Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Commission File Number 001-38906 ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2025 IMMUNOVANT, INC. (Exact name of registrant as specified in its charter) Delaware 83-2771572 (State or other jurisdiction of incorporation o ...

[FORM 10-Q Filing Information](index=1&type=section&id=FORM%2010-Q) This section provides basic identification details for Sionna Therapeutics, Inc.'s Form 10-Q filing for the quarterly period ended June 30, 2025 [Registrant Information](index=1&type=section&id=Registrant%20Information) This section provides the basic identification details for Sionna Therapeutics, Inc.'s Form 10-Q filing for the quarterly period ended June 30, 2025, including its address, telephone number, and Nasdaq Global Market trading symbol 'SION', classifying the company as a non-accelerated filer, a smaller reporting company, and an emerging growth company - Sionna Therapeutics, Inc. is filing its Quarterly Report on Form 10-Q for the period ended June 30, 2025[2](index=2&type=chunk) - The number of shares of registrant's common stock outstanding as of August 1, 2025, was **44,139,823**[5](index=5&type=chunk) Trading Symbol Information | Title of each class | Trading Symbol(s) | Name of each exchange on which registered | | :------------------ | :---------------- | :---------------------------------------- | | Common Stock, $0.001 par value per share | SION | The Nasdaq Global Market | Filer Status | Filer Status | | | :---------------------- | :--- | | Large accelerated filer | o | | Accelerated filer | o | | Non-accelerated filer | x | | Smaller reporting company | x | | Emerging growth company | x | [Cautionary Note Regarding Forward-Looking Statements](index=2&type=section&id=CAUTIONARY%20NOTE%20REGARDING%20FORWARD-LOOKING%20STATEMENTS) This section cautions readers about forward-looking statements in the report, which involve substantial risks and uncertainties [Nature of Forward-Looking Statements](index=2&type=section&id=Nature%20of%20Forward-Looking%20Statements) This section highlights that the report contains forward-looking statements involving substantial risks and uncertainties, cautioning that actual results may differ materially - The Quarterly Report contains forward-looking statements about the company and its industry, involving substantial risks and uncertainties, made pursuant to safe harbor provisions[8](index=8&type=chunk) - Statements cover future results of operations, financial position, business strategy, product candidates, preclinical studies, clinical trials, research and development costs, regulatory approvals, commercial strategy, timing and likelihood of success, and management plans[8](index=8&type=chunk) - Actual results, performance, or achievements may be materially different from those expressed or implied by forward-looking statements due to known and unknown risks, uncertainties, and other important factors beyond the company's control[8](index=8&type=chunk) [Key Areas of Forward-Looking Statements](index=2&type=section&id=Key%20Areas%20of%20Forward-Looking%20Statements) This section details specific forward-looking statements regarding R&D, clinical trials, regulatory approvals, funding, market potential, and intellectual property - Initiation, timing, progress, and results of research and development programs, preclinical studies, and clinical trials[10](index=10&type=chunk) - Ability of clinical trials to demonstrate safety and efficacy of product candidates[10](index=10&type=chunk) - Timing, scope, and likelihood of regulatory filings and approvals[10](index=10&type=chunk) - Implementation of business model and strategic plans for product candidates[10](index=10&type=chunk) - Ability to obtain additional cash and sufficiency of existing cash to fund operations[10](index=10&type=chunk) - Accuracy of estimates regarding expenses, future revenue, capital requirements, and financing needs[10](index=10&type=chunk) - Size and growth potential of markets for product candidates and manufacturing capabilities[10](index=10&type=chunk) - Scope of intellectual property protection[10](index=10&type=chunk) - Developments relating to competitors and industry[10](index=10&type=chunk) - Existing regulations and regulatory developments, including changes in U.S. federal policy[10](index=10&type=chunk) - Expectations regarding future events under collaboration and licensing agreements[10](index=10&type=chunk) - General economic, industry, and market conditions, including elevated interest rates and inflation[10](index=10&type=chunk) - Ability to attract and retain key personnel[10](index=10&type=chunk) - Expectations regarding emerging growth company status[10](index=10&type=chunk) - Anticipated use of existing cash, cash equivalents, and marketable securities[10](index=10&type=chunk) - These statements are based on current expectations and projections but are not guarantees of future performance and are subject to risks described in the 'Risk Factors' section[9](index=9&type=chunk)[11](index=11&type=chunk) [Note Regarding Trademarks](index=4&type=section&id=NOTE%20REGARDING%20TRADEMARKS) This section clarifies the ownership and usage of trademarks within the report, including company and third-party marks [Trademark Ownership and Usage](index=4&type=section&id=Trademark%20Ownership%20and%20Usage) This section clarifies Sionna Therapeutics, Inc.'s trademark ownership and usage, noting that other trademarks belong to third parties - Sionna Therapeutics, Inc. owns the trademarks SIONNA and SIONNA THERAPEUTICS, and other design trademarks[15](index=15&type=chunk) - The absence of ™ and ® symbols does not indicate a lack of trademark rights[15](index=15&type=chunk) - References to 'Sionna,' 'Company,' 'we,' 'us,' and 'our' refer to Sionna Therapeutics, Inc. and its subsidiary[16](index=16&type=chunk) [Summary of Material Risks Associated with Our Business](index=5&type=section&id=SUMMARY%20OF%20MATERIAL%20RISKS%20ASSOCIATED%20WITH%20OUR%20BUSINESS) This section provides a high-level overview of the significant risks inherent in the company's business operations and financial outlook [Key Business Risks](index=5&type=section&id=Key%20Business%20Risks) This section summarizes key risks including operating losses, funding needs, dependence on NBD1 stabilizers, regulatory uncertainties, competition, and stock volatility - Incurred significant operating losses since inception, with net losses of **$34.6 million** and **$20.4 million** for the six months ended June 30, 2025, and 2024, respectively, and an accumulated deficit of **$215.6 million** as of June 30, 2025[18](index=18&type=chunk) - Requires substantial additional funding for product development and commercialization, with potential inability to raise capital on acceptable terms[19](index=19&type=chunk) - Substantially dependent on the success of NBD1 stabilizers; failure or delays would materially harm the business[19](index=19&type=chunk) - Developing combination treatments increases complexity and risk, including drug-drug interactions and unforeseen side effects[19](index=19&type=chunk) - Regulatory approval processes are lengthy, time-consuming, and unpredictable; failure to obtain approval would substantially harm the business[19](index=19&type=chunk) - Preclinical and interim clinical trial results are not necessarily predictive of later clinical trial outcomes[19](index=19&type=chunk) - Targeting the NBD1 domain of CFTR protein is novel, with no guarantee of successful product development[19](index=19&type=chunk) - Clinical trials may fail to demonstrate safety and efficacy, or identify serious adverse side effects[19](index=19&type=chunk) - Must prioritize development of certain product candidates due to limited resources, potentially missing more profitable opportunities[19](index=19&type=chunk) - Dependent on licensed intellectual property; loss of rights or breach of agreements could prevent development/commercialization[19](index=19&type=chunk) - Relies on third parties for manufacturing, increasing risks of insufficient quantities, unacceptable cost, or quality[19](index=19&type=chunk) - Inability to obtain, maintain, and enforce intellectual property rights could allow competitors to commercialize similar products[19](index=19&type=chunk) - Faces substantial competition, particularly from Vertex, which holds significant market share and greater resources[21](index=21&type=chunk) - The trading price of common stock may be volatile, leading to potential investment loss[21](index=21&type=chunk) [Part I - Financial Information](index=8&type=section&id=Part%20I%20-%20Financial%20Information) This section presents the unaudited interim condensed consolidated financial statements and management's discussion and analysis [Item 1. Financial Statements (Unaudited)](index=8&type=section&id=Item%201.%20Financial%20Statements%20(Unaudited)) This section presents the unaudited interim condensed consolidated financial statements, including balance sheets, statements of operations, equity, and cash flows [Condensed Consolidated Balance Sheets](index=9&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) This section provides a snapshot of the company's assets, liabilities, and equity at specific points in time Condensed Consolidated Balance Sheets (in thousands) | Assets (June 30, 2025) | Amount ($) | Assets (December 31, 2024) | Amount ($) | | :----------------------- | :--------- | :--------------------------- | :--------- | | Cash and cash equivalents | 40,985 | Cash and cash equivalents | 37,788 | | Marketable securities, current | 221,586 | Marketable securities, current | 109,750 | | Prepaid expenses and other current assets | 4,175 | Prepaid expenses and other current assets | 3,455 | | **Total current assets** | **266,746** | **Total current assets** | **150,993** | | Property and equipment, net | 2,246 | Property and equipment, net | 2,466 | | Marketable securities, noncurrent | 74,699 | Marketable securities, noncurrent | 20,505 | | Restricted cash | 962 | Restricted cash | 962 | | Operating lease right-of-use asset | 7,395 | Operating lease right-of-use asset | 7,832 | | Other assets | — | Other assets | 2,994 | | **Total assets** | **352,048** | **Total assets** | **185,752** | | Liabilities (June 30, 2025) | Amount ($) | Liabilities (December 31, 2024) | Amount ($) | | Accounts payable | 914 | Accounts payable | 1,186 | | Accrued expenses | 5,468 | Accrued expenses | 8,162 | | Operating lease liability, current | 1,168 | Operating lease liability, current | 1,072 | | **Total current liabilities** | **7,550** | **Total current liabilities** | **10,420** | | Operating lease liability, noncurrent | 8,069 | Operating lease liability, noncurrent | 8,677 | | **Total liabilities** | **15,619** | **Total liabilities** | **19,097** | | Total convertible preferred stock | — | Total convertible preferred stock | 330,368 | | Stockholders' equity (deficit) | 336,429 | Stockholders' equity (deficit) | (163,713) | | **Total liabilities, convertible preferred stock and stockholders' equity (deficit)** | **352,048** | **Total liabilities, convertible preferred stock and stockholders' equity (deficit)** | **185,752** | - Total assets increased significantly from **$185.8 million** at December 31, 2024, to **$352.0 million** at June 30, 2025, primarily driven by an increase in marketable securities[29](index=29&type=chunk) - Total liabilities decreased from **$19.1 million** to **$15.6 million**, while stockholders' equity shifted from a deficit of **$163.7 million** to a positive **$336.4 million**, largely due to the IPO and conversion of preferred stock[29](index=29&type=chunk) [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=11&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) This section details the company's revenues, expenses, and net loss over specific reporting periods Condensed Consolidated Statements of Operations and Comprehensive Loss (in thousands) | Metric | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :----------------------------------- | :------------------------------- | :------------------------------- | :------------------------------- | :------------------------------- | | Research and development | $15,383 | $8,233 | $29,051 | $18,453 | | General and administrative | $6,523 | $3,059 | $12,514 | $5,986 | | **Total operating expenses** | **$21,906** | **$11,292** | **$41,565** | **$24,439** | | Loss from operations | $(21,906) | $(11,292) | $(41,565) | $(24,439) | | Interest income | $3,667 | $2,566 | $6,667 | $3,698 | | Other income | $171 | $174 | $348 | $342 | | **Total other income** | **$3,838** | **$2,740** | **$7,015** | **$4,040** | | **Net loss** | **$(18,068)** | **$(8,552)** | **$(34,550)** | **$(20,399)** | | Net loss per share, basic and diluted | $(0.41) | $(2.71) | $(0.98) | $(6.54) | | Weighted-average common shares outstanding | 44,116,997 | 3,159,815 | 35,404,928 | 3,121,225 | | Unrealized loss on marketable securities | $(118) | $(148) | $(185) | $(156) | | **Comprehensive loss** | **$(18,186)** | **$(8,700)** | **$(34,735)** | **$(20,555)** | - Net loss for the six months ended June 30, 2025, increased to **$34.6 million** from **$20.4 million** in the prior year, driven by higher operating expenses[31](index=31&type=chunk) - Research and development expenses increased by **$10.6 million (57.4%)** and general and administrative expenses increased by **$6.5 million (109.0%)** for the six months ended June 30, 2025, compared to the same period in 2024[31](index=31&type=chunk) - Interest income significantly increased to **$6.7 million** for the six months ended June 30, 2025, from **$3.7 million** in 2024, due to increased investment in debt securities following the IPO[31](index=31&type=chunk) [Condensed Consolidated Statements of Convertible Preferred Stock and Stockholders' Equity (Deficit)](index=12&type=section&id=Condensed%20Consolidated%20Statements%20of%20Convertible%20Preferred%20Stock%20and%20Stockholders'%20Equity%20(Deficit)) This section outlines changes in the company's equity structure, including preferred stock conversion and IPO impact - Upon the closing of the initial public offering in February 2025, all outstanding convertible preferred stock (Series Seed, A, B, C) automatically converted into **27,149,206** shares of common stock[36](index=36&type=chunk)[42](index=42&type=chunk) - The IPO also resulted in the issuance of **12,176,467** shares of common stock, generating net proceeds of approximately **$199.6 million**[36](index=36&type=chunk)[42](index=42&type=chunk) - Total stockholders' equity (deficit) dramatically improved from a deficit of **$(163.7 million)** at December 31, 2024, to a positive **$336.4 million** at June 30, 2025[36](index=36&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=14&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) This section presents the inflows and outflows of cash from operating, investing, and financing activities Condensed Consolidated Statements of Cash Flows (in thousands) | Cash Flow Activity | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :----------------------------------- | :------------------------------- | :------------------------------- | | Net cash used in operating activities | $(34,441) | $(23,320) | | Net cash used in investing activities | $(164,439) | $(152,548) | | Net cash provided by financing activities | $202,077 | $181,371 | | **Net increase in cash, cash equivalents and restricted cash** | **$3,197** | **$5,503** | - Net cash used in operating activities increased to **$34.4 million** for the six months ended June 30, 2025, from **$23.3 million** in the prior year, primarily due to increased net loss[38](index=38&type=chunk)[118](index=118&type=chunk)[119](index=119&type=chunk) - Net cash provided by financing activities was **$202.1 million** in 2025, mainly from the IPO, compared to **$181.4 million** in 2024 from Series C convertible preferred stock issuance[38](index=38&type=chunk)[121](index=121&type=chunk) - Cash, cash equivalents, and restricted cash at the end of the period were **$41.9 million** in 2025, a slight decrease from **$45.0 million** in 2024[38](index=38&type=chunk) [Notes to Condensed Consolidated Financial Statements](index=15&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) This section provides detailed explanations and additional information supporting the condensed consolidated financial statements [1. Nature of the Business](index=15&type=section&id=1.%20Nature%20of%20the%20Business) This note describes Sionna Therapeutics, Inc.'s core focus, recent corporate actions, and financial viability - Sionna Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing novel medicines to normalize CFTR protein function for cystic fibrosis patients[39](index=39&type=chunk) - The company completed a **1-for-1.4611** reverse stock split on January 31, 2025, and an Initial Public Offering (IPO) in February 2025, raising approximately **$199.6 million** net proceeds[41](index=41&type=chunk)[42](index=42&type=chunk) - As of June 30, 2025, the company had an accumulated deficit of **$215.6 million** but believes its existing cash, cash equivalents, and marketable securities of **$337.3 million** will fund operations beyond twelve months[44](index=44&type=chunk)[45](index=45&type=chunk) [2. Summary of Significant Accounting Policies](index=16&type=section&id=2.%20Summary%20of%20Significant%20Accounting%20Policies) This note outlines the key accounting principles and recent pronouncements relevant to the financial statements - No material changes to significant accounting policies since the Annual Report on Form 10-K for the year ended December 31, 2024[46](index=46&type=chunk) - The interim financial statements are unaudited and prepared on the same basis as audited annual statements, reflecting normal recurring adjustments[47](index=47&type=chunk) - ASU 2023-09 (Income Taxes): Effective for annual periods after December 15, 2024; not expected to have a material impact[48](index=48&type=chunk) - ASU 2024-03 (Income Statement Expenses): Effective for annual periods after December 15, 2026; currently evaluating the effect[49](index=49&type=chunk) [3. Marketable Securities](index=17&type=section&id=3.%20Marketable%20Securities) This note details the composition and fair value of the company's marketable securities portfolio Marketable Securities (in thousands) | Category | June 30, 2025 Fair Value ($) | December 31, 2024 Fair Value ($) | | :----------------------------- | :----------------------------- | :----------------------------- | | U.S. Treasury securities | 183,705 | 70,679 | | Commercial paper | 61,638 | 5,934 | | Government agency securities | 37,870 | 36,415 | | Corporate debt | 13,072 | 17,227 | | **Total marketable securities** | **296,285** | **130,255** | - Total marketable securities increased significantly from **$130.3 million** at December 31, 2024, to **$296.3 million** at June 30, 2025[50](index=50&type=chunk) - As of June 30, 2025, **$74.7 million** of marketable securities had remaining maturities between one and two years; all others matured in less than a year. No realized gains or losses were recorded in either period[50](index=50&type=chunk) [4. Fair Value Measurements](index=18&type=section&id=4.%20Fair%20Value%20Measurements) This note describes the fair value hierarchy and measurements applied to the company's financial assets Fair Value Measurements of Financial Assets (in thousands) | Asset Category | June 30, 2025 Total Fair Value ($) | December 31, 2024 Total Fair Value ($) | | :----------------------- | :--------------------------------- | :--------------------------------- | | Money market funds | 40,485 | 37,288 | | U.S. Treasury securities | 183,705 | 70,679 | | Commercial paper | 61,638 | 5,934 | | Government agency securities | 37,870 | 36,415 | | Corporate debt | 13,072 | 17,227 | | **Total financial assets** | **336,770** | **167,543** | - Total financial assets measured at fair value increased from **$167.5 million** at December 31, 2024, to **$336.8 million** at June 30, 2025[52](index=52&type=chunk) - The majority of assets are classified as Level 1 (money market funds, U.S. Treasury securities) or Level 2 (commercial paper, government agency securities, corporate debt) in the fair value hierarchy[52](index=52&type=chunk) [5. Property and Equipment, net](index=18&type=section&id=5.%20Property%20and%20Equipment,%20net) This note provides details on the company's property and equipment, including depreciation Property and Equipment, net (in thousands) | Category | June 30, 2025 ($) | December 31, 2024 ($) | | :----------------------- | :---------------- | :-------------------- | | Leasehold improvements | 1,854 | 1,854 | | Laboratory equipment | 1,547 | 1,461 | | Furniture & fixtures | 722 | 722 | | **Total property and equipment** | **4,123** | **4,037** | | Less: accumulated depreciation | (1,877) | (1,571) | | **Property and equipment, net** | **2,246** | **2,466** | - Net property and equipment decreased from **$2.47 million** at December 31, 2024, to **$2.25 million** at June 30, 2025[53](index=53&type=chunk) - Depreciation expense was **$0.3 million** for both the six months ended June 30, 2025, and 2024[53](index=53&type=chunk) [6. Accrued Expenses](index=19&type=section&id=6.%20Accrued%20Expenses) This note details the composition and changes in the company's accrued expenses Accrued Expenses (in thousands) | Category | June 30, 2025 ($) | December 31, 2024 ($) | | :----------------------------- | :---------------- | :-------------------- | | Accrued research and development | 2,660 | 3,961 | | Accrued compensation and benefits | 1,991 | 2,972 | | Accrued professional fees | 782 | 737 | | Accrued other | 35 | — | | Accrued offering costs | — | 492 | | **Total accrued expenses** | **5,468** | **8,162** | - Total accrued expenses decreased from **$8.16 million** at December 31, 2024, to **$5.47 million** at June 30, 2025, primarily due to decreases in accrued research and development and compensation and benefits, and the payment of accrued offering costs[54](index=54&type=chunk) [7. Commitments and Contingencies](index=19&type=section&id=7.%20Commitments%20and%20Contingencies) This note outlines the company's operating lease commitments, legal proceedings, and indemnification obligations - No material changes to operating lease commitments during the six months ended June 30, 2025[55](index=55&type=chunk) - The company was not subject to any material legal proceedings as of June 30, 2025, and is not aware of any pending or threatened[56](index=56&type=chunk) - The company provides indemnification to vendors, lessors, business partners, directors, and senior management, with potential unlimited future payments, but has not incurred material costs to date[59](index=59&type=chunk) [8. License Agreements](index=19&type=section&id=8.%20License%20Agreements) This note describes the company's various third-party license agreements and their financial implications - The company has various license agreements with third parties involving upfront, milestone, and royalty payments[60](index=60&type=chunk) - No material changes to the terms, conditions, or accounting conclusions of these license agreements since the Annual Report[60](index=60&type=chunk) [9. Stock-Based Compensation](index=20&type=section&id=9.%20Stock-Based%20Compensation) This note details the company's stock option plans and the associated compensation expense - The 2020 Stock Option and Grant Plan has no shares remaining for future issuance as of June 30, 2025[61](index=61&type=chunk) - The 2025 Stock Option and Incentive Plan became effective in February 2025, initially reserving **5,060,000** shares, subject to evergreen provisions[62](index=62&type=chunk) Stock Option Activity (Six Months Ended June 30, 2025) | Metric | Number of Common Stock Options | Weighted-Average Exercise Price ($) | | :----------------------------- | :----------------------------- | :---------------------------------- | | Outstanding as of Dec 31, 2024 | 3,700,335 | 5.87 | | Granted | 2,305,760 | 17.40 | | Exercised | (7,944) | 0.76 | | Cancelled or forfeited | (24,000) | 10.16 | | **Outstanding as of June 30, 2025** | **5,974,151** | **10.31** | | Exercisable as of June 30, 2025 | 2,097,556 | 6.39 | Stock-Based Compensation Expense (in thousands) | Expense Category | Three Months Ended June 30, 2025 ($) | Three Months Ended June 30, 2024 ($) | Six Months Ended June 30, 2025 ($) | Six Months Ended June 30, 2024 ($) | | :----------------------------- | :----------------------------------- | :----------------------------------- | :----------------------------------- | :----------------------------------- | | Research and development | 1,084 | 396 | 1,888 | 675 | | General and administrative | 1,756 | 575 | 3,046 | 943 | | **Total** | **2,840** | **971** | **4,934** | **1,618** | - Total stock-based compensation expense increased to **$4.9 million** for the six months ended June 30, 2025, from **$1.6 million** in the prior year[66](index=66&type=chunk) [10. Segment Information](index=21&type=section&id=10.%20Segment%20Information) This note provides a breakdown of the company's net loss and expenses by operational categories Segment Net Loss and Expenses (in thousands) | Category | Three Months Ended June 30, 2025 ($) | Three Months Ended June 30, 2024 ($) | Six Months Ended June 30, 2025 ($) | Six Months Ended June 30, 2024 ($) | | :---------------------------------------------------- | :----------------------------------- | :----------------------------------- | :----------------------------------- | :----------------------------------- | | External research and development expenses | 11,291 | 5,485 | 21,269 | 13,204 | | Personnel-related R&D (excl. stock-based comp) | 2,494 | 1,821 | 4,877 | 3,508 | | Facility and IT allocated R&D expenses | 464 | 460 | 904 | 924 | | Personnel-related G&A (excl. stock-based comp) | 2,417 | 1,267 | 4,649 | 2,467 | | General corporate and facility expenses | 1,902 | 876 | 3,845 | 1,971 | | Other segment items | (500) | (1,357) | (994) | (1,675) | | **Net loss** | **18,068** | **8,552** | **34,550** | **20,399** | - External research and development expenses increased significantly, reflecting increased clinical programs and combination development activities[67](index=67&type=chunk) - Personnel-related expenses for both R&D and G&A functions increased due to workforce expansion[67](index=67&type=chunk) [11. Net Loss Per Share](index=22&type=section&id=11.%20Net%20Loss%20Per%20Share) This note explains the calculation of net loss per share and the impact of anti-dilutive securities Shares Excluded from Diluted Net Loss Per Share Calculation | Category | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :----------------------------- | :----------------------------- | :----------------------------- | | Convertible Preferred Stock | — | 27,149,206 | | Options to purchase common stock | 5,974,151 | 3,434,751 | | Unvested restricted common stock | — | 165,301 | | **Total** | **5,974,151** | **30,749,258** | - All convertible preferred stock converted to common stock upon the IPO in 2025, hence no preferred stock was excluded from diluted EPS calculation for the 2025 period[68](index=68&type=chunk) - Options to purchase common stock and unvested restricted common stock were excluded due to their anti-dilutive effect[68](index=68&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=23&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) This section provides management's perspective on financial condition, operations, product candidate progress, liquidity, and future funding needs [Overview](index=23&type=section&id=Overview) This section provides a high-level summary of the company's mission and recent clinical development milestones - Sionna Therapeutics is a clinical-stage biopharmaceutical company developing novel medicines to normalize CFTR protein function for cystic fibrosis patients[71](index=71&type=chunk) - The company announced positive topline data from two Phase 1 clinical trials for lead NBD1 stabilizer product candidates, SION-719 and SION-451, in June 2025[73](index=73&type=chunk) - Both SION-719 and SION-451 were well tolerated, with no serious adverse events, and met exposure thresholds predictive of clinically meaningful benefit in preclinical models[74](index=74&type=chunk) - SION-719 will advance into a Phase 2a proof-of-concept trial in CF patients as an add-on to standard of care, anticipated in H2 2025[75](index=75&type=chunk) - SION-451 will advance to a Phase 1 dual combination trial in healthy volunteers with galicaftor (SION-2222) and SION-109, anticipated in H2 2025[76](index=76&type=chunk) [Strategic In-Licensing & Complementary Modulators](index=24&type=section&id=Strategic%20In-Licensing%20%26%20Complementary%20Modulators) This section describes the company's strategy to expand its product pipeline through in-licensing and complementary modulators - The company in-licensed three clinical-stage compounds from AbbVie Global Enterprises Ltd. in 2024 to expand its portfolio of combination product opportunities[77](index=77&type=chunk) - This includes galicaftor (SION-2222), a complementary modulator targeting CFTR's TMD1, which has completed Phase 2 clinical trials[77](index=77&type=chunk) - A Phase 1 clinical trial for another complementary modulator, SION-109 (targeting CFTR's ICL4 region), was completed in December 2024[77](index=77&type=chunk) [Sources of Liquidity and Financing History](index=24&type=section&id=Sources%20of%20Liquidity%20and%20Financing%20History) This section reviews the company's funding sources, historical capital raises, and future liquidity outlook - Since inception in 2019, the company has not generated revenue and has funded operations primarily through preferred stock sales, raising **$330.4 million**[79](index=79&type=chunk) - In February 2025, the company completed its IPO, raising **$199.6 million** net proceeds from the sale of **12,176,467** common shares[79](index=79&type=chunk) - Net losses were **$34.6 million** and **$20.4 million** for the six months ended June 30, 2025, and 2024, respectively, with an accumulated deficit of **$215.6 million** as of June 30, 2025[80](index=80&type=chunk) - Expenses and operating losses are expected to increase substantially due to advancing clinical development, research, regulatory approvals, manufacturing, intellectual property, personnel, and public company costs[81](index=81&type=chunk) - The company expects to finance operations through equity offerings, debt financings, or strategic arrangements, as it does not have approved products for sale[82](index=82&type=chunk) - As of June 30, 2025, cash, cash equivalents, and marketable securities totaled **$337.3 million**, projected to fund operations into 2028[83](index=83&type=chunk)[85](index=85&type=chunk) [Components of Results of Operations](index=25&type=section&id=Components%20of%20Results%20of%20Operations) This section explains the key revenue and expense categories contributing to the company's financial performance - The company has not generated any revenue to date and does not expect to for several years, if ever, relying on product sales from approved products or collaboration/license agreements in the future[87](index=87&type=chunk) - Research and development expenses include personnel, external costs (CROs, CDMOs, consultants), manufacturing, facility costs, and intellectual property protection[89](index=89&type=chunk)[90](index=90&type=chunk) - R&D expenses are expected to increase substantially as product candidates advance to later stages[91](index=91&type=chunk)[92](index=92&type=chunk) - General and administrative expenses include personnel, legal, professional fees, office, IT, and insurance costs, expected to increase with public company operations and pre-commercial activities[94](index=94&type=chunk)[95](index=95&type=chunk) - Interest income is from cash equivalents and marketable securities, while other income primarily consists of sublease income[97](index=97&type=chunk)[98](index=98&type=chunk)[99](index=99&type=chunk)[100](index=100&type=chunk) [Results of Operations](index=28&type=section&id=Results%20of%20Operations) This section provides a comparative analysis of the company's financial performance over different reporting periods [Comparison of the Three Months Ended June 30, 2025 and 2024](index=28&type=section&id=Comparison%20of%20the%20Three%20Months%20Ended%20June%2030,%202025%20and%202024) This section compares the company's financial performance for the second quarter of 2025 against the same period in 2024 Results of Operations (Three Months Ended June 30, in thousands) | Metric | 2025 ($) | 2024 ($) | Change ($) | | :-------------------------- | :------- | :------- | :--------- | | Research and development | 15,383 | 8,233 | 7,150 | | General and administrative | 6,523 | 3,059 | 3,464 | | **Total operating expenses** | **21,906** | **11,292** | **10,614** | | Loss from operations | (21,906) | (11,292) | (10,614) | | Interest income | 3,667 | 2,566 | 1,101 | | Other income | 171 | 174 | (3) | | **Net loss** | **(18,068)** | **(8,552)** | **(9,516)** | - Net loss increased by **$9.5 million** to **$18.1 million** for Q2 2025, compared to **$8.6 million** for Q2 2024[102](index=102&type=chunk) - Research and development expenses increased by **$7.2 million**, primarily due to increased clinical programs and combination development activities, and a **$1.4 million** increase in personnel-related expenses[103](index=103&type=chunk) - General and administrative expenses increased by **$3.5 million**, driven by a **$2.3 million** increase in personnel-related expenses and a **$1.0 million** increase in professional services fees[104](index=104&type=chunk)[108](index=108&type=chunk) - Interest income increased by **$1.1 million** due to increased investment in debt securities from IPO proceeds[105](index=105&type=chunk) [Comparison of the Six Months Ended June 30, 2025 and 2024](index=29&type=section&id=Comparison%20of%20the%20Six%20Months%20Ended%20June%2030,%202025%20and%202024) This section compares the company's financial performance for the first half of 2025 against the same period in 2024 Results of Operations (Six Months Ended June 30, in thousands) | Metric | 2025 ($) | 2024 ($) | Change ($) | | :-------------------------- | :------- | :------- | :--------- | | Research and development | 29,051 | 18,453 | 10,598 | | General and administrative | 12,514 | 5,986 | 6,528 | | **Total operating expenses** | **41,565** | **24,439** | **17,126** | | Loss from operations | (41,565) | (24,439) | (17,126) | | Interest income | 6,667 | 3,698 | 2,969 | | Other income | 348 | 342 | 6 | | **Net loss** | **(34,550)** | **(20,399)** | **(14,151)** | - Net loss increased by **$14.2 million** to **$34.6 million** for the six months ended June 30, 2025, compared to **$20.4 million** for the same period in 2024[107](index=107&type=chunk) - Research and development expenses increased by **$10.6 million**, primarily due to a **$7.3 million** increase in direct R&D for clinical programs and combination development, and a **$2.6 million** increase in personnel-related expenses[109](index=109&type=chunk)[112](index=112&type=chunk) - General and administrative expenses increased by **$6.5 million**, mainly from a **$4.3 million** increase in personnel-related expenses and a **$2.1 million** increase in professional services fees[110](index=110&type=chunk)[113](index=113&type=chunk) - Interest income increased by **$3.0 million** due to higher investment in debt securities following the IPO[111](index=111&type=chunk) [Liquidity and Capital Resources](index=31&type=section&id=Liquidity%20and%20Capital%20Resources) This section discusses the company's current cash position, cash flow activities, and future funding requirements - As of June 30, 2025, the company had **$337.3 million** in cash, cash equivalents, and marketable securities[116](index=116&type=chunk) - Existing capital is believed to be sufficient to fund operations into 2028, but this is a forward-looking estimate subject to risks[122](index=122&type=chunk) - Net cash used in operating activities was **$34.4 million** for the six months ended June 30, 2025, primarily due to net loss[117](index=117&type=chunk)[118](index=118&type=chunk) - Net cash used in investing activities was **$164.4 million**, mainly from purchases of marketable securities[120](index=120&type=chunk) - Net cash provided by financing activities was **$202.1 million**, primarily from the IPO proceeds[121](index=121&type=chunk) - Future funding requirements depend on clinical trial progress, manufacturing costs, regulatory review, intellectual property, personnel, and commercialization efforts[123](index=123&type=chunk) [Contractual Obligations and Commitments](index=33&type=section&id=Contractual%20Obligations%20and%20Commitments) This section addresses the company's contractual obligations and commitments, noting no material changes - No material changes to contractual obligations and commitments during the six months ended June 30, 2025, as described in the Annual Report[126](index=126&type=chunk) [Critical Accounting Estimates](index=33&type=section&id=Critical%20Accounting%20Estimates) This section discusses the significant judgments and assumptions used in preparing the financial statements - No material changes to critical accounting estimates during the six months ended June 30, 2025, as described in the Annual Report[128](index=128&type=chunk) - The preparation of financial statements requires estimates and assumptions affecting reported amounts, based on historical experience and reasonable factors[127](index=127&type=chunk) [Recent Accounting Pronouncements](index=33&type=section&id=Recent%20Accounting%20Pronouncements) This section refers to disclosures regarding recently issued accounting standards and their potential impact - Information on recently issued accounting pronouncements is disclosed in Note 2, 'Summary of Significant Accounting Policies,' within the consolidated financial statements[129](index=129&type=chunk) [Emerging Growth Company and Smaller Reporting Company Status](index=33&type=section&id=Emerging%20Growth%20Company%20and%20Smaller%20Reporting%20Company%20Status) This section explains the company's status as an emerging growth and smaller reporting company, and associated regulatory benefits - The company qualifies as an 'emerging growth company' and 'smaller reporting company,' allowing it to take advantage of reduced disclosure and governance requirements[130](index=130&type=chunk)[131](index=131&type=chunk) - The company has elected to use the extended transition period for complying with new or revised accounting standards[130](index=130&type=chunk) - Emerging growth company status will be maintained until the earlier of five years post-IPO, **$1.235 billion** in annual gross revenue, becoming a large accelerated filer, or issuing over **$1.0 billion** in non-convertible debt[130](index=130&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=34&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) As a 'smaller reporting company,' Sionna Therapeutics, Inc. is not required to provide quantitative and qualitative disclosures about market risk under Item 305 of Regulation S-K - The company is exempt from providing quantitative and qualitative disclosures about market risk due to its 'smaller reporting company' status[132](index=132&type=chunk) [Item 4. Controls and Procedures](index=34&type=section&id=Item%204.%20Controls%20and%20Procedures) This section details the company's disclosure controls and procedures and internal control over financial reporting, concluding that disclosure controls were effective as of June 30, 2025, with no material changes in internal control - Management concluded that disclosure controls and procedures were effective at the reasonable assurance level as of June 30, 2025[133](index=133&type=chunk) - No material changes in internal control over financial reporting occurred during the six months ended June 30, 2025[134](index=134&type=chunk) [Part II - Other Information](index=35&type=section&id=Part%20II%20-%20Other%20Information) This section provides additional information not covered in the financial statements, including legal, risk factors, and equity sales [Item 1. Legal Proceedings](index=35&type=section&id=Item%201.%20Legal%20Proceedings) This section states that Sionna Therapeutics, Inc. is not currently involved in any material legal proceedings that could significantly impact its financial position, results of operations, or cash flows as of June 30, 2025, and records liabilities for probable and estimable future losses from legal matters - The company is not aware of any material legal proceedings currently pending or threatened as of June 30, 2025[136](index=136&type=chunk) - Liabilities for legal matters are recorded when probable and reasonably estimable[136](index=136&type=chunk) [Item 1A. Risk Factors](index=35&type=section&id=Item%201A.%20Risk%20Factors) This section comprehensively outlines various risks impacting the business, including financial, development, third-party dependence, intellectual property, regulatory, commercial, operational, and stock ownership factors [Risks Related to Our Limited Operating History, Financial Condition and Need for Additional Capital](index=35&type=section&id=Risks%20Related%20to%20Our%20Limited%20Operating%20History,%20Financial%20Condition%20and%20Need%20for%20Additional%20Capital) This section details risks stemming from the company's limited operational history, significant losses, and ongoing need for substantial capital - The company is a clinical-stage biopharmaceutical company with a limited operating history, incurring significant operating losses since inception (**$34.6 million** net loss for H1 2025, **$215.6 million** accumulated deficit as of June 30, 2025)[138](index=138&type=chunk)[139](index=139&type=chunk) - Substantial additional funding is required to develop and commercialize product candidates, with no guarantee of raising capital on acceptable terms, potentially leading to delays or elimination of development programs[146](index=146&type=chunk)[148](index=148&type=chunk) - Raising additional capital may dilute stockholders' ownership, restrict operations, or require relinquishing rights to product candidates[149](index=149&type=chunk)[150](index=150&type=chunk) [Risks Related to the Discovery and Development of Our Product Candidates](index=38&type=section&id=Risks%20Related%20to%20the%20Discovery%20and%20Development%20of%20Our%20Product%20Candidates) This section outlines risks associated with the R&D of product candidates, including clinical trial failures and regulatory hurdles - The company is substantially dependent on the success of its NBD1 stabilizers (SION-719 and SION-451); failure to advance or obtain regulatory approval would materially harm the business[152](index=152&type=chunk)[153](index=153&type=chunk) - Developing combination treatments increases complexity and risk, including potential drug-drug interactions, unforeseen side effects, or clinical trial failures[161](index=161&type=chunk)[162](index=162&type=chunk) - Regulatory approval processes are lengthy, time-consuming, and unpredictable, with no assurance of obtaining approval for any product candidate[164](index=164&type=chunk) - Preclinical, interim, topline, and preliminary results are not necessarily predictive of later clinical trial outcomes, and positive results may not be replicated[179](index=179&type=chunk)[181](index=181&type=chunk)[182](index=182&type=chunk) - Targeting the NBD1 domain of the CFTR protein is novel, introducing uncertainty regarding successful product development and potential regulatory challenges[185](index=185&type=chunk)[186](index=186&type=chunk) - Clinical trials may fail to demonstrate safety and efficacy, or identify serious adverse side effects, potentially leading to abandonment, delays, or limitations on development[187](index=187&type=chunk) [Risks Related to Our Dependence on Third Parties](index=53&type=section&id=Risks%20Related%20to%20Our%20Dependence%20on%20Third%20Parties) This section addresses risks arising from reliance on third parties for intellectual property, clinical trials, manufacturing, and collaborations - The company is dependent on licensed intellectual property from third parties (e.g., Sanofi, AbbVie); loss of these rights or breach of agreements could prevent development or commercialization[219](index=219&type=chunk)[220](index=220&type=chunk) - Reliance on CROs and other vendors for clinical trials means limited control over their performance, potentially leading to delays or compromised data quality[224](index=224&type=chunk)[225](index=225&type=chunk) - Reliance on CDMOs for manufacturing increases the risk of insufficient quantities, unacceptable cost/quality, or supply disruptions, potentially delaying development or commercialization[228](index=228&type=chunk)[229](index=229&type=chunk) - Establishing collaborations for development or commercialization is challenging; failure to secure favorable terms or unsuccessful arrangements could alter development plans[233](index=233&type=chunk)[234](index=234&type=chunk)[235](index=235&type=chunk) [Risks Related to Our Intellectual Property](index=58&type=section&id=Risks%20Related%20to%20Our%20Intellectual%20Property) This section covers risks concerning the company's ability to obtain, maintain, enforce, and protect its intellectual property rights - Inability to obtain, maintain, and enforce intellectual property rights (patents, trade secrets) could allow competitors to commercialize similar products, adversely affecting commercialization efforts[239](index=239&type=chunk)[240](index=240&type=chunk)[241](index=241&type=chunk) - Patent terms may be inadequate to protect competitive position, and failure to obtain patent term extensions could shorten exclusivity and reduce revenue[250](index=250&type=chunk)[251](index=251&type=chunk)[252](index=252&type=chunk) - Failure to comply with obligations in third-party intellectual property licenses could result in loss of material rights, impacting development and commercialization[253](index=253&type=chunk)[255](index=255&type=chunk) - Patent reform legislation (e.g., Leahy-Smith Act) and changes in patent laws could increase uncertainties and costs for patent prosecution and enforcement[260](index=260&type=chunk)[261](index=261&type=chunk)[262](index=262&type=chunk) - Involvement in lawsuits to protect or enforce patents could be expensive, time-consuming, and unsuccessful, potentially leading to invalidation of patents or licensing requirements[263](index=263&type=chunk)[264](index=264&type=chunk)[265](index=265&type=chunk) - Third parties may allege infringement of their intellectual property rights, leading to litigation, substantial damages, or the need to obtain costly licenses[267](index=267&type=chunk)[268](index=268&type=chunk) - Reliance on third parties necessitates sharing trade secrets, increasing the risk of misappropriation or unauthorized disclosure, which could harm competitive position[273](index=273&type=chunk)[275](index=275&type=chunk) - Limited geographical patent protection and varying enforceability of intellectual property rights in different countries could hinder global commercialization efforts[277](index=277&type=chunk)[278](index=278&type=chunk)[279](index=279&type=chunk) [Risks Related to Legal and Regulatory Compliance Matters](index=69&type=section&id=Risks%20Related%20to%20Legal%20and%20Regulatory%20Compliance%20Matters) This section details risks associated with healthcare laws, regulatory oversight, reform initiatives, and potential misconduct - Business operations are subject to extensive healthcare laws (e.g., fraud and abuse laws); non-compliance could lead to substantial penalties, reputational harm, and significant defense costs[303](index=303&type=chunk)[304](index=304&type=chunk)[307](index=307&type=chunk) - Approved products remain subject to ongoing regulatory oversight, including manufacturing, labeling, promotion, and post-marketing requirements; failure to comply could result in restrictions or withdrawal from the market[308](index=308&type=chunk)[309](index=309&type=chunk)[311](index=311&type=chunk) - Healthcare reform initiatives in the U.S. and foreign jurisdictions could adversely impact business, leading to more rigorous coverage criteria, downward pressure on pricing, or other negative consequences[313](index=313&type=chunk)[314](index=314&type=chunk)[318](index=318&type=chunk) - Inadequate funding or disruptions at government agencies (FDA, SEC) could delay product development, regulatory approvals, or normal business functions[344](index=344&type=chunk)[345](index=345&type=chunk) - Misconduct by employees, contractors, or collaborators, including non-compliance with regulatory standards or healthcare laws, could lead to significant penalties and reputational damage[346](index=346&type=chunk)[348](index=348&type=chunk) [Risks Related to the Commercialization of Our Product Candidates](index=72&type=section&id=Risks%20Related%20to%20the%20Commercialization%20of%20Our%20Product%20Candidates) This section addresses risks concerning market competition, product acceptance, reimbursement, market size, and product liability - The company faces substantial competition, particularly from Vertex Pharmaceuticals, which holds significant market share and greater resources in the CF market[321](index=321&type=chunk)[324](index=324&type=chunk) - Even if approved, product candidates may fail to achieve sufficient market acceptance by physicians, patients, and third-party payors, especially against established standard-of-care therapies like Trikafta[326](index=326&type=chunk)[327](index=327&type=chunk) - Commercial success depends significantly on obtaining and maintaining coverage and adequate reimbursement from third-party payors; cost containment trends could adversely affect profitability[329](index=329&type=chunk)[330](index=330&type=chunk) - Estimates of the potential market for product candidates may be smaller than anticipated, limiting revenues and hindering profitability[333](index=333&type=chunk) - Clinical trial and product liability lawsuits could divert resources, incur substantial liabilities, and limit commercialization, with insurance potentially inadequate to cover all costs[334](index=334&type=chunk)[335](index=335&type=chunk) [Risks Related to Our Business Operations, Employee Matters and Managing Our Growth](index=76&type=section&id=Risks%20Related%20to%20Our%20Business%20Operations,%20Employee%20Matters%20and%20Managing%20Our%20Growth) This section covers risks related to personnel retention, managing organizational growth, potential litigation, and business disruptions - Future success depends on retaining key executives and attracting/retaining qualified personnel; loss of key individuals could impede objectives[337](index=337&type=chunk)[338](index=338&type=chunk) - Expected expansion in clinical development, regulatory, and commercial capabilities may lead to difficulties in managing growth, disrupting operations and increasing costs[340](index=340&type=chunk) - The company could be affected by litigation, government investigations, and enforcement actions, leading to significant damages, fines, reputational harm, and diversion of resources[341](index=341&type=chunk)[343](index=343&type=chunk) - Business disruptions (e.g., natural disasters, cybersecurity incidents) affecting operations or those of suppliers/CROs could harm revenue, financial condition, and increase costs[354](index=354&type=chunk) [Risks Related to Ownership of Our Common Stock](index=79&type=section&id=Risks%20Related%20to%20Ownership%20of%20Our%20Common%20Stock) This section addresses risks concerning stock price volatility, potential dilution, corporate governance, and dividend policy - Operating results may fluctuate significantly due to various factors (e.g., clinical trial outcomes, competition, regulatory changes), making future results difficult to predict and potentially causing stock price decline[355](index=355&type=chunk)[356](index=356&type=chunk)[357](index=357&type=chunk) - The trading price of common stock may be highly volatile due to industry-specific and general market factors, leading to potential loss of investment[358](index=358&type=chunk)[359](index=359&type=chunk) - Sales of a substantial number of common stock shares by stockholders (e.g., after lock-up expiry) could significantly drop the market price[366](index=366&type=chunk) - Provisions in corporate charter documents and Delaware law may prevent or frustrate attempts to change management or acquire a controlling interest, potentially lowering stock price[367](index=367&type=chunk)[368](index=368&type=chunk)[369](index=369&type=chunk) - Executive officers, directors, and principal stockholders own a significant percentage of stock, allowing them to exert substantial control over stockholder-approved matters[370](index=370&type=chunk) - The company does not anticipate paying cash dividends in the foreseeable future, making capital appreciation the sole source of gain for stockholders[372](index=372&type=chunk) [General Risk Factors](index=84&type=section&id=General%20Risk%20Factors) This section covers broad risks including cybersecurity, data privacy, compliance, internal controls, tax laws, and global economic conditions - Compromised information technology systems or data, or those of third parties, could lead to regulatory actions, litigation, fines, business disruptions, and reputational harm[375](index=375&type=chunk)[376](index=376&type=chunk)[386](index=386&type=chunk) - The company is subject to stringent and evolving data privacy and security laws (e.g., GDPR, HIPAA); non-compliance could result in investigations, fines, litigation, and operational disruptions[389](index=389&type=chunk)[390](index=390&type=chunk)[392](index=392&type=chunk)[397](index=397&type=chunk) - Compliance with governmental export/import controls, economic sanctions, and anti-corruption laws is required; violations could lead to criminal liability and severe consequences[399](index=399&type=chunk)[400](index=400&type=chunk) - Failure to maintain an effective system of internal controls over financial reporting could impair the ability to produce accurate financial statements, leading to stock price decline and sanctions[401](index=401&type=chunk)[404](index=404&type=chunk) - The company may not be able to utilize a significant portion of its net operating loss (NOL) carryforwards due to limitations under Section 382 of the IRC or future regulatory changes[406](index=406&type=chunk)[407](index=407&type=chunk) - New or changed tax laws (e.g., OBBBA) could materially adversely affect business, cash flows, financial condition, or results of operations[408](index=408&type=chunk)[409](index=409&type=chunk)[410](index=410&type=chunk) - Unstable global economic and geopolitical conditions (e.g., inflation, conflicts, tariffs) could adversely affect business, financial condition, stock price, and ability to raise capital[418](index=418&type=chunk)[419](index=419&type=chunk)[420](index=420&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=92&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) This section reports on the company's initial public offering (IPO) completed on February 6, 2025, detailing the shares issued, net proceeds, and the current use of these funds - On February 6, 2025, the company completed its IPO, issuing and selling **12,176,467** shares of common stock at **$18.00** per share[422](index=422&type=chunk) - The IPO generated aggregate net proceeds of **$199.6 million**, after deducting underwriter discounts, commissions, and other offering expenses[422](index=422&type=chunk) - A significant portion of the net proceeds is held in money market funds, with no material change in the planned use of proceeds[423](index=423&type=chunk) [Item 3. Defaults Upon Senior Securities](index=92&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) This section states that there were no defaults upon senior securities during the reporting period - No defaults upon senior securities were reported[425](index=425&type=chunk) [Item 4. Mine Safety Disclosures](index=92&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to Sionna Therapeutics, Inc - This item is not applicable[426](index=426&type=chunk) [Item 5. Other Information](index=92&type=section&id=Item%205.%20Other%20Information) This section discloses Rule 10b5-1 trading arrangements adopted by the company's executive officers during the three months ended June 30, 2025, specifying plans for common stock sales with expiration dates in 2026 Rule 10b5-1 Trading Arrangements Adopted by Executive Officers (Three Months Ended June 30, 2025) | Name (Title) | Action Taken (Date of Action) | Type of Trading Arrangement | Nature of Trading Arrangement | Expiration Date of Trading Arrangement | Aggregate Number of Securities | | :--------------------------------------- | :---------------------------- | :-------------------------- | :---------------------------- | :------------------------------------- | :----------------------------- | | Michael Cloonan (President and CEO) | Adoption (May 21, 2025) | Rule 10b5-1 trading arrangement | Sale | August 17, 2026 | Up to 200,000 | | Elena Ridloff (CFO and Head of Corporate Development) | Adoption (May 20, 2025) | Rule 10b5-1 trading arrangement | Sale | August 6, 2026 | Up to 85,000 | | Jennifer Fitzpatrick (Chief Legal Officer) | Adoption (June 5, 2025) | Rule 10b5-1 trading arrangement | Sale | September 15, 2026 | Up to 41,000 | [Item 6. Exhibits](index=94&type=section&id=Item%206.%20Exhibits) This section lists the exhibits filed with the Form 10-Q, including corporate charter documents, stock certificates, officer certifications, and Inline XBRL documents - Exhibit 3.1: Fifth Amended and Restated Certificate of Incorporation[430](index=430&type=chunk) - Exhibit 3.2: Amended and Restated Bylaws[430](index=430&type=chunk) - Exhibit 4.1: Specimen Common Stock Certificate[430](index=430&type=chunk) - Exhibit 31.1*: Certification of Principal Executive Officer (Section 302)[430](index=430&type=chunk) - Exhibit 31.2*: Certification of Principal Financial Officer (Section 302)[430](index=430&type=chunk) - Exhibit 32.1*+: Certification of Principal Executive Officer and Principal Financial Officer (Section 906)[430](index=430&type=chunk) - Exhibit 101.INS: Inline XBRL Instance Document[430](index=430&type=chunk) - Exhibit 101.SCH: Inline XBRL Taxonomy Extension Schema With Embedded Linkbase Documents[430](index=430&type=chunk) - Exhibit 104: Cover Page Interactive Data File[430](index=430&type=chunk) [Signatures](index=95&type=section&id=SIGNATURES) This section contains the authorized signatures confirming the submission of the Form 10-Q report [Authorized Signatures](index=95&type=section&id=Authorized%20Signatures) This section contains the authorized signatures for the Form 10-Q report, confirming its submission on behalf of Sionna Therapeutics, Inc. by its President and Chief Executive Officer, Michael Cloonan, and its Chief Financial Officer and Head of Corporate Development, Elena Ridloff, both dated August 11, 2025 - The report is signed by Michael Cloonan, President and Chief Executive Officer (Principal Executive Officer), and Elena Ridloff, Chief Financial Officer and Head of Corporate Development (Principal Financial Officer and Principal Accounting Officer)[436](index=436&type=chunk) - The signing date for the report is August 11, 2025[436](index=436&type=chunk)

PART I—FINANCIAL INFORMATION [Financial Statements](index=4&type=section&id=Item%201.%20Financial%20Statements) Financial statements reflect the company's June 24, 2025, Chapter 11 emergence and fresh start accounting, making Predecessor and Successor periods non-comparable - The company emerged from Chapter 11 bankruptcy on **June 24, 2025**, applying fresh start accounting, which renders Predecessor and Successor financial periods non-comparable due to asset and liability revaluation[29](index=29&type=chunk)[30](index=30&type=chunk)[32](index=32&type=chunk) Consolidated Balance Sheet Highlights (in thousands) | Account | Successor (June 30, 2025) | Predecessor (Dec 28, 2024) | | :--- | :--- | :--- | | **Total Assets** | **$1,033,118** | **$550,276** | | Cash and cash equivalents | $152,379 | $53,024 | | Goodwill | $199,053 | $239,583 | | Other intangible assets, net | $527,566 | $115,762 | | **Total Liabilities** | **$652,149** | **$1,664,648** | | Long-term debt, net | $465,518 | $1,430,643 | | **Total Equity (Deficit)** | **$380,969** | **($1,114,372)** | Consolidated Statement of Operations Highlights (in thousands) | Account | Successor (Jun 25-30, 2025) | Predecessor (Mar 30 - Jun 24, 2025) | Predecessor (Q2 2024) | | :--- | :--- | :--- | :--- | | Revenues, net | $12,167 | $176,997 | $202,073 | | Operating income | $2,586 | $41,404 | $35,933 | | Reorganization items, net | — | ($1,143,918) | — | | Net income | $1,254 | $1,190,688 | $23,269 | [Notes to Unaudited Consolidated Financial Statements](index=12&type=section&id=Notes%20to%20Unaudited%20Consolidated%20Financial%20Statements) Notes detail the Chapter 11 reorganization, including emergence on June 24, 2025, fresh start accounting, debt reduction, and impairment charges, with sufficient post-emergence liquidity - The company filed for Chapter 11 bankruptcy on **May 6, 2025**, emerging on **June 24, 2025**, with the plan discharging prior debt, issuing a new **$465 million** term loan, and reallocating equity (91% to first lien holders, 9% to former equity holders)[29](index=29&type=chunk)[41](index=41&type=chunk)[42](index=42&type=chunk) - Fresh start accounting adoption established a reorganization value of **$1.02 billion** and an enterprise value of **$700 million**, leading to significant adjustments including **$529 million** in new intangible assets, primarily a **$320 million** trade name[45](index=45&type=chunk)[47](index=47&type=chunk)[98](index=98&type=chunk) - The company recorded a **$27.5 million** impairment charge on U.S. indefinite-lived franchise rights in Q1 FY2025 (Predecessor), following a **$258.0 million** charge in Q1 FY2024[109](index=109&type=chunk)[108](index=108&type=chunk)[13](index=13&type=chunk) - Post-emergence, the company changed its fiscal year end to **December 31** from the Saturday closest to December 31[36](index=36&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=44&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the company's Chapter 11 emergence, significant debt reduction, declining Behavioral business offset by Clinical growth, and sufficient post-restructuring liquidity - The Chapter 11 reorganization discharged approximately **$1.62 billion** in prepetition debt, replacing it with a new **$465 million** Senior Secured Term Loan Facility maturing in **2030**[168](index=168&type=chunk)[247](index=247&type=chunk) Combined Key Performance Metrics (Q2 2025 vs. Q2 2024) | Metric | Combined Q2 2025 | Q2 2024 | % Change | | :--- | :--- | :--- | :--- | | **Subscription Revenues** | | | | | Behavioral | $157.3 M | $180.2 M | (12.7%) | | Clinical | $30.6 M | $19.7 M | 55.1% | | **Total** | **$187.9 M** | **$200.0 M** | **(6.1%)** | | **End of Period Subscribers** | | | | | Behavioral | 3,040.5 k | 3,755.5 k | (19.0%) | | Clinical | 126.7 k | 81.0 k | 56.5% | | **Total** | **3,167.2 k** | **3,836.5 k** | **(17.4%)** | - The decline in Behavioral Subscription Revenues resulted from recruitment challenges and a lower subscriber base, while Clinical Subscription Revenues increased due to growth in compounded semaglutide subscriptions[215](index=215&type=chunk)[196](index=196&type=chunk) - Post-emergence, the company held **$152.4 million** in unrestricted cash, believing its liquidity is sufficient for at least the next **12 months** due to reduced debt and interest payments[248](index=248&type=chunk)[249](index=249&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=58&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company's primary market risk is interest rate exposure on its new variable-rate Term Loan Facility, with a hypothetical 1.25% change impacting annual interest expense by **$5.8 million** - The company's market risk exposure primarily relates to interest rate changes on its new variable-rate Term Loan Facility[276](index=276&type=chunk) - A hypothetical **125 basis point (1.25%)** change in interest rates would alter annual interest expense by approximately **$5.8 million**, reflecting reduced risk exposure post-debt restructuring[277](index=277&type=chunk) [Controls and Procedures](index=58&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were effective as of June 30, 2025, with no material changes to internal control over financial reporting during the quarter - As of **June 30, 2025**, the company's principal executive and financial officers concluded that disclosure controls and procedures were effective[278](index=278&type=chunk) - No material changes occurred in internal control over financial reporting during the most recent fiscal quarter[279](index=279&type=chunk) PART II—OTHER INFORMATION [Legal Proceedings](index=59&type=section&id=Item%201.%20Legal%20Proceedings) The company's primary legal proceedings involve its Chapter 11 filing and emergence, with other ordinary course actions not expected to materially impact financials - The main legal proceedings are the Chapter 11 Cases, filed on **May 6, 2025**, and emerged from on **June 24, 2025**[130](index=130&type=chunk)[133](index=133&type=chunk) - Management anticipates no material adverse effect on financials from other ordinary course legal matters[134](index=134&type=chunk) [Risk Factors](index=59&type=section&id=Item%201A.%20Risk%20Factors) Key risks post-bankruptcy include impacts on business relationships, non-comparable financials due to fresh start accounting, ability to service **$465.5 million** debt, and risks from discontinued GLP-1 offerings - Emergence from Chapter 11 poses risks to vendor, member, and employee relationships, impacting the company's ability to execute its business plan[282](index=282&type=chunk) - Post-emergence financial results are not comparable to historical data due to fresh start accounting, and bankruptcy-filed projections should not be relied upon[284](index=284&type=chunk) - The company's ability to service its substantial new debt of **$465.5 million** depends on future performance, potentially affected by competition from weight management medications and other market factors[286](index=286&type=chunk) - The discontinued compounded GLP-1 offering (ended **May 22, 2025**) exposes the company to litigation, regulatory, and reputational risks, with customer transition potentially creating near-term business headwinds[294](index=294&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=63&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company reported no unregistered equity sales during the quarter, except those related to bankruptcy emergence, and no equity repurchases were made - No unregistered sales of equity securities occurred during the quarter, except as previously disclosed regarding the bankruptcy emergence[302](index=302&type=chunk) - The company did not repurchase any of its equity securities during the quarter[303](index=303&type=chunk)

[Q2 2025 Financial & Operational Highlights](index=1&type=section&id=AAON%20Reports%20Second%20Quarter%202025%20Results) Overview of the company's second quarter 2025 financial and operational performance, highlighting key results and strategic responses [Second Quarter 2025 Performance Summary](index=1&type=section&id=Second%20Quarter%202025%20Results) Q2 2025 results fell short of expectations due to ERP implementation issues, impacting sales and profitability, despite strong backlog growth Q2 2025 Key Financial Metrics (Year-over-Year) | Metric | Q2 2025 (USD) | Q2 2024 (USD) | Change | | :--- | :--- | :--- | :--- | | Net Sales | $311.6 million | $313.6 million | -0.6% | | Gross Profit Margin | 26.6% | 36.1% | -950 bps | | GAAP Diluted EPS | $0.19 | $0.62 | -69.4% | | Non-GAAP Adj. Diluted EPS | $0.22 | $0.62 | -64.5% | | Non-GAAP Adj. EBITDA Margin | 14.9% | 26.1% | -1,120 bps | - The primary driver of underperformance was poor operational execution, mainly associated with the implementation of a new ERP system at the Longview, TX facility, which impacted production at both Longview and Tulsa[6](index=6&type=chunk) - Despite operational setbacks, booking trends remain strong for both AAON- and BASX-branded equipment, leading to a significant **71.9% year-over-year increase** in adjusted backlog to **$1.12 billion**, suggesting continued market share gains[7](index=7&type=chunk)[8](index=8&type=chunk) - The company is taking immediate actions to address production issues and expects sequential improvement in the second half of the year, but has revised its full-year 2025 outlook downward due to the challenges[6](index=6&type=chunk)[8](index=8&type=chunk) [Segment Performance](index=2&type=section&id=Segment%20Results) Detailed analysis of financial performance across AAON Oklahoma, AAON Coil Products, and BASX segments [AAON Oklahoma](index=2&type=section&id=AAON%20Oklahoma) AAON Oklahoma segment experienced an **18.0% decrease** in net sales and a **970 basis point** gross margin contraction due to ERP-related coil shortages and supply chain issues AAON Oklahoma Q2 Performance | Metric | Q2 2025 (USD) | Q2 2024 (USD) | Change | | :--- | :--- | :--- | :--- | | Net Sales | $185.1 million | $225.7 million | -18.0% | | Gross Profit | $50.9 million | $83.9 million | -39.3% | | Gross Profit Margin | 27.5% | 37.2% | -970 bps | - The sales decrease was driven by lingering supply chain issues from the refrigerant transition and coil supply shortages from the Longview facility's ERP implementation[10](index=10&type=chunk) - Gross profit margin contraction was primarily caused by suboptimal overhead absorption from lower volumes and **$3.0 million** in costs from the new Memphis plant with minimal offsetting sales[11](index=11&type=chunk) [AAON Coil Products](index=3&type=section&id=AAON%20Coil%20Products) AAON Coil Products saw **86.4% sales growth** driven by BASX products, but ERP implementation caused significant production disruptions and a **1,990 basis point** gross margin contraction AAON Coil Products Q2 Performance | Metric | Q2 2025 (USD) | Q2 2024 (USD) | Change | | :--- | :--- | :--- | :--- | | Net Sales | $58.5 million | $31.4 million | +86.4% | | Gross Profit | $12.9 million | $13.2 million | -2.2% | | Gross Profit Margin | 22.0% | 41.9% | -1,990 bps | - Sales growth was driven by BASX branded products for a large liquid cooling data center, while AAON branded products declined due to disruptions from the new ERP system[13](index=13&type=chunk) - Gross margin contracted significantly to **22.0%** from **41.9%** a year ago, a result of production inefficiencies from the ERP system implementation[14](index=14&type=chunk) [BASX](index=3&type=section&id=BASX) The BASX segment delivered strong results with **20.4% net sales growth** driven by data center demand, maintaining a stable gross profit margin with sequential improvement BASX Q2 Performance | Metric | Q2 2025 (USD) | Q2 2024 (USD) | Change | | :--- | :--- | :--- | :--- | | Net Sales | $68.0 million | $56.5 million | +20.4% | | Gross Profit | $19.0 million | $16.1 million | +18.2% | | Gross Profit Margin | 27.9% | 28.5% | -60 bps | - The primary driver of the year-over-year sales increase was stronger demand for data center equipment[16](index=16&type=chunk) - Gross profit margin showed sequential improvement for the second straight quarter, reflecting continued operational improvements[17](index=17&type=chunk) [Financial Position and Outlook](index=3&type=section&id=Financial%20Position%20and%20Outlook) Overview of the company's balance sheet, cash flow, backlog, and revised full-year 2025 financial guidance [Balance Sheet & Cash Flow](index=3&type=section&id=Balance%20Sheet%20%26%20Cash%20Flow) The company maintained **$1.3 million** in cash, drew **$317.3 million** on its credit facility, and secured a new **$500.0 million** facility to support **$220.0 million** in 2025 capital expenditures - At the end of Q2 2025, the company had cash, cash equivalents and restricted cash of **$1.3 million** and a balance on its revolving credit facility of **$317.3 million**[18](index=18&type=chunk) - A new **$500.0 million** credit facility was closed during the quarter to provide liquidity for growth investments. Capital expenditure plans for 2025 remain unchanged at **$220.0 million**[18](index=18&type=chunk) [Backlog](index=3&type=section&id=Backlog) Total backlog surged **71.9% year-over-year** to **$1.12 billion**, driven by strong demand for both AAON-branded and BASX-branded equipment, indicating significant market share gains Backlog by Brand | Brand | June 30, 2025* (USD) | March 31, 2025 (USD) | June 30, 2024 (USD) | YoY Change | QoQ Change | | :--- | :--- | :--- | :--- | :--- | :--- | | AAON-branded | $494.2 million | $403.9 million | $255.5 million | +93.4% | +22.4% | | BASX-branded* | $623.4 million | $623.0 million | $394.5 million | +58.0% | +0.1% | | **Total** | **$1.12 billion** | **$1.03 billion** | **$650.0 million** | **+71.9%** | **+8.8%** | - The significant growth in AAON-branded equipment backlog, despite weakness in the nonresidential construction market, indicates substantial market share gains[20](index=20&type=chunk) - Demand from data center customers remains exceptionally strong, driving continued backlog growth for BASX-branded equipment[21](index=21&type=chunk) [Full-Year 2025 Outlook](index=4&type=section&id=Full-Year%202025%20Outlook) The company revised its full-year 2025 guidance downwards, anticipating low-teens sales growth and a **28%-29%** gross profit margin, reflecting ongoing operational inefficiencies Updated Full-Year 2025 Outlook | Metric | Q3 2025 | Q4 2025 | FY25 | | :--- | :--- | :--- | :--- | | YoY Sales Growth | Low Single Digits | High Twenties | Low Teens | | Gross Profit Margin | 28.5%-29.5% | 30.0%-31.0% | 28%-29% | | Non-GAAP adj. SG&A % of sales | 17.0%-17.5% | 16.5%-17.0% | 16.5%-17.0% | [Financial Statements and Reconciliations](index=5&type=section&id=Financial%20Statements%20and%20Reconciliations) Presentation of unaudited consolidated financial statements and reconciliations of non-GAAP measures to their GAAP equivalents [Consolidated Financial Statements](index=5&type=section&id=Consolidated%20Financial%20Statements) Unaudited consolidated statements of income, segment results, balance sheets, and cash flows for the three and six months ended June 30, 2025, are presented with comparative 2024 data [Consolidated Statements of Income](index=5&type=section&id=Consolidated%20Statements%20of%20Income) Summary of the company's unaudited consolidated income statement for the three and six months ended June 30, 2025 Consolidated Statements of Income (Unaudited) | | Three Months Ended June 30, (USD) | Six Months Ended June 30, (USD) | | :--- | :--- | :--- | | | **2025** | **2024** | **2025** | **2024** | | Net sales | $311.6 million | $313.6 million | $633.6 million | $575.7 million | | Gross profit | $82.7 million | $113.1 million | $169.1 million | $205.3 million | | Income from operations | $23.6 million | $67.2 million | $58.7 million | $114.2 million | | Net income | $15.5 million | $52.2 million | $44.8 million | $91.2 million | | Diluted EPS | $0.19 | $0.62 | $0.54 | $1.09 | [Segment Net Sales and Profit](index=6&type=section&id=Segment%20Net%20Sales%20and%20Profit) Breakdown of gross profit by segment for the three months ended June 30, 2025 and 2024 Segment Gross Profit (Unaudited) | Segment | Three Months Ended June 30, 2025 (USD) | Three Months Ended June 30, 2024 (USD) | | :--- | :--- | :--- | | AAON Oklahoma | $50.9 million | $83.9 million | | AAON Coil Products | $12.9 million | $13.2 million | | BASX | $19.0 million | $16.1 million | | **Consolidated Gross Profit** | **$82.7 million** | **$113.1 million** | [Consolidated Balance Sheets](index=7&type=section&id=Consolidated%20Balance%20Sheets) Overview of the company's unaudited consolidated balance sheet as of June 30, 2025, and December 31, 2024 Consolidated Balance Sheet Highlights (Unaudited) | | June 30, 2025 (USD) | Dec 31, 2024 (USD) | | :--- | :--- | :--- | | Total current assets | $654.2 million | $488.2 million | | Total assets | $1.40 billion | $1.18 billion | | Total current liabilities | $210.7 million | $174.9 million | | Debt, long-term | $317.3 million | $138.9 million | | Total stockholders' equity | $832.7 million | $824.6 million | | Total liabilities and stockholders' equity | $1.40 billion | $1.18 billion | [Consolidated Statements of Cash Flows](index=8&type=section&id=Consolidated%20Statements%20of%20Cash%20Flows) Summary of the company's unaudited consolidated cash flow statement for the six months ended June 30, 2025 and 2024 Consolidated Cash Flow Highlights (Unaudited) | Six Months Ended June 30, | 2025 (USD) | 2024 (USD) | | :--- | :--- | :--- | | Net cash (used in) provided by operating activities | $(31.0 million) | $127.9 million | | Net cash used in investing activities | $(89.5 million) | $(75.4 million) | | Net cash provided by (used in) financing activities | $115.3 million | $(49.5 million) | | Net (decrease) increase in cash | $(5.2 million) | $3.1 million | [Non-GAAP Financial Measures](index=9&type=section&id=Use%20of%20Non-GAAP%20Financial%20Measures) This section provides reconciliations of non-GAAP financial measures, including Adjusted Net Income, EBITDA, and Adjusted EBITDA, to their GAAP counterparts, primarily adjusting for a one-time incentive fee [Reconciliation of Net Income to Non-GAAP Adjusted Net Income](index=9&type=section&id=Non-GAAP%20Adjusted%20Net%20Income) Reconciliation of GAAP net income to non-GAAP adjusted net income, highlighting adjustments for specific items - Non-GAAP adjusted net income for Q2 2025 was **$17.9 million**, or **$0.22 per diluted share**, after adjusting for a **$3.4 million** incentive fee related to the Memphis plant[37](index=37&type=chunk) Non-GAAP Adjusted Net Income Reconciliation (Q2 2025) | | Amount (USD) | | :--- | :--- | | Net income, a GAAP measure | $15.5 million | | Memphis incentive fee | $3.4 million | | Profit sharing effect | $(0.3 million) | | Tax effect | $(0.7 million) | | **Non-GAAP adjusted net income** | **$17.9 million** | [Reconciliation of Net Income to EBITDA and Adjusted EBITDA](index=9&type=section&id=EBITDA) Reconciliation of GAAP net income to EBITDA and Adjusted EBITDA, detailing adjustments for non-operating items - Adjusted EBITDA for Q2 2025 was **$46.6 million**, resulting in an Adjusted EBITDA margin of **14.9%**, compared to **26.1%** in the prior-year quarter. The adjustment accounts for the Memphis incentive fee[41](index=41&type=chunk) Adjusted EBITDA Reconciliation (Q2 2025) | | Amount (USD) | | :--- | :--- | | Net income, a GAAP measure | $15.5 million | | Depreciation and amortization | $19.9 million | | Interest expense, net | $4.0 million | | Income tax expense | $4.0 million | | **EBITDA, a non-GAAP measure** | **$43.5 million** | | Memphis incentive fee | $3.4 million | | Profit sharing effect | $(0.3 million) | | **Adjusted EBITDA, a non-GAAP measure** | **$46.6 million** | [Reconciliation of SG&A to Non-GAAP Adjusted SG&A](index=10&type=section&id=Non-GAAP%20Adjusted%20Selling%2C%20General%20and%20Administrative%20Expenses) Reconciliation of GAAP SG&A expenses to non-GAAP adjusted SG&A, excluding specific non-recurring items - Non-GAAP adjusted SG&A expenses were **$56.0 million** in Q2 2025, or **18.0% of sales**. This is adjusted from the GAAP SG&A of **$59.1 million** to exclude the Memphis incentive fee and its profit-sharing effect[42](index=42&type=chunk)

[Overview and Business Update](index=1&type=section&id=Roivant%20Reports%20Financial%20Results%20for%20the%20First%20Quarter%20Ended%20June%2030%2C%202025%2C%20and%20Provides%20Business%20Update) Roivant reported strong financial results for Q1 2025, highlighted by significant clinical advancements and strategic share repurchases [Key Highlights](index=1&type=section&id=Key%20Highlights) Roivant achieved significant clinical progress, completed a **$1.5 billion** share repurchase, and maintains a strong **$4.5 billion** cash position - The Phase 3 VALOR study of brepocitinib in dermatomyositis (DM) is on track for a topline data readout in **H2 CY2025**[3](index=3&type=chunk) - Two potentially registrational studies for IMVT-1402 in Graves' disease (GD) and Sjögren's disease (SjD) were initiated in **June 2025**[3](index=3&type=chunk) - A **$1.5 billion** share repurchase program was completed, with **$208 million** bought back in the quarter, and a new **$500 million** program approved[3](index=3&type=chunk) - Consolidated cash, cash equivalents, restricted cash, and marketable securities totaled **$4.5 billion** as of **June 30, 2025**[3](index=3&type=chunk) [Major Upcoming Milestones](index=2&type=section&id=Major%20Upcoming%20Milestones) The company anticipates key clinical trial readouts for brepocitinib, batoclimab, and IMVT-1402, alongside progress in Genevant's LNP litigation Key Clinical Trial Readout Timeline | Subsidiary | Drug | Indication | Event | Expected Timing | | :--- | :--- | :--- | :--- | :--- | | Priovant | brepocitinib | Dermatomyositis (DM) | Phase 3 Topline Data | H2 CY2025 | | Priovant | brepocitinib | Non-infectious Uveitis (NIU) | Phase 3 Topline Data | H1 CY2027 | | Priovant | brepocitinib | Cutaneous Sarcoidosis (CS) | Phase 2 Topline Data | H2 CY2026 | | Immunovant | batoclimab | Graves' Disease (GD) | Remission Data | Sep 2025 | | Immunovant | Thyroid Eye Disease (TED) | Phase 3 Data | H2 CY2025 | | Immunovant | IMVT-1402 | Multiple Indications | Topline Results | CY2026 - CY2027 | | Pulmovant | mosliciguat | PH-ILD | Phase 2 Topline Data | H2 CY2026 | - Genevant's LNP litigation against Moderna has a jury trial scheduled for **March 2026**, with a judge's decision pending in the Pfizer/BioNTech case[6](index=6&type=chunk) [Financial Results for the First Quarter Ended June 30, 2025](index=3&type=section&id=First%20Quarter%20Ended%20June%2030%2C%202025%20Financial%20Summary) Roivant reported increased R&D and G&A expenses, leading to a significant loss from continuing operations for the quarter [Financial Summary Narrative](index=3&type=section&id=Financial%20Summary%20Narrative) Roivant's R&D and G&A expenses significantly increased year-over-year, resulting in a **$273.9 million** loss from continuing operations - Consolidated cash, cash equivalents, restricted cash, and marketable securities totaled approximately **$4.5 billion** as of **June 30, 2025**[7](index=7&type=chunk) Year-over-Year Expense Comparison (Three Months Ended June 30) | Expense Category | 2025 | 2024 | Change | | :--- | :--- | :--- | :--- | | R&D Expenses | $152.9M | $120.5M | +$32.4M | | G&A Expenses | $134.0M | $99.9M | +$34.1M | - The increase in R&D costs was primarily driven by program-specific costs for the anti-FcRn franchise (up **$15.2 million**), mosliciguat (up **$5.4 million**), and brepocitinib (up **$4.4 million**)[9](index=9&type=chunk) - Loss from continuing operations was **$273.9 million**, or **$0.33 per share**, for the quarter ended **June 30, 2025**[14](index=14&type=chunk) - Non-GAAP loss from continuing operations was **$170.1 million**, compared to **$107.1 million** for the same period in **2024**[15](index=15&type=chunk) [Selected Balance Sheet Data](index=4&type=section&id=Selected%20Balance%20Sheet%20Data) Roivant's balance sheet as of **June 30, 2025**, shows **$5.03 billion** in total assets and **$4.82 billion** in shareholders' equity, with shifts in cash and marketable securities Selected Balance Sheet Data (in thousands) | Account | June 30, 2025 | March 31, 2025 | | :--- | :--- | :--- | | Cash, cash equivalents and restricted cash | $1,248,609 | $2,725,661 | | Marketable securities | $3,264,692 | $2,171,480 | | Total assets | $5,032,602 | $5,436,940 | | Total liabilities | $216,696 | $249,742 | | Total shareholders' equity | $4,815,906 | $5,187,198 | [Condensed Consolidated Statements of Operations](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) Roivant reported a **$223.4 million** net loss for the quarter ended **June 30, 2025**, a significant decline from the prior year's net income due to increased expenses Condensed Consolidated Statements of Operations (unaudited, in thousands, except per share amounts) | Metric | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | | :--- | :--- | :--- | | Revenue | $2,170 | $7,990 | | Total operating expenses | $287,092 | $220,612 | | Loss from operations | $(284,922) | $(102,235) | | Loss from continuing operations, net of tax | $(273,911) | $(31,603) | | Net (loss) income attributable to Roivant | $(223,355) | $95,297 | | Net (loss) income per common share, basic | $(0.33) | $0.13 | [Reconciliation of GAAP to Non-GAAP Financial Measures](index=6&type=section&id=Reconciliation%20of%20GAAP%20to%20Non-GAAP%20Financial%20Measures) Roivant's non-GAAP loss from continuing operations was **$170.1 million**, adjusted primarily for share-based compensation and changes in investment fair value GAAP to Non-GAAP Reconciliation Summary (in thousands) | Metric | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | | :--- | :--- | :--- | | **Loss from continuing operations, net of tax (GAAP)** | **$(273,911)** | **$(31,603)** | | Share-based compensation | $82,178 | $47,373 | | Gain on sale of Telavant net assets | — | $(110,387) | | Change in fair value of investments | $19,125 | $(15,226) | | Other Adjustments | $2,485 | $2,739 | | **Adjusted loss from continuing operations (Non-GAAP)** | **$(170,124)** | **$(107,112)** | [Corporate Information](index=7&type=section&id=Corporate%20Information) This section provides details on investor communications, Roivant's business model, and standard forward-looking statement disclaimers [Investor Conference Call Information](index=7&type=section&id=Investor%20Conference%20Call%20Information) Roivant will host a conference call and webcast on **August 11, 2025**, to discuss Q1 financial results and provide a corporate update - A conference call and webcast will be held at **8:00 a.m. ET** on **Monday, August 11, 2025**, to discuss the financial results and business update[27](index=27&type=chunk) [About Roivant](index=8&type=section&id=About%20Roivant) Roivant is a biopharmaceutical company developing medicines through its "Vants" subsidiary model, focusing on key pipeline assets for inflammatory and autoimmune diseases - Roivant's key pipeline assets include brepocitinib (TYK2/JAK1 inhibitor), IMVT-1402 and batoclimab (FcRn targeting antibodies), and mosliciguat (sGC activator)[29](index=29&type=chunk) - The company utilizes a subsidiary model, creating "Vants" to develop and commercialize its medicines and technologies[29](index=29&type=chunk) [Forward-Looking Statements](index=8&type=section&id=Roivant%20Forward-Looking%20Statements) This section contains forward-looking statements regarding clinical potential and future results, subject to risks and uncertainties, with no obligation for updates - The press release includes forward-looking statements regarding the clinical and therapeutic potential of product candidates, trial results, and commercial potential[31](index=31&type=chunk) - These statements are covered by the safe harbor provisions of the Securities Act and Exchange Act but are subject to significant risks and uncertainties[30](index=30&type=chunk)[32](index=32&type=chunk)

[PART I. FINANCIAL INFORMATION](index=7&type=section&id=PART%20I.%20FINANCIAL%20INFORMATION) The financial information section details the company's unaudited financial statements, management's analysis of operations and liquidity, market risk exposures, and internal controls [Item 1. Financial Statements (Unaudited)](index=7&type=section&id=Item%201.%20Financial%20Statements%20(Unaudited)) The unaudited condensed consolidated financial statements for the six months ended June 30, 2025, show a significant increase in net loss to $142.2 million from $90.6 million in the prior year period, driven by higher research and development expenses. The balance sheet strengthened, with cash, cash equivalents, and marketable securities totaling $963.1 million. The company's financial position was bolstered by a follow-on public offering in June 2025 and a new collaboration agreement with Gilead [Condensed Consolidated Balance Sheets](index=7&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) This section presents the company's financial position, detailing assets, liabilities, and stockholders' equity as of June 30, 2025, and December 31, 2024 Condensed Consolidated Balance Sheet Highlights (in thousands) | Account | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $335,816 | $120,256 | | Marketable securities (current & non-current) | $627,258 | $730,647 | | Total current assets | $728,327 | $510,268 | | Total assets | $1,131,068 | $978,035 | | **Liabilities & Stockholders' Equity** | | | | Total current liabilities | $87,540 | $67,767 | | Total liabilities | $159,588 | $142,416 | | Accumulated deficit | $(896,805) | $(754,610) | | Total stockholders' equity | $971,480 | $835,619 | - Cash, cash equivalents, and marketable securities totaled **$963.1 million** as of June 30, 2025, which the company believes is sufficient to fund operations and capital expenditures for at least the next twelve months[31](index=31&type=chunk) [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=8&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) This section details the company's revenues, expenses, and net loss for the three and six months ended June 30, 2025, and 2024 Statement of Operations Summary (in thousands, except per share data) | Metric | Q2 2025 | Q2 2024 | H1 2025 | H1 2024 | | :--- | :--- | :--- | :--- | :--- | | Collaboration revenue | $11,476 | $25,650 | $33,576 | $35,937 | | Research and development | $78,388 | $59,202 | $158,643 | $108,021 | | General and administrative | $17,645 | $17,373 | $33,916 | $31,747 | | Loss from operations | $(84,557) | $(50,925) | $(158,983) | $(108,756) | | Net loss | $(76,614) | $(42,062) | $(142,195) | $(90,619) | | Net loss per share | $(0.95) | $(0.58) | $(1.77) | $(1.26) | [Condensed Consolidated Statements of Cash Flows](index=11&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) This section outlines the 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) | Activity | 2025 | 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | $(139,034) | $(82,527) | | Net cash provided by (used in) investing activities | $108,636 | $(314,965) | | Net cash provided by financing activities | $245,984 | $355,168 | | **Net increase (decrease) in cash** | **$215,586** | **$(42,324)** | - Financing activities in H1 2025 were primarily driven by **$237.3 million** in net proceeds from the June 2025 public offering. H1 2024 financing included **$301.4 million** from a January 2024 offering and **$48.7 million** from at-the-market sales[27](index=27&type=chunk) [Notes to Unaudited Condensed Consolidated Financial Statements](index=13&type=section&id=Notes%20to%20Unaudited%20Condensed%20Consolidated%20Financial%20Statements) The notes detail significant accounting policies, financing activities, and collaboration agreements. Key events include a new collaboration with Gilead in June 2025 providing a $40 million upfront payment, and an update on the Sanofi collaboration where Sanofi will advance a next-generation IRAK4 degrader (KT-485) and stop development of KT-474. The company also completed a follow-on public offering in June 2025, raising approximately $250.8 million in gross proceeds before the underwriters' option exercise - In June 2025, the company entered into an exclusive option and license agreement with Gilead to develop CDK2 degraders, receiving a **$40.0 million** non-refundable upfront payment. The company is eligible for an additional **$45.0 million** upon option exercise and up to **$665.0 million** in milestones, plus tiered royalties[52](index=52&type=chunk)[55](index=55&type=chunk) - In June 2025, Sanofi exercised its full participation election to advance the next-generation IRAK4 degrader, KT-485/SAR447971, into clinical testing and intends to stop the development of KT-474. Kymera remains eligible for up to **$975 million** in future milestones[71](index=71&type=chunk) - On June 30, 2025, the company completed a follow-on public offering, raising aggregate gross proceeds of approximately **$250.8 million** before deducting expenses. The underwriters' full option exercise in July 2025 added another **$37.6 million** in gross proceeds[35](index=35&type=chunk)[138](index=138&type=chunk) - In February 2024, the company occupied its new facility and exited its 2019 lease, resulting in an impairment charge of **$4.9 million** in the first quarter of 2024[100](index=100&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=39&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the company's focus on targeted protein degradation (TPD) in immunology, highlighting progress in its STAT6, IRF5, and IRAK4 programs. The analysis of financial results shows a significant year-over-year increase in R&D expenses, primarily due to advancing the STAT6 program. Despite a wider net loss, the company reports a strong liquidity position with a cash runway extending into the second half of 2028, supported by recent financing and collaboration payments [Overview](index=39&type=section&id=Overview) This section provides an overview of the company's strategic focus on targeted protein degradation in immunology and its financial position - The company is a clinical-stage biopharmaceutical firm focused on targeted protein degradation (TPD), primarily for high-value targets in immunology, including STAT6, IRF5, and IRAK4[144](index=144&type=chunk)[146](index=146&type=chunk) - In May 2025, the company made a strategic decision to not advance its TYK2 degrader, KT-295, into clinical development to reallocate resources and extend its cash runway[146](index=146&type=chunk) - As of June 30, 2025, the company had **$963.1 million** in cash, cash equivalents, and marketable securities. Management believes this, plus subsequent proceeds, is sufficient to fund operations into the second half of 2028[153](index=153&type=chunk)[210](index=210&type=chunk) [Results of Operations](index=48&type=section&id=Results%20of%20Operations) This section analyzes the company's financial performance, detailing changes in collaboration revenue, research and development expenses, and net loss for the reported periods Comparison of Results for the Three Months Ended June 30 (in thousands) | Account | 2025 | 2024 | Change | | :--- | :--- | :--- | :--- | | Collaboration revenue | $11,476 | $25,650 | $(14,174) | | Research and development | $78,388 | $59,202 | $19,186 | | Net loss | $(76,614) | $(42,062) | $(34,552) | Comparison of Results for the Six Months Ended June 30 (in thousands) | Account | 2025 | 2024 | Change | | :--- | :--- | :--- | :--- | | Collaboration revenue | $33,576 | $35,937 | $(2,361) | | Research and development | $158,643 | $108,021 | $50,622 | | Net loss | $(142,195) | $(90,619) | $(51,576) | - The **$50.6 million** increase in R&D expenses for H1 2025 was primarily driven by a **$27.2 million** increase in costs for the STAT6 program, a **$14.8 million** increase in personnel and internal costs, and increased spending on the TYK2 and discovery programs[194](index=194&type=chunk) [Liquidity and Capital Resources](index=53&type=section&id=Liquidity%20and%20Capital%20Resources) This section assesses the company's ability to meet its short-term and long-term financial obligations, focusing on cash position and cash flow activities - The company had cash, cash equivalents, and marketable securities of **$963.1 million** as of June 30, 2025[198](index=198&type=chunk) - Net cash used in operating activities increased to **$139.0 million** for the first six months of 2025, compared to **$82.5 million** for the same period in 2024, primarily due to a higher net loss[201](index=201&type=chunk)[202](index=202&type=chunk) - Net cash provided by financing activities was **$246.0 million** for the first six months of 2025, mainly from a public offering, compared to **$355.2 million** in the prior year period which included proceeds from an offering and at-the-market sales[201](index=201&type=chunk)[206](index=206&type=chunk)[207](index=207&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=57&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company's primary market risk exposure is to interest rate changes affecting its cash equivalents and marketable securities, though the impact of a 10% change is not expected to be material. It also has minor exposure to foreign currency exchange rates and notes the potential impact of inflation on operating costs, which is partially offset by higher interest income - The company's main market risk is interest rate sensitivity on its cash and investments, but due to the short-term nature of its portfolio, a **10%** change in rates is not expected to have a material impact[218](index=218&type=chunk) - The company is exposed to inflation, which increases labor, vendor, and clinical trial costs, but notes that higher interest rates have also resulted in higher interest income[220](index=220&type=chunk) [Item 4. Controls and Procedures](index=57&type=section&id=Item%204.%20Controls%20and%20Procedures) Management, including the CEO and CFO, evaluated the company's disclosure controls and procedures as of June 30, 2025, and concluded they were effective at a reasonable assurance level. There were no material changes in internal control over financial reporting during the quarter - Management concluded that the company's disclosure controls and procedures were effective as of June 30, 2025[222](index=222&type=chunk) - No material changes to the company's internal control over financial reporting occurred during the quarter[223](index=223&type=chunk) [PART II. OTHER INFORMATION](index=58&type=section&id=PART%20II.%20OTHER%20INFORMATION) This section covers legal proceedings, comprehensive risk factors, unregistered equity sales, other significant information, and a list of exhibits filed with the report [Item 1. Legal Proceedings](index=58&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently a party to any legal proceedings that are expected to have a material adverse effect on its business - As of the report date, the company is not involved in any litigation or legal proceedings that management believes would likely have a material adverse effect on the business[226](index=226&type=chunk) [Item 1A. Risk Factors](index=58&type=section&id=Item%201A.%20Risk%20Factors) The company outlines numerous risks to its business, emphasizing its clinical-stage status, history of significant operating losses, and dependence on raising additional capital. Key risks include the unproven nature of its targeted protein degradation (TPD) approach, potential for clinical trial delays or failures, reliance on third-party collaborators and manufacturers, and the need to obtain and defend intellectual property. It also highlights risks related to competition, commercialization, regulatory approval, and market volatility - The company is a clinical-stage entity with a history of significant operating losses (**$896.8 million** accumulated deficit as of June 30, 2025) and expects to incur continued losses for the foreseeable future[228](index=228&type=chunk)[229](index=229&type=chunk) - The company's drug discovery approach, targeted protein degradation (TPD), is novel and unproven, making it difficult to predict the time, cost, and likelihood of successfully developing any products[247](index=247&type=chunk) - The business is heavily dependent on third parties for conducting clinical trials (CROs), manufacturing products (CMOs), and advancing certain programs through collaborations (e.g., Sanofi and Gilead)[345](index=345&type=chunk)[356](index=356&type=chunk) - The company faces substantial competition from other firms developing protein degraders and traditional therapies, many of which have greater financial and technical resources[336](index=336&type=chunk)[337](index=337&type=chunk)[338](index=338&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=145&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company reports no sales of unregistered equity securities during the quarter ended June 30, 2025 - There were no sales of unregistered securities during the three months ended June 30, 2025[466](index=466&type=chunk) [Item 5. Other Information](index=145&type=section&id=Item%205.%20Other%20Information) The company discloses that Jared Gollob, Chief Medical Officer, adopted a Rule 10b5-1 trading plan on June 2, 2025, for the potential sale of up to 111,997 shares of common stock through December 31, 2026 - On June 2, 2025, Chief Medical Officer Jared Gollob adopted a Rule 10b5-1 trading plan covering the exercise of vested stock options and sale of up to **111,997** shares of common stock[468](index=468&type=chunk) [Item 6. Exhibits](index=146&type=section&id=Item%206.%20Exhibits) This section lists the exhibits filed with the Form 10-Q, including the form of Pre-Funded Warrant, a Registration Rights Agreement, a letter agreement with Genzyme, the amended director compensation policy, and officer certifications

Exhibit 99.1 Immunovant Provides Corporate Updates and Reports Financial Results for the Quarter Ended June 30, 2025 NEW YORK, August 11, 2025 – Immunovant, Inc. (Nasdaq: IMVT), a clinical-stage immunology company dedicated to enabling normal lives for people with autoimmune diseases, today reported corporate updates and financial results for the quarter ended June 30, 2025. Recent Highlights and Upcoming Milestones: In June 2025, Immunovant initiated a second potentially registrational trial evaluating IMV ...

[Executive Summary](index=1&type=section&id=Executive%20Summary) [Key Highlights](index=1&type=section&id=Key%20Highlights) Sionna Therapeutics reported positive Phase 1 data for NBD1 stabilizers, is advancing to Phase 2a and dual combination trials in H2 2025, and holds $337.3 million in cash to fund operations into 2028 - Positive Phase 1 data for SION-719 and SION-451 demonstrated both **NBD1 stabilizers were generally well tolerated and exceeded pharmacokinetic targets**[1](index=1&type=chunk) - Initiation of Phase 2a proof-of-concept trial of SION-719 and advancement of Phase 1 healthy volunteer trial of SION-451 in two proprietary dual combinations are **on track for the second half of 2025, with topline data expected in mid-2026**[1](index=1&type=chunk) Cash Position and Funding Outlook | Metric | Amount (Millions) | | :----- | :---------------- | | Cash, cash equivalents, and marketable securities (as of June 30, 2025) | $337.3 | | Expected to fund operations | Into 2028 | [Business Update](index=1&type=section&id=Business%20Update) [CEO Commentary](index=1&type=section&id=CEO%20Commentary) CEO Mike Cloonan expressed satisfaction with positive Phase 1 data for SION-719 and SION-451, reinforcing confidence in advancing NBD1 stabilizers to Phase 2a and dual combination trials this year with mid-2026 topline results - CEO Mike Cloonan expressed pleasure with progress, citing **encouraging tolerability and PK data from Phase 1 trials of SION-719 and SION-451**[2](index=2&type=chunk) - Confidence in advancing both NBD1 stabilizers into next development stages, with **Phase 2a SION-719 and Phase 1 SION-451 dual combination trials planned for initiation this year and topline results in mid-2026**[2](index=2&type=chunk) [Pipeline Updates](index=1&type=section&id=Pipeline%20Updates) Sionna provided updates on NBD1 stabilizers SION-719 and SION-451, including positive Phase 1 results, plans for Phase 2a and Phase 1 dual combination trials, and preclinical data showing full F508del-CFTR correction with dual combinations [NBD1 Stabilizers (SION-719 & SION-451)](index=1&type=section&id=NBD1%20Stabilizers%20(SION-719%20%26%20SION-451)) Positive Phase 1 results for SION-719 and SION-451, announced in June 2025, demonstrated general tolerability and exceeded target exposure levels in healthy volunteers, suggesting potential for clinically meaningful benefit as add-on or dual combination therapies - Positive Phase 1 data for SION-719 and SION-451 announced in June 2025, demonstrating **general tolerability and exceeding target exposure levels in over 200 healthy volunteers**[3](index=3&type=chunk) - Data reinforces Sionna's decision to progress SION-719 and SION-451, believing they have the **potential for clinically meaningful benefit as add-on therapies or in proprietary dual combinations**[3](index=3&type=chunk) [Phase 2a Proof-of-Concept Trial with SION-719](index=1&type=section&id=Phase%202a%20Proof-of-Concept%20Trial%20with%20SION-719) Sionna is on track to initiate a Phase 2a proof-of-concept trial for SION-719 in H2 2025, with topline data anticipated in mid-2026, following completion of a midazolam drug-drug interaction study - Phase 2a proof-of-concept trial for SION-719 as an add-on to standard of care in CF patients is **on track for H2 2025, with topline data expected in mid-2026**[3](index=3&type=chunk) - The trial aims to demonstrate the **unique mechanism of NBD1 stabilization and potential to improve CFTR function beyond current SOC**, as defined by sweat chloride[3](index=3&type=chunk) - Midazolam drug-drug interaction study for SION-719 initiated and **on track for completion prior to Phase 2a trial**[4](index=4&type=chunk) [Phase 1 Dual Combination Trial with SION-451 and Complementary Modulators](index=2&type=section&id=Phase%201%20Dual%20Combination%20Trial%20with%20SION-451%20and%20Complementary%20Modulators) Sionna plans to advance a Phase 1 healthy volunteer trial for SION-451 in dual combination with SION-2222 and SION-109 in H2 2025, with topline data expected in mid-2026 - Phase 1 healthy volunteer trial evaluating SION-451 in combination with SION-2222 (TMD1-directed CFTR corrector) and SION-109 (ICL4-directed CFTR corrector) is **on track for H2 2025**[9](index=9&type=chunk) - Topline data from the SION-451 dual combination trial is **anticipated in mid-2026**[9](index=9&type=chunk) [Preclinical Data Presented at 48th European Cystic Fibrosis Conference](index=2&type=section&id=Preclinical%20Data%20Presented%20at%2048th%20European%20Cystic%20Fibrosis%20Conference) Sionna presented preclinical data at the 48th ECFS Annual Conference in June 2025, demonstrating full correction of F508del-CFTR in CF models using NBD1 stabilizers in dual combinations with complementary modulators - Preclinical data presented at 48th ECFS Annual Conference in June 2025 demonstrated **full correction of F508del-CFTR in CF models using Sionna's NBD1 stabilizers in dual combinations with proprietary complementary modulators**[9](index=9&type=chunk) - These findings highlight the **strong mechanistic rationale and synergy of Sionna's dual combination approach to restoring CFTR function**[9](index=9&type=chunk) [Financial Results](index=2&type=section&id=Financial%20Results) [Second Quarter 2025 Financial Performance](index=2&type=section&id=Financial%20Results%20for%20the%20Quarter%20Ended%20June%2030,%202025) Sionna Therapeutics reported increased Q2 2025 operating expenses, driven by higher R&D and G&A costs, resulting in a widened net loss of $18.1 million compared to $8.6 million in Q2 2024 [Research and Development Expenses](index=2&type=section&id=Research%20and%20Development%20Expenses) Research and development expenses significantly increased to $15.4 million in Q2 2025 from $8.2 million in Q2 2024, primarily due to direct program spend supporting Sionna's clinical pipeline Research and Development Expenses (QoQ) | Period | 2025 Q2 (in thousands) | 2024 Q2 (in thousands) | Change (YoY) | | :----- | :--------------------- | :--------------------- | :----------- | | R&D Expenses | $15,383 | $8,233 | +86.8% | - Increase mainly driven by **direct program spend to support Sionna's clinical pipeline**[5](index=5&type=chunk) [General and Administrative Expenses](index=2&type=section&id=General%20and%20Administrative%20Expenses) General and administrative expenses rose to $6.5 million in Q2 2025 from $3.1 million in Q2 2024, primarily due to personnel-related costs and professional fees General and Administrative Expenses (QoQ) | Period | 2025 Q2 (in thousands) | 2024 Q2 (in thousands) | Change (YoY) | | :----- | :--------------------- | :--------------------- | :----------- | | G&A Expenses | $6,523 | $3,059 | +113.2% | - Increase primarily due to **personnel-related costs, including stock-based compensation, and professional fees**[6](index=6&type=chunk) [Net Loss](index=2&type=section&id=Net%20Loss) The net loss for Q2 2025 was $18.1 million, significantly higher than the $8.6 million net loss in Q2 2024, reflecting increased operating expenses Net Loss (QoQ) | Period | 2025 Q2 (in thousands) | 2024 Q2 (in thousands) | Change (YoY) | | :----- | :--------------------- | :--------------------- | :----------- | | Net Loss | $(18,068) | $(8,552) | +111.3% | [Cash Position and Outlook](index=2&type=section&id=Cash%20and%20Cash%20Equivalents) As of June 30, 2025, Sionna held $337.3 million in cash, cash equivalents, and marketable securities, anticipated to fund operations into 2028 Cash Position and Funding Outlook | Metric | Amount (Millions) | Funding Outlook | | :----- | :---------------- | :-------------- | | Cash, cash equivalents, and marketable securities (as of June 30, 2025) | $337.3 | Into 2028 | [Company Overview](index=2&type=section&id=Company%20Overview) [About Sionna Therapeutics](index=2&type=section&id=About%20Sionna%20Therapeutics_detail) Sionna Therapeutics is a clinical-stage biopharmaceutical company focused on revolutionizing cystic fibrosis treatment by developing novel medicines that normalize CFTR protein function through NBD1 stabilization and complementary modulators - Sionna Therapeutics is a clinical-stage biopharmaceutical company focused on **normalizing CFTR protein function to revolutionize cystic fibrosis treatment**[8](index=8&type=chunk) - The company's goal is to **restore CFTR function by directly stabilizing its NBD1 domain and developing complementary CFTR modulators to work synergistically**[8](index=8&type=chunk) - Leveraging over a decade of NBD1 research, Sionna is **advancing small molecules engineered to correct defects caused by the F508del genetic mutation**[8](index=8&type=chunk) [Additional Information](index=2&type=section&id=Additional%20Information) [Investor Relations and Disclosure](index=2&type=section&id=Investor%20Relations%20and%20Disclosure) Sionna intends to use its Investor Relations website for disclosing material nonpublic information and fulfilling Regulation FD obligations, advising investors to monitor it alongside other public communications - Sionna intends to use its **Investor Relations website for disclosing material nonpublic information and complying with Regulation FD**[9](index=9&type=chunk)[10](index=10&type=chunk) - Investors should **monitor the Investor Relations website in addition to press releases, SEC filings, public conference calls, presentations, and webcasts**[10](index=10&type=chunk) [Cautionary Note Regarding Forward-Looking Statements](index=3&type=section&id=Cautionary%20Note%20Regarding%20Forward-Looking%20Statements) This section highlights forward-looking statements subject to risks and uncertainties regarding clinical trial timing, results, safety, efficacy, and financial projections, advising that actual results may differ materially and disclaiming any obligation to update these statements except as required by law - The press release contains **forward-looking statements regarding Sionna's goals, R&D programs, clinical trials (initiation, timing, results), product candidate safety/efficacy, preclinical study predictability, and financial projections**[11](index=11&type=chunk) - These statements are subject to **risks and uncertainties inherent in product development, regulatory developments, and economic conditions, which may cause actual results to differ materially**[11](index=11&type=chunk) - Sionna explicitly **disclaims any obligation to update forward-looking statements except as required by law**[11](index=11&type=chunk) [Media and Investor Contacts](index=3&type=section&id=Media%20Contact) Contact information for media inquiries (Adam Daley, CG Life) and investor relations (Juliet Labadorf) is provided - Media contact: **Adam Daley, CG Life (adaley@cglife.com, 212.253.8881)**[12](index=12&type=chunk) - Investor contact: **Juliet Labadorf (ir@sionnatx.com)**[12](index=12&type=chunk) [Consolidated Financial Statements](index=4&type=section&id=Consolidated%20Financial%20Statements) [Consolidated Statements of Operations](index=4&type=section&id=Consolidated%20Statements%20of%20Operations) The Consolidated Statements of Operations show a significant increase in operating expenses and net loss for both the three and six months ended June 30, 2025, compared to 2024, primarily driven by research and development and general and administrative expenses Consolidated Statements of Operations (Selected Data, in thousands) | Metric | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :---------------------------------- | :------------------------------- | :------------------------------- | :------------------------------- | :------------------------------- | | Research and development | $15,383 | $8,233 | $29,051 | $18,453 | | General and administrative | $6,523 | $3,059 | $12,514 | $5,986 | | Total operating expenses | $21,906 | $11,292 | $41,565 | $24,439 | | Loss from operations | $(21,906) | $(11,292) | $(41,565) | $(24,439) | | Interest income | $3,667 | $2,566 | $6,667 | $3,698 | | Net loss | $(18,068) | $(8,552) | $(34,550) | $(20,399) | | Net loss per share, basic and diluted | $(0.41) | $(2.71) | $(0.98) | $(6.54) | | Weighted-average common shares outstanding | 44,116,997 | 3,159,815 | 35,404,928 | 3,121,225 | [Selected Consolidated Balance Sheet Data](index=5&type=section&id=Selected%20Consolidated%20Balance%20Sheet%20Data) Sionna's balance sheet data as of June 30, 2025, shows a significant increase in cash, cash equivalents, and marketable securities to $337.3 million from $168.0 million, with total assets and stockholders' equity also increasing substantially Selected Consolidated Balance Sheet Data (in thousands) | Metric | June 30, 2025 | December 31, 2024 | Change | | :---------------------------------- | :-------------- | :---------------- | :----- | | Cash, cash equivalents, and marketable securities | $337,270 | $168,043 | +$169,227 | | Working capital | $259,196 | $140,573 | +$118,623 | | Total assets | $352,048 | $185,752 | +$166,296 | | Total stockholders' equity (deficit) | $336,429 | $(163,713) | +$500,142 | - Working capital is defined as **current assets minus current liabilities**[16](index=16&type=chunk)

Q2 2025 Financial and Operational Results Overview [Highlights for Q2 2025](index=1&type=section&id=Highlights_for_Q2%202025) The second quarter of 2025 saw significant improvements in operational efficiency, leading to increased U3O8 extraction and a reduced net loss per share compared to the prior year [Operational Highlights (Q2 2025)](index=1&type=section&id=Operational_Highlights_%28Q2%202025%29) Operational efficiency at Alta Mesa continued to improve, with monthly increases in U3O8 extraction, averaging 2,678 pounds per day in June 2025 - Improvements in operational efficiency at Alta Mesa In-Situ Recovery ("ISR") Uranium CPP and Wellfield continued through Q2 2025, with monthly increases in U3O8 extraction[3](index=3&type=chunk) Daily U3O8 Production (Q2 2025) | Month | Pounds per day | | :---- | :------------- | | June 2025 | 2,678 | | May 2025 | 2,103 | | April 2025 | 1,942 | - U3O8 extraction for Q2 2025 totaled **203,798 pounds**, an increase of **89,983 pounds or 79%** from Q1 2025[4](index=4&type=chunk) [Financial Highlights (Q2 2025)](index=1&type=section&id=Financial_Highlights_%28Q2%202025%29) The company reported a significantly reduced net loss per share and successful sales of U3O8 at favorable prices, alongside a healthy inventory balance Key Financial Metrics (Q2 2025 vs. Q2 2024) | Metric | Q2 2025 | Q2 2024 | Change | | :----------------------- | :------ | :------ | :----- | | Net loss per share | $(0.03) | $(0.12) | Improved | - Sale (delivery) into contract of **60,000 pounds of uranium ("U3O8")** at a sales price of **$61.07** and a weighted average cost of **$42.23**[4](index=4&type=chunk) - Closing balance of **244,204 pounds of U3O8** in inventory at a cost of **$39.63 per pound**[4](index=4&type=chunk) [Highlights for H1 2025](index=1&type=section&id=Highlights_for_H1%202025) The first half of 2025 was marked by substantial U3O8 deliveries into sales contracts and a significant reduction in the weighted average cost of U3O8 sold compared to the previous year [Financial Highlights (H1 2025)](index=1&type=section&id=Financial_Highlights_%28H1%202025%29) The company delivered a substantial amount of U3O8 into sales contracts at a strong average price, while significantly reducing the cost of U3O8 sold. No U3O8 purchases are planned for 2025 Key Financial Metrics (H1 2025 vs. H1 2024) | Metric | H1 2025 | H1 2024 | Change | | :-------------------------------- | :------ | :------- | :----- | | Weighted average cost of U3O8 sold | $59.42/lb | $100.71/lb | Reduced | - Delivery of **350,000 pounds of U3O8** into sales contracts at an average price of **$62.58 per pound**[4](index=4&type=chunk) - No U3O8 has been, nor is forecasted to be, purchased in 2025[4](index=4&type=chunk) - Closing cash and equivalent balance of **$26.9 million** with working capital of **$30.2 million**[4](index=4&type=chunk) Detailed Financials and Costs [Total Costs of U3O8 Sold in Q2 2025](index=2&type=section&id=Total_Costs_of_U3O8_Sold_in_Q2%202025) The total cost of 350,000 pounds of U3O8 sold in Q2 2025 was $59.42 per pound, with extracted uranium having a significantly lower cost per pound compared to purchased uranium Total Costs of U3O8 Sold (Q2 2025) | Category | Pounds U3O8 | Cost ('000) | Cost/pound | | :----------------- | :---------- | :---------- | :--------- | | Total Cost of all Pounds | 350,000 | $20,796 | $59.42 | | Purchased (2024) | 225,000 | $15,430 | $68.58 | | Extracted total cost | 125,000 | $5,365 | $42.92 | | Extracted cash cost | - | $3,607 | $28.86 | | Extracted non-cash cost | - | $1,758 | $14.06 | [Inventory Remaining on Hand (End Q2 2025)](index=2&type=section&id=Inventory_Remaining_on_Hand_%28End%20Q2%202025%29) At the end of Q2 2025, enCore held 244,204 pounds of U3O8 inventory at an average cost of $39.63 per pound, with the majority being lower-cost extracted uranium Inventory Remaining on Hand (End Q2 2025) | Category | Pounds U3O8 | Cost ('000) | Cost/pound | | :----------------- | :---------- | :---------- | :--------- | | Total Cost of Inventory | 244,204 | $9,678 | $39.63 | | Purchased (2024) | 20,000 | $1,188 | $59.42 | | Extracted total cost | 224,204 | $8,490 | $37.87 | | Extracted cash cost | - | $6,098 | $27.20 | | Extracted non-cash cost | - | $2,392 | $10.67 | Operational Developments and Project Overviews [Alta Mesa Project Updates](index=2&type=section&id=Alta_Mesa_Project_Updates) Wellfield development at Alta Mesa's Wellfield 7 continued to expand with 75 new wells, part of an accelerated ramp-up strategy. The project is a 70/30 joint venture with Boss Energy Limited, managed by enCore, with a total operating capacity of 1.5 million pounds uranium per year - Wellfield development at the Alta Mesa Project's Wellfield 7 continued to expand throughout Q2 2025 with the addition of **75 wells** (35 extraction, 40 injection), as part of an ongoing ramp-up strategy[9](index=9&type=chunk) - The Company anticipates increasing the number of drill rigs operating to **30** in Q3 2025, up from **24** at the end of Q2[9](index=9&type=chunk) - The Alta Mesa Uranium Project hosts a fully licensed and constructed ISR Central Processing Plant and operational wellfield, operating under a **70/30 joint venture** with Boss Energy Limited, managed by enCore[10](index=10&type=chunk) - Total operating capacity at the Alta Mesa CPP is **1.5 million pounds uranium per year** with additional drying capacity of **0.5 million pounds**[10](index=10&type=chunk) [Upper Spring Creek ISR Uranium Project](index=2&type=section&id=Upper_Spring_Creek_ISR_Uranium_Project) Significant permitting progress was made for the Upper Spring Creek ISR Uranium Project, with its inclusion in the existing Radioactive Materials License, allowing for construction of wellfields and a Satellite IX Plant. This 100% Company-owned project is planned as a Satellite IX Plant operation for the Rosita CPP - Important permitting progress during Q2 2025 included the Upper Spring Creek ISR Uranium Project in the existing Radioactive Materials License ("RML") from the TCEQ, allowing construction of wellfields and a Satellite Ion Exchange ("IX") Plant[9](index=9&type=chunk) - Construction activities for the Satellite IX Plant commenced during the quarter[9](index=9&type=chunk) - The **100% Company-owned** Upper Spring Creek Project is a planned Satellite ion exchange ("IX") Plant operation for the Rosita CPP[12](index=12&type=chunk) [Rosita ISR Uranium Central Processing Plant](index=3&type=section&id=Rosita_ISR_Uranium_Central_Processing_Plant) The Rosita CPP serves as a central processing hub, receiving uranium-loaded resin from remote Satellite IX Plants across South Texas, enabling cost-effective and modular operations - The Rosita CPP can receive uranium-loaded resin from remote project areas across the South Texas region through a network of Satellite IX Plants[13](index=13&type=chunk) - These modular, efficient, and relocatable IX Plants allow for cost-effective operation across multiple sites without the need to construct full processing facilities at each location[13](index=13&type=chunk) Corporate Information and Disclosures [Investor Information](index=4&type=section&id=Investor_Information) enCore's full interim financial statements and Management's Discussion and Analysis are available in the Company's Quarterly Report on Form 10-Q, filed with the SEC - enCore's interim financial statements, including the accompanying Management's Discussion and Analysis, are available in the Company's Quarterly Report on Form 10-Q, filed with the SEC[14](index=14&type=chunk) - The report can be accessed at www.sec.gov and on enCore's investor relations page at www.encoreuranium.com[14](index=14&type=chunk) [Technical Disclosure and Qualified Person](index=4&type=section&id=Technical_Disclosure_and_Qualified_Person) Technical disclosure in the news release has been reviewed and approved by John M. Seeley, enCore's Chief Geologist and a Qualified Person - John M. Seeley, Ph.D., P.G., C.P.G., enCore's Chief Geologist, and a Qualified Person under Canadian National Instrument 43-101 and S-K 1300, has reviewed and approved the technical disclosure in this news release[15](index=15&type=chunk) [About enCore Energy Corp.](index=4&type=section&id=About_enCore_Energy_Corp.) enCore Energy Corp. positions itself as America's Clean Energy Company™, focused on providing clean, reliable, and affordable fuel for nuclear energy through its ISR uranium operations, with multiple central processing plants and a pipeline of future projects - enCore Energy Corp., America's Clean Energy Company™, is committed to providing clean, reliable, and affordable fuel for nuclear energy[16](index=16&type=chunk) - The company is the only United States uranium company with multiple central processing plants in operation, solely utilizing ISR for uranium extraction[16](index=16&type=chunk) - enCore operates the **100% owned Rosita CPP** in South Texas and manages the **70/30 joint venture** with Boss Energy Ltd. at Alta Mesa[17](index=17&type=chunk) - Future projects in enCore's planned project pipeline include the Dewey-Burdock project in South Dakota and the Gas Hills project in Wyoming[18](index=18&type=chunk) [Cautionary Note Regarding Forward Looking Statements](index=5&type=section&id=Cautionary_Note_Regarding_Forward_Looking_Statements) The press release contains forward-looking statements based on management's expectations, which are subject to significant risks and uncertainties that could cause actual results to differ materially - This press release contains "forward-looking statements" regarding future or potential extraction, success of ISR operations, development plans, and uranium purchase forecasts[21](index=21&type=chunk)[22](index=22&type=chunk) - These statements are not guarantees of future results and are subject to important risks and uncertainties, many beyond the Company's control, that could cause actual results to differ materially[22](index=22&type=chunk) [Non-GAAP Financial Measures](index=6&type=section&id=Non-GAAP_Financial_Measures) The press release includes non-GAAP financial measures such as total cost of extracted pounds and uranium cost per extracted pound, which are used to evaluate operational efficiency but should not be considered in isolation from GAAP results - This press release contains non-GAAP financial measures, including total cost of extracted pounds, uranium cost per extracted pound, total cost of extracted inventory, and uranium cost per pound of extracted inventory[23](index=23&type=chunk) - These non-GAAP measures are used in evaluating the efficiency and cost-effectiveness of the Company's extraction operations and overall cost structure[23](index=23&type=chunk) - The presentation of non-GAAP financial measures should not be considered in isolation or as a substitute for reported results under U.S. GAAP, and may not be comparable to similarly titled measures used by other companies[23](index=23&type=chunk)

[Kymera Therapeutics Q2 2025 Business and Financial Highlights](index=1&type=section&id=Kymera%20Therapeutics%20Q2%202025%20Business%20and%20Financial%20Highlights) The company reports significant pipeline advancements, a new strategic partnership, and a strengthened financial position despite a quarterly net loss [Business Highlights and Pipeline Update](index=1&type=section&id=Business%20Highlights%20and%20Pipeline%20Update) The company advanced its immunology pipeline with positive KT-621 data, progressed KT-579, and secured a strategic partnership and new funding - The company is well-capitalized with approximately **$1 billion in cash** as of July 31, 2025, extending its financial runway into the **second half of 2028**[1](index=1&type=chunk)[2](index=2&type=chunk)[8](index=8&type=chunk) - Entered a strategic partnership with Gilead to develop novel oral molecular glue CDK2 degraders, with potential payments up to **$750 million**[1](index=1&type=chunk)[9](index=9&type=chunk) - Sanofi has prioritized Kymera's second-generation IRAK4 degrader, KT-485, for advancement into Phase 1 clinical studies in 2026[2](index=2&type=chunk)[9](index=9&type=chunk) [STAT6 Degrader Program (KT-621)](index=2&type=section&id=STAT6%20Degrader%20Program%20(KT-621)) The oral STAT6 degrader KT-621 demonstrated a positive Phase 1 profile, with plans to initiate Phase 2b trials in late 2025 and early 2026 - Phase 1 healthy volunteer data surpassed the target product profile, demonstrating **rapid, deep, and prolonged STAT6 degradation**, with complete degradation achieved in both blood and skin at doses ≥50 mg[1](index=1&type=chunk)[3](index=3&type=chunk) - KT-621 showed an impact on Th2 biomarkers comparable or superior to dupilumab, with median **TARC reduction up to 37%** and median **Eotaxin-3 reduction up to 63%**[3](index=3&type=chunk) Upcoming Milestones for KT-621 | Milestone | Indication | Expected Timing | | :--- | :--- | :--- | | Phase 1b (BroADen) Data | Atopic Dermatitis (AD) | 4Q 2025 | | Phase 2b Trial Initiation | Atopic Dermatitis (AD) | 4Q 2025 | | Phase 2b Trial Initiation | Asthma | 1Q 2026 | [IRF5 Degrader Program (KT-579)](index=3&type=section&id=IRF5%20Degrader%20Program%20(KT-579)) The first-in-class oral IRF5 degrader KT-579 is advancing through IND-enabling studies, with a Phase 1 trial anticipated in early 2026 - KT-579 is a **first-in-class oral degrader of IRF5**, a genetically validated transcription factor with potential utility in diseases such as lupus, Sjögren's, inflammatory bowel disease (IBD), and rheumatoid arthritis (RA)[4](index=4&type=chunk) - The program is currently in IND-enabling studies, with a **Phase 1 clinical trial anticipated to commence in early 2026**[1](index=1&type=chunk)[6](index=6&type=chunk) - New preclinical data from lupus and RA animal models will be presented at the American College of Rheumatology (ACR) Annual Meeting in October 2025[6](index=6&type=chunk) [Collaboration and Corporate Updates](index=4&type=section&id=Collaboration%20and%20Corporate%20Updates) The company strengthened its financial position through a new Gilead partnership, a Sanofi milestone payment, and a successful equity offering - Entered an exclusive option and license agreement with Gilead for a CDK2 molecular glue degrader program, with Kymera eligible for up to **$750 million in total payments** plus tiered royalties[9](index=9&type=chunk) - Sanofi prioritized the second-generation IRAK4 degrader KT-485 for Phase 1 testing, triggering a **$20 million milestone payment** to Kymera in Q2 2025, while the first-generation degrader, KT-474, will not be advanced[9](index=9&type=chunk) - Completed an underwritten equity offering with total gross proceeds of approximately **$288 million**, strengthening the company's balance sheet[8](index=8&type=chunk) [Second Quarter 2025 Financial Results](index=5&type=section&id=Second%20Quarter%202025%20Financial%20Results) The company reported lower Q2 2025 revenues and a wider net loss driven by increased R&D expenses, while maintaining a strong cash position Q2 2025 Financial Highlights (vs. Q2 2024) | Metric | Q2 2025 | Q2 2024 | Change | | :--- | :--- | :--- | :--- | | Collaboration Revenues | $11.5M | $25.7M | -55.3% | | R&D Expenses | $78.4M | $59.2M | +32.4% | | G&A Expenses | $17.6M | $17.4M | +1.1% | | Net Loss | ($76.6M) | ($42.1M) | +81.9% | | Net Loss Per Share | ($0.95) | ($0.58) | +63.8% | - The increase in R&D expenses was primarily driven by investments in the **STAT6 program**, platform and discovery programs, and organizational growth[11](index=11&type=chunk) - As of June 30, 2025, the company had **$963.1 million** in cash, cash equivalents, and investments, a balance that grew to approximately **$1 billion** by July 31, 2025, after recent financing activities[14](index=14&type=chunk) [Financial Statements](index=8&type=section&id=Financial%20Statements) This section presents the unaudited consolidated Balance Sheet and Statement of Operations for the period ended June 30, 2025 [Consolidated Balance Sheets](index=8&type=section&id=Consolidated%20Balance%20Sheets) The balance sheet shows total assets grew to $1.13 billion as of June 30, 2025, primarily due to an increase in cash and marketable securities Consolidated Balance Sheets (in thousands) | Account | June 30, 2025 | Dec 31, 2024 | | :--- | :--- | :--- | | **Assets** | | | | Cash, cash equivalents and marketable securities | $963,074 | $850,903 | | Total assets | $1,131,068 | $978,035 | | **Liabilities and Stockholders' Equity** | | | | Total liabilities | $159,588 | $142,416 | | Total stockholders' equity | $971,480 | $835,619 | | Total liabilities and stockholders' equity | $1,131,068 | $978,035 | [Consolidated Statements of Operations and Comprehensive Loss](index=8&type=section&id=Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) The statement of operations details a net loss of $76.6 million for the three months and $142.2 million for the six months ended June 30, 2025 Consolidated Statements of Operations (in thousands) | Account | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | | :--- | :--- | :--- | | Collaboration Revenue | $11,476 | $25,650 | | Total operating expenses | $96,033 | $76,575 | | Loss from operations | ($84,557) | ($50,925) | | Net loss | ($76,614) | ($42,062) | | Net loss per share, basic and diluted | ($0.95) | ($0.58) |