(a)) and XBRL data files[165](index=165&type=chunk)

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2025 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to . Commission File Number: 001-42490 MAZE THERAPEUTICS, INC. (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorpora ...

Efficient execution accelerated clinical entry of pan-RAS molecular glue ERAS-0015 and pan-KRAS inhibitor ERAS-4001 Phase 1 monotherapy data for RAS-targeting franchise expected in 2026 Robust balance sheet with cash, cash equivalents, and marketable securities of $387 million as of June 30, 2025 is expected to fund operations into H2 2028 SAN DIEGO, August 12, 2025 (GLOBE NEWSWIRE) -- Erasca, Inc. (Nasdaq: ERAS), a clinical-stage precision oncology company singularly focused on discovering, developing, and ...

PART I – FINANCIAL INFORMATION [ITEM 1. FINANCIAL STATEMENTS](index=4&type=section&id=ITEM%201.%20FINANCIAL%20STATEMENTS) This section presents Anavex Life Sciences Corp.'s unaudited condensed consolidated interim financial statements for the period ended June 30, 2025, including balance sheets, statements of operations and comprehensive loss, cash flows, and changes in stockholders' equity, along with detailed notes explaining business operations, accounting policies, accrued liabilities, other income, equity offerings, commitments, contingencies, and subsequent events [Condensed Consolidated Interim Balance Sheets](index=5&type=section&id=Condensed%20Consolidated%20Interim%20Balance%20Sheets) **Condensed Consolidated Interim Balance Sheet Highlights (in thousands):** | Metric | June 30, 2025 | September 30, 2024 | | :-------------------------------- | :------------ | :----------------- | | Cash and cash equivalents | $101,164 | $132,187 | | Total Assets | $102,432 | $135,567 | | Total Liabilities | $11,474 | $15,304 | | Total Stockholders' Equity | $90,958 | $120,263 | [Condensed Consolidated Interim Statements of Operations and Comprehensive Loss](index=6&type=section&id=Condensed%20Consolidated%20Interim%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) **Condensed Consolidated Interim Statements of Operations and Comprehensive Loss (in thousands, except per share amounts):** | Metric | Three months ended June 30, 2025 | Three months ended June 30, 2024 | Nine months ended June 30, 2025 | Nine months ended June 30, 2024 | | :---------------------------------- | :------------------------------- | :------------------------------- | :------------------------------ | :------------------------------ | | Total operating expenses | $14,459 | $14,603 | $40,564 | $38,606 | | Operating loss | $(14,459) | $(14,603) | $(40,564) | $(38,606) | | Total other income, net | $1,216 | $2,389 | $4,014 | $7,224 | | Net loss and comprehensive loss | $(13,243) | $(12,214) | $(36,550) | $(31,382) | | Net Loss per share (Basic and diluted) | $(0.16) | $(0.14) | $(0.43) | $(0.38) | | Weighted average shares outstanding | 85,380,587 | 84,535,328 | 85,085,795 | 83,022,330 | [Condensed Consolidated Interim Statements of Cash Flows](index=7&type=section&id=Condensed%20Consolidated%20Interim%20Statements%20of%20Cash%20Flows) **Condensed Consolidated Interim Statements of Cash Flows (in thousands):** | Metric | Nine months ended June 30, 2025 | Nine months ended June 30, 2024 | | :-------------------------------------- | :------------------------------ | :------------------------------ | | Net cash used in operating activities | $(30,440) | $(24,154) | | Net cash (used in) provided by financing activities | $(583) | $11,886 | | Decrease in cash and cash equivalents | $(31,023) | $(12,268) | | Cash and cash equivalents, end of period | $101,164 | $138,756 | [Condensed Consolidated Interim Statements of Changes in Stockholders' Equity](index=8&type=section&id=Condensed%20Consolidated%20Interim%20Statements%20of%20Changes%20in%20Stockholders'%20Equity) **Changes in Stockholders' Equity (in thousands, except share amounts):** | Metric | June 30, 2025 | October 1, 2024 | | :------------------------------------ | :------------ | :-------------- | | Common Stock Shares | 85,411,692 | 84,795,517 | | Additional Paid-in Capital | $463,494 | $456,249 | | Accumulated Deficit | $(372,621) | $(336,071) | | Total Stockholders' Equity | $90,958 | $120,263 | - During the nine months ended June 30, 2025, the company issued **360,021 shares** from stock option exercises and **550,000 shares** from cashless exercises, while withholding **293,846 shares** for taxes and cashless exercises. Share-based compensation recognized was **$7,828 thousand**[20](index=20&type=chunk) [Notes to the Condensed Consolidated Interim Financial Statements](index=10&type=section&id=Notes%20to%20the%20Condensed%20Consolidated%20Interim%20Financial%20Statements) [Note 1 Business Description](index=10&type=section&id=Note%201%20Business%20Description) - Anavex Life Sciences Corp. is a clinical-stage biopharmaceutical company focused on developing precision medicine therapeutics for central nervous system (CNS) diseases with high unmet needs, including Alzheimer's, Parkinson's, schizophrenia, neurodevelopmental, neurodegenerative, and rare diseases like Rett syndrome[21](index=21&type=chunk)[22](index=22&type=chunk) [Note 2 Basis of Presentation](index=10&type=section&id=Note%202%20Basis%20of%20Presentation) - The unaudited condensed consolidated interim financial statements are prepared in accordance with SEC rules and U.S. GAAP for interim reporting, with certain disclosures condensed or omitted. Management believes current working capital is sufficient for over 12 months, but future financing may be needed for costly drug development[23](index=23&type=chunk)[28](index=28&type=chunk)[29](index=29&type=chunk) - The Company has not generated any revenue from operations to date and expects negative cash flows for the foreseeable future[27](index=27&type=chunk) - As of June 30, 2025, **15,463,566** potentially dilutive common shares related to outstanding options and warrants were excluded from diluted loss per share calculation due to their anti-dilutive effect[35](index=35&type=chunk) [Note 3 Accrued Liabilities](index=12&type=section&id=Note%203%20Accrued%20Liabilities) **Principal Components of Accrued Liabilities (in thousands):** | Component | June 30, 2025 | September 30, 2024 | | :----------------------------- | :------------ | :----------------- | | Accrued investigator payments | $149 | $860 | | Accrued compensation and benefits | $1,188 | $1,527 | | Milestone-based contract accruals | $547 | $557 | | All other accrued liabilities | $2,045 | $1,891 | | **Total accrued liabilities** | **$3,929** | **$4,835** | [Note 4 Other Income](index=12&type=section&id=Note%204%20Other%20Income) - The Company recognized **$25 thousand** and **$37 thousand** in grant income for the three and nine months ended June 30, 2025, respectively, from a **$1.0 million** Michael J. Fox Foundation research grant for ANAVEX2-73 in Parkinson's disease. **$0.8 million** remains as deferred grant income[39](index=39&type=chunk)[40](index=40&type=chunk) **Research and Development Incentive Income (in millions):** | Period | 2025 (USD) | 2025 (AUD) | 2024 (USD) | 2024 (AUD) | | :----------------------------- | :--------- | :--------- | :--------- | :--------- | | Three months ended June 30, | $0.1 | $0.2 | $0.5 | $0.8 | | Nine months ended June 30, | $0.6 | $1.0 | $1.6 | $2.4 | - Research and development incentive income, primarily from the Australia R&D credit, decreased for both the three and nine months ended June 30, 2025, compared to 2024. The Company's tax incentive claims from 2020 to 2024 are open to potential review by the ATO[42](index=42&type=chunk)[46](index=46&type=chunk) [Note 5 Equity Offerings](index=13&type=section&id=Note%205%20Equity%20Offerings) - The Company has a **$150.0 million** purchase agreement with Lincoln Park Capital Fund, LLC (2023 Purchase Agreement) valid until February 3, 2026. As of June 30, 2025, **$110.8 million** remains unused, and a prospectus supplement is required to access these funds[49](index=49&type=chunk)[51](index=51&type=chunk) - No shares were issued under the 2023 Purchase Agreement during the nine months ended June 30, 2025, compared to **2,455,646 shares** for **$11.3 million** in the comparable 2024 period[51](index=51&type=chunk) - The 2020 Sales Agreement with Cantor Fitzgerald & Co. and SVB Leerink LLC was terminated on July 24, 2024, with no shares sold during the nine months ended June 30, 2024[52](index=52&type=chunk)[53](index=53&type=chunk)[54](index=54&type=chunk) - During the nine months ended June 30, 2025, the Company issued **217,503 common shares** to its CEO and **38,651 shares** to a director upon net exercise of stock options, involving withholding shares for exercise price and tax obligations[55](index=55&type=chunk)[56](index=56&type=chunk) [Note 6 Commitments and Contingencies](index=15&type=section&id=Note%206%20Commitments%20and%20Contingencies) **Operating Lease Costs (in thousands):** | Period | Three months ended June 30, 2025 | Three months ended June 30, 2024 | Nine months ended June 30, 2025 | Nine months ended June 30, 2024 | | :-------------------- | :------------------------------- | :------------------------------- | :------------------------------ | :------------------------------ | | Operating lease costs | $33 | $31 | $99 | $92 | **401(k) Plan Contributions (in thousands):** | Period | Three months ended June 30, 2025 | Three months ended June 30, 2024 | Nine months ended June 30, 2025 | Nine months ended June 30, 2024 | | :-------------------------- | :------------------------------- | :------------------------------- | :------------------------------ | :------------------------------ | | Contributions to 401(k) plan | $56 | $98 | $213 | $223 | - A shareholder class action lawsuit filed on March 13, 2024, alleging violations related to ANAVEX2-73 Rett syndrome clinical trials, was dismissed on June 18, 2025, but the plaintiff filed an appeal. Two similar derivative lawsuits have been stayed pending the outcome of the class action[61](index=61&type=chunk)[63](index=63&type=chunk)[64](index=64&type=chunk) **Stock Option Activity (Nine months ended June 30, 2025):** | Metric | Number of Options | Weighted Average Exercise Price ($) | Weighted Average Grant Date Fair Value ($) | | :-------------------------- | :---------------- | :-------------------------------- | :--------------------------------------- | | Outstanding, Sept 30, 2024 | 15,037,754 | 6.80 | 5.12 | | Granted | 1,488,500 | 8.58 | 6.22 | | Expired | (100,000) | 16.24 | — | | Exercised | (910,021) | 2.45 | 1.40 | | Forfeited | (62,667) | 4.79 | 3.59 | | Outstanding, June 30, 2025 | 15,453,566 | 7.17 | 5.41 | | Exercisable, June 30, 2025 | 10,541,530 | 6.07 | 4.73 | **Share-based Compensation Expense (in thousands):** | Expense Category | Three months ended June 30, 2025 | Three months ended June 30, 2024 | Nine months ended June 30, 2025 | Nine months ended June 30, 2024 | | :-------------------------- | :------------------------------- | :------------------------------- | :------------------------------ | :------------------------------ | | General and administrative | $1,717 | $997 | $3,124 | $2,901 | | Research and development | $2,607 | $1,491 | $4,704 | $4,524 | | **Total share-based compensation** | **$4,324** | **$2,488** | **$7,828** | **$7,425** | [Note 7 Subsequent Events](index=19&type=section&id=Note%207%20Subsequent%20Events) - On July 25, 2025, the Company entered into a Sales Agreement with TD Securities (USA) LLC to offer and sell up to **$150 million** in common stock through an 'at the market offering' or negotiated transactions, with commissions up to **3.0%** of gross proceeds[80](index=80&type=chunk)[81](index=81&type=chunk)[82](index=82&type=chunk) - On July 4, 2025, the 'One Big Beautiful Bill Act' was signed into law, which is expected to allow for more taxpayer-favorable treatment of R&D expenditures for US income tax purposes, and the Company is evaluating its financial impact[83](index=83&type=chunk) [ITEM 2. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS.](index=20&type=section&id=ITEM%202.%20MANAGEMENT'S%20DISCUSSION%20AND%20ANALYSIS%20OF%20FINANCIAL%20CONDITION%20AND%20RESULTS%20OF%20OPERATIONS.) This section provides management's perspective on the Company's financial condition and operational results, highlighting its clinical-stage biopharmaceutical focus, pipeline development, and financial performance. It details R&D efforts, clinical trial progress for key drug candidates (ANAVEX2-73, ANAVEX3-71), intellectual property, and financial results including operating expenses, net loss, and liquidity, along with forward-looking statements and risk factors [Forward-Looking Statements](index=20&type=section&id=Forward-Looking%20Statements) - The report contains forward-looking statements regarding future clinical and regulatory milestones, financial position, business strategy, and operations, identified by words like 'believe,' 'may,' 'expect,' and 'will.'[84](index=84&type=chunk) - These statements are based on current expectations and projections but are subject to risks and uncertainties, including stock price volatility, ability to conduct trials, raise capital, generate revenue, and obtain regulatory approvals[85](index=85&type=chunk)[86](index=86&type=chunk) [Overview and Strategy](index=21&type=section&id=Overview%20and%20Strategy) - Anavex Life Sciences Corp. is a clinical-stage biopharmaceutical company developing differentiated therapeutics for CNS diseases using precision medicine and genomic data to identify biomarkers[89](index=89&type=chunk) - The Company focuses on innovative treatments for Alzheimer's, Parkinson's, schizophrenia, neurodevelopmental, neurodegenerative, and rare diseases like Rett syndrome, with a pipeline including ANAVEX2-73 and ANAVEX3-71[90](index=90&type=chunk) - Anavex's compounds target sigma-1 receptor (SIGMAR1), an intracellular chaperone protein crucial for cellular communication and restoring homeostasis, which is believed to be involved in the pathogenesis of many neurodegenerative and neurodevelopmental diseases[91](index=91&type=chunk)[93](index=93&type=chunk)[94](index=94&type=chunk) [Clinical Program Overview](index=23&type=section&id=Clinical%20Program%20Overview) - ANAVEX2-73 (blarcamesine) is being developed as a disease-modifying approach for neurodegenerative and neurodevelopmental diseases through SIGMAR1 activation, available in oral capsule and liquid formulations[96](index=96&type=chunk) [ANAVEX®2-73 (blarcamesine)](index=23&type=section&id=ANAVEX%C2%AE2-73%20(blarcamesine)) [Alzheimer's Disease](index=23&type=section&id=Alzheimer's%20Disease) - ANAVEX2-73's Phase 2b/3 trial in early Alzheimer's disease met co-primary endpoints, showing significant improvements in ADAS-Cog13 (P < **0.025**) and CDR-SB (P < **0.025**) at **48 weeks**, slowing clinical progression by **36.3%** overall[101](index=101&type=chunk)[102](index=102&type=chunk) - The drug also significantly slowed brain atrophy in key regions (whole brain by **37.6%**, total grey matter by **63.5%**, lateral ventricles by **25.1%**) and showed a good safety profile, with dizziness as a common, transient adverse event[102](index=102&type=chunk)[103](index=103&type=chunk) - A Marketing Authorisation Application (MAA) for ANAVEX2-73 for Alzheimer's disease was submitted to and accepted by the European Medicines Agency (EMA) in November/December 2024 for scientific review[104](index=104&type=chunk) [Parkinson's Disease](index=24&type=section&id=Parkinson's%20Disease) - ANAVEX2-73 demonstrated clinically meaningful, dose-dependent, and statistically significant improvements in cognitive (CDR computerized assessment) and motor impairment (MDS-UPDRS total score) in a Phase 2 trial for Parkinson's disease dementia[108](index=108&type=chunk) - Preliminary data from the **48-week** Open Label Extension (OLE) trial showed longitudinal beneficial effects on primary and secondary objectives, with consistent improvement in MDS-UPDRS Part II + III and CGI-I after resuming treatment[110](index=110&type=chunk) - The Company plans further clinical trials for ANAVEX2-73 in Parkinson's disease dementia and received a **$1.0 million** research grant from The Michael J. Fox Foundation to explore PET imaging biomarkers[111](index=111&type=chunk)[112](index=112&type=chunk) [Rett Syndrome](index=25&type=section&id=Rett%20Syndrome) - ANAVEX2-73 has received Orphan Drug, Rare Pediatric Disease, and Fast Track designations from the FDA for Rett syndrome treatment[114](index=114&type=chunk) - The AVATAR Phase 3 trial met all primary and secondary efficacy and safety endpoints, showing statistically significant improvements in RSBQ (p = **0.037**), ADAMS (p = **0.010**), and CGI-I (p = **0.037**) responses[117](index=117&type=chunk) - The EXCELLENCE Phase 2/3 trial in pediatric patients showed improvement on the RSBQ co-primary endpoint, with a statistically significant rapid onset of action at **4 weeks** (p=**0.041**), and no new safety signals[120](index=120&type=chunk)[121](index=121&type=chunk)[123](index=123&type=chunk) [Other indications](index=27&type=section&id=Other%20indications) - Preclinical data supports ANAVEX2-73's potential as a platform drug for other neurodegenerative diseases, including epilepsy, infantile spasms, Fragile X syndrome, Angelman syndrome, multiple sclerosis, and tuberous sclerosis complex (TSC)[125](index=125&type=chunk) - ANAVEX2-73 significantly reduced audiogenic-induced seizures in Angelman syndrome mouse models and restored hippocampal brain-derived neurotrophic factor (BDNF) expression in Fragile X syndrome models[126](index=126&type=chunk) - Preclinical data also suggests ANAVEX2-73 may promote remyelination in multiple sclerosis and provide protection for oligodendrocytes, OPCs, and CNS neurons[128](index=128&type=chunk) [ANAVEX2-73 (blarcamesine)-specific Biomarkers](index=28&type=section&id=ANAVEX2-73%20(blarcamesine)-specific%20Biomarkers) - Genomic analysis of Alzheimer's patients treated with ANAVEX2-73 identified actionable genetic variants, including SIGMAR1 and COMT, which significantly impact drug response[130](index=130&type=chunk) - Excluding patients with the identified SIGMAR1 biomarker variant (**10%-20%** of the population) in prospective studies could lead to **80%-90%** of patients showing clinically significant improved functional and cognitive scores[130](index=130&type=chunk) [ANAVEX3-71](index=28&type=section&id=ANAVEX3-71) - ANAVEX3-71 is an orally available clinical drug candidate with a novel mechanism of action via SIGMAR1 activation and M1 muscarinic allosteric modulation, showing neuroprotection and cognition enhancement in Alzheimer's models[131](index=131&type=chunk) - The Phase 1 clinical trial met primary and secondary endpoints for safety, tolerability, and PK, with no serious adverse events or dose-limiting toxicities, and demonstrated linear, dose-proportional, and time-invariant pharmacokinetics[135](index=135&type=chunk)[137](index=137&type=chunk) - Based on preclinical and Phase 1 results, the Company plans to advance ANAVEX3-71 into a biomarker-driven clinical development program for schizophrenia, Frontotemporal Dementia (FTD), and Alzheimer's disease[138](index=138&type=chunk) [Schizophrenia](index=29&type=section&id=Schizophrenia) - The U.S. FDA-cleared ANAVEX3-71-SZ-001 Phase 2 trial in schizophrenia commenced in March 2024, exploring multiple ascending doses and a **28-day** treatment period, utilizing standard clinical outcome measures and novel fluid/electrophysiological biomarkers[139](index=139&type=chunk) - Preliminary results from Part A showed a dose-dependent effect of ANAVEX3-71 on two key EEG biomarkers, reversing known abnormalities associated with schizophrenia and correlating with positive, negative, and cognitive symptoms[140](index=140&type=chunk) - Enrollment for Part B of the Phase 2 study was completed in May 2025, with top-line data expected in the second half of 2025[141](index=141&type=chunk) [ANAVEX1-41](index=30&type=section&id=ANAVEX1-41) - ANAVEX1-41 is a sigma-1 agonist that demonstrated significant neuroprotective benefits in preclinical tests by modulating endoplasmic reticulum, mitochondrial, and oxidative stress, and preventing caspase-3 expression[142](index=142&type=chunk)[143](index=143&type=chunk) [ANAVEX1066](index=30&type=section&id=ANAVEX1066) - ANAVEX1066, a mixed sigma-1/sigma-2 ligand, is designed for neuropathic and visceral pain treatment, showing rapid, dose-dependent efficacy in preclinical models without affecting normal gastrointestinal transit[144](index=144&type=chunk) [ANAVEX1037](index=30&type=section&id=ANAVEX1037) - ANAVEX1037 is a synthetic compound with high affinity for sigma-1 receptors, designed for prostate and pancreatic cancer treatment, demonstrating antitumor potential by selectively killing cancer cells and suppressing tumor growth in preclinical studies[145](index=145&type=chunk)[146](index=146&type=chunk) [Our Target Indications](index=30&type=section&id=Our%20Target%20Indications) - The Company is developing compounds for Central Nervous System Diseases, including Alzheimer's disease (**7.2 million** Americans aged 65+ in 2025), Parkinson's disease (**10+ million** worldwide), Rett syndrome (**1 in 10,000-15,000 females**), Schizophrenia (**24 million** worldwide), Fragile X (**1.4 million** worldwide), and Depression[148](index=148&type=chunk)[149](index=149&type=chunk) - Target indications also include Epilepsy (**3.4 million** Americans in 2015), Neuropathic Pain, and Cancer, specifically Malignant Melanoma (market expected to reach **$7.5 billion** by 2029), Prostate Cancer (market expected to reach **$10.1 billion** by 2030), and Pancreatic Cancer (market expected to reach **$3.7 billion** by 2027)[150](index=150&type=chunk)[155](index=155&type=chunk) [Patents, Trademarks and Intellectual Property](index=32&type=section&id=Patents,%20Trademarks%20and%20Intellectual%20Property) - Anavex holds ownership or exclusive rights to **30 issued U.S. patents** and **20 pending U.S. patent applications**, along with numerous PCT and ex-U.S. applications, related to its drug candidates and research programs[151](index=151&type=chunk) - Key patents include those for ANAVEX2-73 (composition of matter, crystalline polymorphs, seizure treatment, neurodevelopmental disorders, cardiac dysfunction, insomnia/anxiety/agitation, systolic hypertension), ANAVEX19-144, ANAVEX1-41, ANAVEX1066, and ANAVEX3-71[152](index=152&type=chunk)[153](index=153&type=chunk)[154](index=154&type=chunk)[156](index=156&type=chunk)[157](index=157&type=chunk)[158](index=158&type=chunk)[159](index=159&type=chunk)[160](index=160&type=chunk)[161](index=161&type=chunk)[162](index=162&type=chunk)[163](index=163&type=chunk)[165](index=165&type=chunk) - Most of these patents are expected to expire between **2030** and **2039**, absent any patent term extensions for regulatory delays[152](index=152&type=chunk)[153](index=153&type=chunk)[154](index=154&type=chunk)[156](index=156&type=chunk)[157](index=157&type=chunk)[158](index=158&type=chunk)[159](index=159&type=chunk)[160](index=160&type=chunk)[161](index=161&type=chunk)[162](index=162&type=chunk)[163](index=163&type=chunk)[164](index=164&type=chunk)[165](index=165&type=chunk) [Financial Overview](index=34&type=section&id=Financial%20Overview) - The Company is in the development stage and has not earned any revenue since its inception in 2004, anticipating revenue only upon establishing alliances for product development, licensing, or marketing[170](index=170&type=chunk) [Operating Expenses](index=34&type=section&id=Operating%20Expenses) **Operating Expenses (in thousands):** | Expense Category | Three months ended June 30, 2025 | Three months ended June 30, 2024 | Nine months ended June 30, 2025 | Nine months ended June 30, 2024 | | :-------------------------- | :------------------------------- | :------------------------------- | :------------------------------ | :------------------------------ | | Total operating expenses | $14,459 | $14,603 | $40,564 | $38,606 | | Research and development | $9,959 | $11,811 | $30,298 | $30,224 | | General and administrative | $4,500 | $2,792 | $10,266 | $8,382 | - The decrease in R&D expenses for the three-month period was primarily due to a **$1.9 million** decrease in manufacturing for ANAVEX2-73 and a **$1.0 million** decrease in the Alzheimer's program, partially offset by a **$1.1 million** increase in stock-based compensation[175](index=175&type=chunk)[178](index=178&type=chunk) - G&A expenses increased for both periods, mainly due to higher corporate and intellectual property legal fees, and an increase in non-cash stock-based compensation from new milestone-based options[177](index=177&type=chunk) [Other income (net)](index=36&type=section&id=Other%20income%20(net)) **Net Other Income (in thousands):** | Period | Three months ended June 30, 2025 | Three months ended June 30, 2024 | Nine months ended June 30, 2025 | Nine months ended June 30, 2024 | | :-------------------- | :------------------------------- | :------------------------------- | :------------------------------ | :------------------------------ | | Net other income | $1,216 | $2,389 | $4,014 | $7,224 | - The decrease in net other income for both periods was primarily due to a reduction in research and development incentive income (following the completion of Australian clinical trials) and lower interest income (due to reduced cash balances and market interest rates)[179](index=179&type=chunk) [Net loss](index=36&type=section&id=Net%20loss) **Net Loss and EPS:** | Period | Net Loss (in millions) | EPS | | :------------------------------- | :--------------------- | :---- | | Three months ended June 30, 2025 | $(13.2) | $(0.16) | | Three months ended June 30, 2024 | $(12.2) | $(0.14) | | Nine months ended June 30, 2025 | $(36.6) | $(0.43) | | Nine months ended June 30, 2024 | $(31.4) | $(0.38) | - The increase in net loss for both periods is primarily attributed to the net increases in operating expenses and net decreases in other income[181](index=181&type=chunk) [Liquidity and Capital Resources](index=36&type=section&id=Liquidity%20and%20Capital%20Resources) [Working Capital](index=36&type=section&id=Working%20Capital) **Working Capital (in thousands):** | Metric | June 30, 2025 | September 30, 2024 | | :---------------- | :------------ | :----------------- | | Current Assets | $102,432 | $135,567 | | Current Liabilities | $11,474 | $15,304 | | **Working Capital** | **$90,958** | **$120,263** | - Net current assets decreased by approximately **$29.3 million** from September 30, 2024, to June 30, 2025, primarily due to cash utilized in operations[182](index=182&type=chunk) [Cash Flows](index=36&type=section&id=Cash%20Flows) **Summary of Cash Flows (in thousands):** | Activity | Nine months ended June 30, 2025 | Nine months ended June 30, 2024 | | :-------------------------------------- | :------------------------------ | :------------------------------ | | Net cash used in operating activities | $(30,440) | $(24,154) | | Net cash (used in) provided by financing activities | $(583) | $11,886 | | Decrease in cash and cash equivalents | $(31,023) | $(12,268) | - Net cash used in operating activities increased by **$6.3 million**, from **$24.2 million** in 2024 to **$30.4 million** in 2025, primarily due to an increased net loss and decreased working capital balances[185](index=185&type=chunk) - Cash flows from financing activities shifted from a **$11.9 million** inflow in 2024 (primarily from common share issuance under the 2023 Purchase Agreement) to a **$0.6 million** outflow in 2025 (due to tax withholding for stock option exercises)[186](index=186&type=chunk)[187](index=187&type=chunk)[188](index=188&type=chunk) [Other Financings](index=37&type=section&id=Other%20Financings) - On July 25, 2025, the Company entered into a Sales Agreement with TD Securities (USA) LLC to sell up to **$150 million** in common stock through an 'at the market offering' or negotiated transactions, with commissions up to **3.0%**[189](index=189&type=chunk)[190](index=190&type=chunk)[191](index=191&type=chunk) - The 2023 Purchase Agreement with Lincoln Park Capital Fund, LLC allows the Company to sell up to **$150.0 million** in common stock until February 3, 2026. As of June 30, 2025, **$110.8 million** remains unused, and no shares were issued under this agreement during the nine months ended June 30, 2025[192](index=192&type=chunk)[197](index=197&type=chunk)[198](index=198&type=chunk) [Off-Balance Sheet Arrangements](index=38&type=section&id=Off-Balance%20Sheet%20Arrangements) - The Company has no off-balance sheet arrangements that have or are reasonably likely to have a material current or future effect on its financial condition, revenues, expenses, results of operations, liquidity, or capital resources[199](index=199&type=chunk) [CRITICAL ACCOUNTING POLICIES](index=38&type=section&id=CRITICAL%20ACCOUNTING%20POLICIES) - There have been no significant changes to the Company's critical accounting policies and estimates since its Annual Report on Form 10-K for the year ended September 30, 2024[201](index=201&type=chunk) [RECENT ACCOUNTING PRONOUNCEMENTS](index=38&type=section&id=RECENT%20ACCOUNTING%20PRONOUNCEMENTS) - The Company refers to Note 2, 'Recent Accounting Pronouncements,' in its Condensed Consolidated Interim Financial Statements for details on new FASB ASUs, including ASU No. 2023-07 (Segment Reporting) and ASU No. 2023-09 (Income Taxes), and is currently assessing their impact[36](index=36&type=chunk)[37](index=37&type=chunk)[202](index=202&type=chunk) [ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISKS.](index=38&type=section&id=ITEM%203.%20QUANTITATIVE%20AND%20QUALITATIVE%20DISCLOSURES%20ABOUT%20MARKET%20RISKS.) As a smaller reporting company, Anavex Life Sciences Corp. is not required to provide quantitative and qualitative disclosures about market risks in this quarterly report - The Company is a smaller reporting company and is not required to provide quantitative and qualitative disclosures about market risks[203](index=203&type=chunk) [ITEM 4. CONTROLS AND PROCEDURES](index=38&type=section&id=ITEM%204.%20CONTROLS%20AND%20PROCEDURES) This section confirms the effectiveness of Anavex Life Sciences Corp.'s disclosure controls and procedures as of June 30, 2025, based on management's evaluation, and states that no material changes to internal control over financial reporting occurred during the quarter [Disclosure Controls and Procedures](index=38&type=section&id=Disclosure%20Controls%20and%20Procedures) - As of June 30, 2025, the Company's disclosure controls and procedures were evaluated by management, including the principal executive and financial officers, and concluded to be effective[204](index=204&type=chunk)[205](index=205&type=chunk) [Changes in Internal Control over Financial Reporting](index=39&type=section&id=Changes%20in%20Internal%20Control%20over%20Financial%20Reporting) - No changes to the Company's internal control over financial reporting were identified during the quarter ended June 30, 2025, that materially affected, or are reasonably likely to materially affect, internal controls[206](index=206&type=chunk) PART II – OTHER INFORMATION [ITEM 1. LEGAL PROCEEDINGS](index=39&type=section&id=ITEM%201.%20LEGAL%20PROCEEDINGS) Anavex Life Sciences Corp. is involved in several legal proceedings, including a shareholder class action lawsuit related to ANAVEX2-73 Rett syndrome clinical trials, which was dismissed but is under appeal. Two similar derivative lawsuits have been stayed pending the outcome of the class action. The Company believes no loss is probable and has not recorded any contingencies - A shareholder class action complaint filed on March 13, 2024, alleging violations related to ANAVEX2-73 Rett syndrome clinical trials, was dismissed on June 18, 2025, but the plaintiff filed a notice of appeal on July 17, 2025[208](index=208&type=chunk) - Two derivative lawsuits with similar allegations have been filed against the Company and its officers/directors, both of which have been stayed pending the resolution of the initial class action lawsuit[210](index=210&type=chunk)[211](index=211&type=chunk) - The Company believes it is not probable that any loss will occur from these lawsuits and has not recorded any loss contingencies in the financial statements[208](index=208&type=chunk)[210](index=210&type=chunk)[211](index=211&type=chunk) [ITEM 1A. RISK FACTORS](index=40&type=section&id=ITEM%201A.%20RISK%20FACTORS) This section updates the risk factors, emphasizing the lengthy, complex, and unpredictable nature of pharmaceutical marketing approval processes, particularly with the EMA and FDA. It highlights that approval in one jurisdiction does not guarantee approval in others and that the Company's business could be adversely affected by litigation, government investigations, and changes in U.S. and international trade policies - There have been no material changes to the risk factors discussed in the Annual Report on Form 10-K, except for specific risks related to the marketing approval process and business operations[213](index=213&type=chunk) - The marketing approval process for pharmaceutical products by the EMA, FDA, and other authorities is lengthy, complex, and unpredictable, with no guarantee of approval, and a failure or delay in one jurisdiction can negatively impact others[213](index=213&type=chunk)[215](index=215&type=chunk)[216](index=216&type=chunk) - The Company's business is subject to risks from litigation, government investigations, and enforcement actions, which can be expensive and time-consuming, potentially resulting in fines, penalties, and reputational damage[217](index=217&type=chunk)[218](index=218&type=chunk) - Changes in U.S. and international trade policies, such as tariffs, could adversely impact the Company's business, affecting import/export costs, product demand, and commercial activities[219](index=219&type=chunk) [ITEM 2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS](index=41&type=section&id=ITEM%202.%20UNREGISTERED%20SALES%20OF%20EQUITY%20SECURITIES%20AND%20USE%20OF%20PROCEEDS) Anavex Life Sciences Corp. did not report any unregistered sales of equity securities during the period covered by this Quarterly Report on Form 10-Q that were not previously disclosed - The Company has not sold any equity securities that were not registered under the Securities Act of 1933 and not previously reported in a Current Report on Form 8-K during the period[220](index=220&type=chunk) [ITEM 3. DEFAULTS UPON SENIOR SECURITIES](index=41&type=section&id=ITEM%203.%20DEFAULTS%20UPON%20SENIOR%20SECURITIES) Anavex Life Sciences Corp. reported no defaults upon senior securities during the period - There were no defaults upon senior securities during the reporting period[221](index=221&type=chunk) [ITEM 4. MINE SAFETY DISCLOSURES](index=41&type=section&id=ITEM%204.%20MINE%20SAFETY%20DISCLOSURES) This item is not applicable to Anavex Life Sciences Corp - This item is not applicable to the Company[222](index=222&type=chunk) [ITEM 5. OTHER INFORMATION](index=41&type=section&id=ITEM%205.%20OTHER%20INFORMATION) Anavex Life Sciences Corp. reported no adoption, modification, or termination of Rule 10b5-1 or non-Rule 10b5-1 trading arrangements by its directors or Section 16 officers during the three-month period ended June 30, 2025 - None of the Company's directors or Section 16 officers adopted, modified, or terminated a 'Rule 10b5-1 trading arrangement' or 'non-Rule 10b5-1 trading arrangement' during the three-month period ended June 30, 2025[223](index=223&type=chunk) [ITEM 6. EXHIBITS](index=42&type=section&id=ITEM%206.%20EXHIBITS) This section lists the exhibits filed with the Quarterly Report on Form 10-Q, including articles of incorporation, bylaws, an amendment to the 2022 Omnibus Incentive Plan, Rule 13a-14(a)/15(d)-14(a) certifications, Section 1350 certifications, and XBRL instance documents - The exhibits include Articles of Incorporation, Amended and Restated Bylaws, Amendment No. 1 to the 2022 Omnibus Incentive Plan, Rule 13a-14(a)/15(d)-14(a) Certifications, Section 1350 Certifications, and XBRL documents[224](index=224&type=chunk) SIGNATURES - The report was duly signed on August 12, 2025, by Christopher Missling, PhD, Chief Executive Officer (Principal Executive Officer), and Sandra Boenisch, CPA, CGA, Principal Financial Officer (Principal Financial and Accounting Officer)[227](index=227&type=chunk)[228](index=228&type=chunk)

News Release For Immediate Release: August 12, 2025 H&R Block Reports Fiscal 2025 Results and Provides Fiscal 2026 Outlook - Delivered Revenue Growth of 4% and Earnings per Share Growth of 7% - - Returned $600 Million to Shareholders via Dividends and Share Repurchases - Exhibit 99.1 - Increases Quarterly Dividend by 12% - KANSAS CITY, Mo., August 12, 2025 (GLOBE NEWSWIRE) -- H&R Block, Inc. (NYSE: HRB) (the "Company") today released financial results for its fiscal 2025 year ended June 30, 2025. 1 "Fiscal ...

[Executive Summary](index=1&type=section&id=Executive%20Summary) INOVIO announced Q2 2025 results, with the CEO confirming the INO-3107 BLA submission is on track for 2H25, targeting mid-2026 FDA approval [Introduction and CEO Statement](index=1&type=section&id=Introduction%20and%20CEO%20Statement) INOVIO announced its second quarter 2025 financial results and provided business updates, with the CEO highlighting that the Biologics License Application (BLA) for INO-3107 is on track for submission in the second half of 2025, aiming for FDA acceptance by year-end and potential approval by mid-2026 - INO-3107 BLA submission remains on track for **2H25**, with the goal of FDA acceptance by year-end[3](index=3&type=chunk) - Potential INO-3107 approval date is anticipated in **mid-2026**[3](index=3&type=chunk) [Operational Highlights](index=1&type=section&id=Operational%20Highlights) INOVIO advanced INO-3107 with BLA progress and strong clinical data, while also presenting next-gen DNA medicine data and strengthening its financial position [INO-3107 (Recurrent Respiratory Papillomatosis - RRP)](index=1&type=section&id=INO-3107%20(Recurrent%20Respiratory%20Papillomatosis%20-%20RRP)) INOVIO made significant progress with INO-3107, completing device verification testing and initiating a rolling BLA submission, with long-term clinical data demonstrating sustained efficacy and safety, showing a substantial reduction in surgeries for RRP patients [Regulatory and Commercial Progress](index=1&type=section&id=Regulatory%20and%20Commercial%20Progress) INOVIO completed device verification for CELLECTRA® 5PSP, requested a rolling BLA submission for INO-3107, and advanced commercial preparations - Completed design verification (DV) testing for the CELLECTRA® 5PSP device, a requirement for BLA submission[4](index=4&type=chunk)[5](index=5&type=chunk) - Requested rolling submission from the US FDA for INO-3107 in **July 2025**, leveraging its Breakthrough Therapy designation[4](index=4&type=chunk)[5](index=5&type=chunk) - Continuing to advance commercial preparations for the potential launch of INO-3107 in **2026**, if approved by the FDA[5](index=5&type=chunk) [Clinical Data and Efficacy](index=2&type=section&id=Clinical%20Data%20and%20Efficacy) Long-term clinical data for INO-3107, published in The Laryngoscope, demonstrated sustained efficacy with significant reductions in RRP surgeries and a favorable safety profile - Data from a retrospective study (RRP-002) investigating the long-term clinical efficacy of INO-3107 were published in The Laryngoscope[5](index=5&type=chunk)[6](index=6&type=chunk) - Patients experiencing a **50-100% reduction in surgeries** (Overall Response Rate) increased from **72% at Year 1 to 86% at Year 2**[9](index=9&type=chunk) - Patients achieving a Complete Response (**0 surgeries per year**) increased from **28% for Year 1 to 50% for Year 2**[9](index=9&type=chunk) - Mean number of surgeries reduced from **4.1 (pre-treatment) to 1.7 (Year 1) and further to 0.9 (Year 2)**[9](index=9&type=chunk) - INO-3107 was well tolerated, with no serious adverse events or long-term safety concerns identified[9](index=9&type=chunk) [Next Generation DNA Medicine Candidates](index=2&type=section&id=Next%20Generation%20DNA%20Medicine%20Candidates) INOVIO presented data on its next-generation DNA medicine technology, including DNA-encoded monoclonal antibodies (DMAbs) for COVID-19 and DNA-encoded protein technology (DPROT) for long-term protein expression, at the Orphan Drug Summit - Presented data on next-generation DNA medicine technology at the Orphan Drug Summit in **July**[6](index=6&type=chunk) - Data included key insights from an ongoing Phase 1 proof-of-concept trial evaluating DNA-encoded monoclonal antibodies (DMAbs) for COVID-19[6](index=6&type=chunk) - Provided an overview of DNA-encoded protein technology (DPROT) that targets long-term protein expression[6](index=6&type=chunk) [General Corporate Developments](index=2&type=section&id=General%20Corporate%20Developments) INOVIO maintained its focus on financial discipline, directing resources towards the INO-3107 program, and strengthened its balance sheet through a public offering in July 2025, which generated approximately $22.5 million in net proceeds - Remains focused on financial discipline and directing resources to support the INO-3107 program[7](index=7&type=chunk) - Strengthened its balance sheet with an underwritten public offering of common stock and warrants in **July 2025**[7](index=7&type=chunk) - Net proceeds from the July 2025 offering were approximately **$22.5 million**[7](index=7&type=chunk) [Upcoming Presentations](index=2&type=section&id=Upcoming%20Presentations) INOVIO is scheduled to present data on INO-3107 and other promising DNA medicine candidates at several key industry conferences throughout October 2025 - INOVIO will present data on INO-3107 and other DNA medicine candidates at multiple upcoming events in **October 2025**, including the American Academy of Otolaryngology and World Vaccine Congress Europe[7](index=7&type=chunk)[10](index=10&type=chunk) [Second Quarter 2025 Financial Performance](index=2&type=section&id=Second%20Quarter%202025%20Financial%20Performance) INOVIO reported significantly reduced operating expenses and net loss for Q2 2025, with cash and investments supporting operations into Q2 2026 [Summary of Financial Results](index=2&type=section&id=Summary%20of%20Financial%20Results) For the second quarter of 2025, INOVIO reported a significant decrease in total operating expenses and a reduced net loss compared to the same period in 2024, driven by lower R&D and G&A expenditures Total Operating Expenses (Three Months Ended June 30) | Year | Amount (USD) | | :--- | :--- | | 2025 | $23.1 million | | 2024 | $33.3 million | | **Change (YoY)** | **↓ 30.6%** | Net Loss (Three Months Ended June 30) | Year | Amount (USD) | | :--- | :--- | | 2025 | $(23.5) million | | 2024 | $(32.2) million | | **Change (YoY)** | **↓ 27.0%** | Net Loss Per Share (Basic and Diluted, Three Months Ended June 30) | Year | Amount (USD) | | :--- | :--- | | 2025 | $(0.61) | | 2024 | $(1.19) | | **Change (YoY)** | **↓ 48.7%** | [Research and Development (R&D) Expenses](index=2&type=section&id=Research%20and%20Development%20(R%26D)%20Expenses) R&D expenses for Q2 2025 decreased substantially compared to Q2 2024, primarily due to reduced costs associated with drug manufacturing, clinical studies for INO-3107, and lower contract labor R&D Expenses (Three Months Ended June 30) | Year | Amount (USD) | | :--- | :--- | | 2025 | $14.5 million | | 2024 | $23.1 million | | **Change (YoY)** | **↓ 37.2%** | - The decrease was primarily a result of lower drug manufacturing, clinical study, and other expenses related to INO-3107, and lower contract labor[11](index=11&type=chunk) [General and Administrative (G&A) Expenses](index=2&type=section&id=General%20and%20Administrative%20(G%26A)%20Expenses) G&A expenses for Q2 2025 also saw a decrease year-over-year, mainly attributed to lower employee and consultant stock-based compensation, reduced outside services, and decreased contract labor G&A Expenses (Three Months Ended June 30) | Year | Amount (USD) | | :--- | :--- | | 2025 | $8.6 million | | 2024 | $10.2 million | | **Change (YoY)** | **↓ 15.7%** | - The decrease was primarily related to a decrease in employee and consultant stock-based compensation, lower outside services, and lower contract labor[11](index=11&type=chunk) [Cash, Cash Equivalents and Investments](index=3&type=section&id=Cash%2C%20Cash%20Equivalents%20and%20Investments) As of June 30, 2025, INOVIO's cash, cash equivalents, and short-term investments totaled $47.5 million, a decrease from $94.1 million at the end of 2024, excluding the net proceeds from the July 2025 public offering Cash, Cash Equivalents and Short-term Investments | Date | Amount (USD) | | :--- | :--- | | June 30, 2025 | $47.5 million | | December 31, 2024 | $94.1 million | | **Change** | **↓ 49.5%** | - This balance excludes net proceeds of approximately **$22.5 million** from the July 2025 public offering[7](index=7&type=chunk)[17](index=17&type=chunk) [Cash Guidance and Runway](index=3&type=section&id=Cash%20Guidance%20and%20Runway) INOVIO estimates that its current cash, cash equivalents, and short-term investments, including the July 2025 offering proceeds, will support operations into the second quarter of 2026, with an anticipated operational net cash burn of approximately $22 million for Q3 2025 - Current cash, cash equivalents, and short-term investments (including July 2025 offering proceeds) are estimated to support operations into the **second quarter of 2026**[13](index=13&type=chunk) - Operational net cash burn estimate for the third quarter of 2025 is approximately **$22 million**[13](index=13&type=chunk) [Consolidated Financial Statements](index=5&type=section&id=Consolidated%20Financial%20Statements) The consolidated financial statements present INOVIO's balance sheet and statements of operations, detailing assets, liabilities, equity, and financial performance for Q2 2025 and year-to-date [Consolidated Balance Sheets](index=5&type=section&id=Consolidated%20Balance%20Sheets) The consolidated balance sheets provide a detailed snapshot of INOVIO's financial position, showing total assets, liabilities, and stockholders' equity as of June 30, 2025, and December 31, 2024, reflecting a decrease in total assets and liabilities over the period Consolidated Balance Sheet Highlights | Metric | June 30, 2025 (USD) | December 31, 2024 (USD) | Change | | :--- | :--- | :--- | :--- | | Total current assets | $52,697,149 | $97,830,050 | ↓ 46.2% | | Total assets | $68,240,504 | $113,197,206 | ↓ 39.7% | | Total current liabilities | $31,707,610 | $35,325,584 | ↓ 10.2% | | Total liabilities | $39,709,599 | $44,693,411 | ↓ 11.1% | | Total Stockholders' Equity | $28,530,905 | $68,503,795 | ↓ 58.4% | [Consolidated Statements of Operations](index=7&type=section&id=Consolidated%20Statements%20of%20Operations) The consolidated statements of operations detail INOVIO's financial performance for the three and six months ended June 30, 2025, and 2024, illustrating reduced operating expenses and a lower net loss across both periods compared to the prior year Consolidated Statements of Operations Highlights (Three Months Ended June 30) | Metric | 2025 (USD) | 2024 (USD) | Change (YoY) | | :--- | :--- | :--- | :--- | | Revenue from collaborative arrangement | $— | $100,762 | ↓ 100% | | Research and development | $14,521,407 | $23,090,989 | ↓ 37.1% | | General and administrative | $8,563,112 | $10,206,686 | ↓ 16.1% | | Total operating expenses | $23,084,519 | $33,297,675 | ↓ 30.6% | | Loss from operations | $(23,084,519) | $(33,196,913) | ↓ 30.5% | | Net loss | $(23,519,412) | $(32,237,098) | ↓ 27.0% | | Net loss per share (Basic and diluted) | $(0.61) | $(1.19) | ↓ 48.7% | Consolidated Statements of Operations Highlights (Six Months Ended June 30) | Metric | 2025 (USD) | 2024 (USD) | Change (YoY) | | :--- | :--- | :--- | :--- | | Revenue from collaborative arrangement | $65,343 | $100,762 | ↓ 35.2% | | Research and development | $30,612,309 | $44,001,307 | ↓ 30.4% | | General and administrative | $17,588,082 | $20,781,337 | ↓ 15.4% | | Total operating expenses | $48,200,391 | $64,782,644 | ↓ 25.6% | | Loss from operations | $(48,135,048) | $(64,681,882) | ↓ 25.6% | | Net loss | $(43,214,109) | $(62,706,969) | ↓ 31.1% | | Net loss per share (Basic and diluted) | $(1.12) | $(2.48) | ↓ 54.9% | [Company Information](index=3&type=section&id=Company%20Information) This section provides an overview of INOVIO's proprietary DNA medicines platform and its mission to develop treatments for HPV-related diseases, cancer, and infectious diseases [About INOVIO's DNA Medicines Platform](index=3&type=section&id=About%20INOVIO%27s%20DNA%20Medicines%20Platform) INOVIO's DNA medicines platform utilizes precisely designed DNA plasmids, delivered by its proprietary CELLECTRA investigational medical device, to enable the body's cells to produce specific disease-fighting proteins without the need for chemical adjuvants or viral vectors - INOVIO's DNA medicines platform comprises precisely designed DNA plasmids and its proprietary investigational medical device, CELLECTRA[15](index=15&type=chunk) - DNA plasmids function like software, allowing the body's cells to produce specific proteins to target and fight disease[15](index=15&type=chunk) - CELLECTRA delivery devices are designed to optimally deliver DNA medicines without chemical adjuvants, lipid nanoparticles, or the risk of anti-vector response[15](index=15&type=chunk) [About INOVIO](index=3&type=section&id=About%20INOVIO) INOVIO is a biotechnology company dedicated to developing and commercializing DNA medicines for HPV-related diseases, cancer, and infectious diseases, by leveraging technology that empowers the body to generate its own disease-fighting mechanisms - INOVIO is a biotechnology company focused on developing and commercializing DNA medicines[16](index=16&type=chunk) - Its DNA medicines aim to treat and protect people from HPV-related diseases, cancer, and infectious diseases[16](index=16&type=chunk) - The technology optimizes the design and delivery of DNA medicines to teach the body to manufacture its own disease-fighting tools[16](index=16&type=chunk) [Important Disclosures](index=4&type=section&id=Important%20Disclosures) This section includes important forward-looking statements regarding INOVIO's business and provides contact information for media and investor inquiries [Forward-Looking Statements](index=4&type=section&id=Forward-Looking%20Statements) This press release contains forward-looking statements regarding INOVIO's business, including clinical trials, regulatory submissions, commercialization, and financial projections, which are subject to inherent risks and uncertainties that could cause actual results to differ materially from expectations - The press release contains forward-looking statements related to business plans, clinical trials, BLA submission, commercial launch, and cash resource sufficiency[18](index=18&type=chunk) - Actual events or results may differ from expectations due to uncertainties inherent in preclinical studies, clinical trials, product development, funding availability, and regulatory approvals[18](index=18&type=chunk) [Contacts](index=4&type=section&id=Contacts) Contact information is provided for media and investor relations inquiries - Media Contact: Jennie Willson, (267) 429-8567, communications@inovio.com[19](index=19&type=chunk) - Investors Contact: Peter Vozzo - ICR Healthcare, (443) 213-0505, investor.relations@inovio.com[19](index=19&type=chunk)

[Executive Summary & Key Highlights](index=1&type=section&id=Executive%20Summary%20%26%20Key%20Highlights) [Q2 2025 Performance Overview](index=1&type=section&id=Q2%202025%20Performance%20Overview) NeuroPace reported **record quarterly revenue** of **$23.5 million** in Q2 2025, a **22%** year-over-year increase, and subsequently raised its **full-year 2025 revenue guidance** to between **$94 million** and **$98 million**, while also increasing its **gross margin guidance** and confirming CMS maintains current MS-DRG assignment for RNS System procedures, ensuring **reimbursement stability**, with NAUTILUS data on track for FDA submission for IGE indication expansion - Reported **record quarterly revenue** of **$23.5 million** in Q2 2025[1](index=1&type=chunk) - Increased **full-year 2025 revenue guidance** to between **$94 million** and **$98 million**[2](index=2&type=chunk) - Increased **gross margin guidance** to between **75%** and **76%**[2](index=2&type=chunk) - CMS maintains current MS-DRG assignment for RNS System® procedures, preserving **reimbursement stability**[2](index=2&type=chunk)[5](index=5&type=chunk) - Remain on track to submit NAUTILUS data to FDA for potential IGE indication expansion in the second half of 2025[2](index=2&type=chunk) [Financial Highlights](index=1&type=section&id=Financial%20Highlights) NeuroPace's Q2 2025 revenue grew **22%** year-over-year to **$23.5 million**, with RNS System revenue increasing **16%** in Q2 and **21%** in the first half of 2025, achieving a strong gross margin of **77.1%** due to manufacturing efficiencies and a positive product mix, and successfully refinanced its existing debt into a new **$75 million** credit facility Q2 2025 Revenue and Gross Margin Highlights | Metric | Q2 2025 | YoY Growth | | :------------------- | :-------- | :--------- | | Revenue | $23.5 million | 22% | | RNS System Revenue (Q2) | N/A | 16% | | RNS System Revenue (H1) | N/A | 21% | | Gross Margin | 77.1% | N/A | - Refinanced existing debt into a new **$75 million** credit facility with MidCap Financial at **favorable terms**[5](index=5&type=chunk) [Operational & Strategic Highlights](index=1&type=section&id=Operational%20%26%20Strategic%20Highlights) The NAUTILUS study for RNS therapy in IGE demonstrated a **statistically significant safety profile** and **clinically meaningful improvement** in secondary effectiveness endpoints, including a **79%** median GTC seizure reduction at 12 months, while NeuroPace also saw **increased momentum** from Project CARE, achieved **record highs** in active accounts and prescribers, and secured a favorable CMS outcome for RNS procedures - Announced compelling one-year preliminary data from the NAUTILUS study evaluating RNS therapy in IGE, demonstrating a **statistically significant safety profile** and **clinically meaningful improvement** across multiple prespecified secondary effectiveness endpoints, including **79%** median GTC seizure reduction at 12 months[5](index=5&type=chunk) - Built on Project CARE **momentum** with an increasing contribution in the second quarter compared with the first quarter of 2025[5](index=5&type=chunk) - Achieved **record highs** in number of both active accounts and prescribers[5](index=5&type=chunk) [CEO Commentary](index=1&type=section&id=CEO%20Commentary) CEO Joel Becker highlighted the company's continued momentum in Q2 2025, emphasizing significant progress in key initiatives for sustained long-term growth, including advancing RNS therapy access and adoption, supporting operating leverage, and making important clinical, regulatory, and R&D advancements, such as the NAUTILUS and pediatric PMA supplement programs, and AI software development - Advancing strategy to drive increased access to and adoption of RNS therapy and supporting operating leverage as the company scales[4](index=4&type=chunk) - Made important clinical and regulatory and research and development progress, including advancing NAUTILUS and pediatric PMA supplement programs[4](index=4&type=chunk) - Advancing AI software development programs, reflecting **leadership in the field** and commitment to addressing **unmet patient needs**[6](index=6&type=chunk) [Detailed Financial Results](index=2&type=section&id=Detailed%20Financial%20Results) [Second Quarter 2025 Financial Results](index=2&type=section&id=Second%20Quarter%202025%20Financial%20Results) NeuroPace reported Q2 2025 total revenue of **$23.5 million**, a **22%** increase year-over-year, **primarily driven by** RNS System sales, with gross margin improving to **77.1%**, total operating expenses rising to **$25.0 million** largely due to **one-time personnel costs**, resulting in a net loss of **$8.7 million**, and the company ending the quarter with **$62.1 million** in cash, cash equivalents, and short-term investments, and improved free cash flow to (**$2.3 million**) Q2 2025 Key Financial Metrics | Metric | Q2 2025 (in thousands) | Q2 2024 (in thousands) | YoY Change | | :------------------------- | :--------------------- | :--------------------- | :--------- | | Total Revenue | $23,520 | $19,256 | +22.1% | | Gross Margin | 77.1% | 73.4% | +3.7 ppts | | Total Operating Expenses | $24,956 | $20,364 | +22.5% | | Loss from Operations | $(6,824) | $(6,230) | +9.5% | | Net Loss | $(8,651) | $(7,514) | +15.1% | | Net Loss Per Share (basic & diluted) | $(0.26) | $(0.26) | 0% | - Revenue growth **primarily driven by** increased sales of the RNS System and meaningful revenue from SEEG products[6](index=6&type=chunk) - Total operating expenses increase largely driven by **one-time personnel expenses** totaling **$1.9 million**, including severance and recruiting, and **$1.6 million** in personnel-related expenses for an executive transition[7](index=7&type=chunk)[8](index=8&type=chunk) Cash and Debt Position (as of June 30, 2025) | Metric | Amount (in millions) | | :-------------------------------------- | :------------------- | | Cash, cash equivalents and short-term investments | $62.1 | | Long-term borrowings | $58.6 | | Free cash flow (Q2 2025) | ($2.3) | | Free cash flow (Q2 2024) | ($4.0) | [Updated Full Year 2025 Financial Guidance](index=2&type=section&id=Updated%20Full%20Year%202025%20Financial%20Guidance) NeuroPace has increased its **full-year 2025 total revenue guidance** to between **$94 million** and **$98 million**, representing **18%-23%** growth over 2024, and raised its **gross margin guidance** to **75%-76%**, while maintaining its total operating expenses guidance range of **$92 million** to **$95 million** Updated Full Year 2025 Financial Guidance | Metric | Previous Guidance | Updated Guidance | YoY Growth (vs. $79.9M in 2024) | | :----------------------- | :---------------- | :--------------- | :------------------------------ | | Total Revenue | $93M - $97M | $94M - $98M | 18% - 23% | | Gross Margin | 73% - 75% | 75% - 76% | N/A | | Total Operating Expenses | $92M - $95M | $92M - $95M | N/A | - Total operating expenses guidance includes approximately **$11 million** in stock-based compensation, a **non-cash expense**[12](index=12&type=chunk) [Company Information](index=2&type=section&id=Company%20Information) [Webcast and Conference Call Information](index=2&type=section&id=Webcast%20and%20Conference%20Call%20Information) NeuroPace hosted a conference call on August 12, 2025, to discuss its second quarter 2025 financial results, with details for accessing the live and archived webcast, as well as participating via telephone, provided - Conference call held on Tuesday, August 12, 2025, at **4:30 P.M. Eastern Time**[11](index=11&type=chunk) - Live and archived webcast available at https://viavid.webcasts.com/starthere.jsp?ei=1724652&tp_key=858d589533[11](index=11&type=chunk) - Webcast will be archived on the Company's investor relations website for at least **90 days**[11](index=11&type=chunk) [About NeuroPace, Inc.](index=3&type=section&id=About%20NeuroPace%2C%20Inc.) NeuroPace, Inc. is a medical device company based in Mountain View, Calif., dedicated to improving the lives of individuals with epilepsy by reducing or eliminating debilitating seizures, with its RNS System being the first and only commercially available, brain-responsive platform that delivers personalized, real-time treatment at the seizure source, aiming to establish a new standard of care for drug-resistant epilepsy and potentially other brain disorders - NeuroPace is a medical device company focused on transforming the lives of people living with epilepsy[13](index=13&type=chunk) - Its RNS System is the first and only commercially available, brain-responsive platform that delivers personalized, real-time treatment at the seizure source[13](index=13&type=chunk) - The platform aims to drive a better standard of care for patients with drug-resistant epilepsy and has potential for other brain disorders[13](index=13&type=chunk) [Forward-Looking Statements](index=3&type=section&id=Forward-Looking%20Statements) This section contains forward-looking statements regarding NeuroPace's future plans, including **potential indication expansion** for its RNS System, **increased adoption** of RNS therapy, and anticipated financial performance for 2025, cautioning investors that actual results may **materially differ** from these statements due to various risks, such as market acceptance, regulatory compliance, and product development challenges, as detailed in the company's SEC filings - Statements include expectations regarding **potential indication expansion** for the RNS System and software/product development efforts[14](index=14&type=chunk) - Includes expectations for increasing access to and adoption of RNS therapy, and the ability to maintain or increase gross margin[14](index=14&type=chunk) - Anticipated revenue, gross margin, and operating expenses for the year ending 2025 are forward-looking[14](index=14&type=chunk) - Actual results or events could **materially differ** due to various factors, including market acceptance, regulatory risks, and operating expenses, as described in SEC filings[14](index=14&type=chunk) [Investor Contact](index=3&type=section&id=Investor%20Contact) This section provides contact information for NeuroPace's investor relations, including the Head of Investor Relations, Scott Schaper, and general investor email addresses - Investor Contact: Scott Schaper, Head of Investor Relations[15](index=15&type=chunk) - Email contacts: sschaper@neuropace.com and investors@neuropace.com[15](index=15&type=chunk) [Condensed Financial Statements](index=4&type=section&id=Condensed%20Financial%20Statements) [Condensed Statements of Operations](index=4&type=section&id=Condensed%20Statements%20of%20Operations) The unaudited condensed statements of operations detail NeuroPace's financial performance for the three and six months ended June 30, 2025, and 2024, presenting key figures such as revenue, cost of goods sold, gross profit, operating expenses, loss from operations, and net loss Condensed Statements of Operations (Unaudited) | (in thousands, except share and per share amounts) | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :------------------------------------------------- | :------------------------------- | :------------------------------- | :------------------------------- | :------------------------------- | | Revenue | $23,520 | $19,256 | $46,044 | $37,380 | | Cost of goods sold | $5,388 | $5,122 | $10,570 | $9,903 | | Gross profit | $18,132 | $14,134 | $35,474 | $27,477 | | Sales and marketing | $12,043 | $9,756 | $23,046 | $19,789 | | Research and development | $6,845 | $6,065 | $14,285 | $11,849 | | General and administrative | $6,068 | $4,543 | $10,114 | $9,614 | | Total operating expenses | $24,956 | $20,364 | $47,445 | $41,252 | | Loss from operations | $(6,824) | $(6,230) | $(11,971) | $(13,775) | | Net loss and comprehensive loss | $(8,651) | $(7,514) | $(15,240) | $(16,439) | | Net loss per share attributable to common stockholders, basic and diluted | $(0.26) | $(0.26) | $(0.47) | $(0.58) | [Condensed Balance Sheets](index=5&type=section&id=Condensed%20Balance%20Sheets) The unaudited condensed balance sheets provide a snapshot of NeuroPace's financial position as of June 30, 2025, and December 31, 2024, detailing current and total assets, current and long-term liabilities, and stockholders' equity Condensed Balance Sheets (Unaudited) | (in thousands, except share and per share amounts) | June 30, 2025 | December 31, 2024 | | :------------------------------------------------- | :------------ | :---------------- | | **Assets** | | | | Cash and cash equivalents | $22,857 | $13,430 | | Short-term investments | $39,284 | $39,325 | | Total current assets | $93,742 | $81,339 | | Total assets | $106,114 | $94,647 | | **Liabilities and Stockholders' Equity** | | | | Accounts payable | $4,721 | $2,954 | | Total current liabilities | $17,143 | $15,156 | | Long-term debt | $58,616 | $59,525 | | Total liabilities | $86,676 | $86,634 | | Total stockholders' equity | $19,438 | $8,013 |