REGENXBIO(RGNX) - 2025 Q2 - Quarterly Report

PART I—FINANCIAL INFORMATION Item 1. Financial Statements (Unaudited) This section presents REGENXBIO Inc.'s unaudited consolidated financial statements, including balance sheets, statements of operations and comprehensive loss, statements of stockholders' equity, and statements of cash flows, along with detailed notes explaining the company's accounting policies, financial instruments, and significant agreements for the periods ended June 30, 2025, and December 31, 2024 Consolidated Balance Sheets Consolidated Balance Sheet Highlights (in thousands) | Metric | June 30, 2025 | December 31, 2024 | Change (vs. Dec 31, 2024) | | :-------------------------------- | :------------ | :---------------- | :------------------------ | | Assets | | | | | Cash and cash equivalents | $79,558 | $57,526 | +$22,032 | | Marketable securities | $243,740 | $177,161 | +$66,579 | | Total current assets | $373,752 | $278,001 | +$95,751 | | Total assets | $581,027 | $465,989 | +$115,038 | | Liabilities & Equity | | | | | Deferred revenue (current) | $13,977 | $115 | +$13,862 | | Royalty monetization liabilities (current) | $40,302 | $34,309 | +$5,993 | | Total current liabilities | $119,540 | $103,194 | +$16,346 | | Deferred revenue (non-current) | $23,804 | $— | +$23,804 | | Royalty monetization liabilities (non-current) | $153,693 | $25,378 | +$128,315 | | Total liabilities | $367,348 | $206,338 | +$161,010 | | Total stockholders' equity | $213,679 | $259,651 | -$45,972 | - Total assets increased by $115.0 million, primarily driven by increases in cash, cash equivalents, and marketable securities[17] - Total liabilities significantly increased by $161.0 million, largely due to a substantial rise in royalty monetization liabilities and deferred revenue[17] Consolidated Statements of Operations and Comprehensive Loss Consolidated Statements of Operations and Comprehensive Loss Highlights (in thousands, except per share data) | Metric | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Change (YoY) | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | Change (YoY) | | :-------------------------------- | :------------------------------- | :------------------------------- | :----------- | :------------------------------- | :------------------------------- | :----------- | | License and royalty revenue | $18,465 | $21,846 | -$3,381 | $105,514 | $37,190 | +$68,324 | | Service revenue | $2,894 | $449 | +$2,445 | $4,857 | $727 | +$4,130 | | Total revenues | $21,359 | $22,295 | -$936 | $110,371 | $37,917 | +$72,454 | | Research and development expense | $59,500 | $48,869 | +$10,631 | $112,587 | $103,713 | +$8,874 | | General and administrative expense | $19,883 | $18,855 | +$1,028 | $40,230 | $37,146 | +$3,084 | | Loss from operations | $(63,278) | $(56,037) | -$7,241 | $(51,151) | $(119,900) | +$68,749 | | Interest expense | $(10,993) | $(449) | -$10,544 | $(19,563) | $(2,422) | -$17,141 | | Net loss | $(70,871) | $(52,989) | -$17,882 | $(64,788) | $(116,319) | +$51,531 | | Net loss per share, basic and diluted | $(1.38) | $(1.05) | -$0.33 | $(1.26) | $(2.41) | +$1.15 | - Total revenues for the three months ended June 30, 2025, decreased slightly by $0.9 million year-over-year, primarily due to a $3.4 million decrease in Zolgensma royalty revenue, partially offset by a $2.4 million increase in service revenue from the Nippon Shinyaku collaboration[18][203][204] - For the six months ended June 30, 2025, total revenues significantly increased by $72.5 million, driven by a $70.0 million upfront license revenue from the Nippon Shinyaku collaboration[18][208][209] - Net loss for the three months ended June 30, 2025, widened to $(70.9) million from $(53.0) million in the prior year, largely due to increased research and development expenses and a substantial increase in interest expense from royalty monetization liabilities[18][205][207] - Net loss for the six months ended June 30, 2025, improved to $(64.8) million from $(116.3) million in the prior year, primarily due to the significant increase in license and service revenues, despite higher operating and interest expenses[18][208][210][212] Consolidated Statements of Stockholders' Equity Changes in Stockholders' Equity (in thousands) | Metric | Three Months Ended June 30, 2025 | Six Months Ended June 30, 2025 | | :-------------------------------- | :------------------------------- | :------------------------------- | | Balances at March 31, 2025 / Dec 31, 2024 | $274,197 / $259,651 | $259,651 | | Issuance of warrants, net of transaction costs | $1,610 | $1,610 | | Stock-based compensation expense | $8,653 | $17,190 | | Net loss | $(70,871) | $(64,788) | | Balances at June 30, 2025 | $213,679 | $213,679 | - Total stockholders' equity decreased from $259.7 million at December 31, 2024, to $213.7 million at June 30, 2025, primarily due to the net loss incurred during the period, partially offset by stock-based compensation and warrant issuance[17][24] Consolidated Statements of Cash Flows Consolidated Statements of Cash Flows Highlights (in thousands) | Metric | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | Change (YoY) | | :-------------------------------- | :------------------------------- | :------------------------------- | :----------- | | Net cash used in operating activities | $(15,713) | $(100,952) | +$85,239 | | Net cash provided by (used in) investing activities | $(95,693) | $12,915 | -$108,608 | | Net cash provided by financing activities | $133,438 | $111,280 | +$22,158 | | Net increase in cash and cash equivalents and restricted cash | $22,032 | $23,243 | -$1,211 | - Net cash used in operating activities significantly decreased by $85.2 million, primarily due to the $110.0 million upfront fee from the Nippon Shinyaku collaboration[26][220][221] - Net cash used in investing activities increased by $108.6 million, mainly due to higher purchases of marketable debt securities in 2025 compared to 2024[26][223][224] - Net cash provided by financing activities increased by $22.2 million, driven by proceeds from the 2025 Royalty Bond and warrants, partially offset by royalty monetization repayments[26][225][226] Notes to Consolidated Financial Statements 1. Nature of Business - REGENXBIO Inc. is a clinical-stage biotechnology company focused on gene therapy using its proprietary NAV Technology Platform, which includes exclusive rights to a large portfolio of AAV vectors[29] - The company has incurred cumulative losses of $996.9 million as of June 30, 2025, and relies on additional capital to fund operations, with current cash, cash equivalents, and marketable securities of $363.6 million expected to fund operations for at least the next 12 months[30] 2. Summary of Significant Accounting Policies - The company reclassified service revenue separately from license and royalty revenues retrospectively due to a collaboration and license agreement with Nippon Shinyaku Co., Ltd. in March 2025[36] - Restricted cash of $2.03 million as of June 30, 2025, collateralizes letters of credit for lease agreements[37] - Revenue recognition follows ASC 606, involving a five-step model to identify contracts, performance obligations, transaction price, allocation, and recognition, with specific considerations for variable consideration, milestones, and royalties[43][44][45][52][53][54][55] - New accounting pronouncements include ASU 2023-09 (Income Tax Disclosures, effective Jan 1, 2025) and ASU 2024-03 (Expense Disaggregation Disclosures, effective Jan 1, 2027), with the company currently evaluating their impact[60][61] 3. Marketable Securities Marketable Securities (Available-for-Sale Debt Securities) (in thousands) | Category | Amortized Cost (June 30, 2025) | Fair Value (June 30, 2025) | Amortized Cost (Dec 31, 2024) | Fair Value (Dec 31, 2024) | | :-------------------------------- | :----------------------------- | :------------------------- | :----------------------------- | :------------------------- | | U.S. government and agency securities | $132,032 | $132,019 | $44,281 | $44,215 | | Certificates of deposit | $245 | $245 | $1,466 | $1,462 | | Corporate bonds | $151,649 | $151,772 | $141,474 | $141,663 | | Total | $283,926 | $284,036 | $187,221 | $187,340 | - The company's marketable securities, consisting solely of available-for-sale debt securities, increased significantly from $187.3 million at December 31, 2024, to $284.0 million at June 30, 2025[62] - As of June 30, 2025, the company held 41 investment grade securities in an unrealized loss position, but did not identify any credit losses due to intent and ability to hold until recovery and low severity of losses[64] 4. Fair Value Measurements Fair Value of Cash Equivalents and Marketable Securities (in thousands) | Category | Level 2 (June 30, 2025) | Level 2 (Dec 31, 2024) | | :-------------------------------- | :---------------------- | :--------------------- | | Money market mutual funds | $44,975 | $43,895 | | U.S. government and agency securities | $141,988 | $46,713 | | Certificates of deposit | $245 | $1,462 | | Corporate bonds | $151,772 | $141,663 | | Total cash equivalents and marketable securities | $338,980 | $233,733 | - The fair values of cash equivalents and marketable securities are primarily categorized as Level 2, based on quoted market prices or broker/dealer quotations for similar assets[65][67] - Royalty monetization liabilities are estimated at fair value using Level 3 inputs, based on the company's estimate of future royalties, milestones, and repayment obligations[67] 5. Property and Equipment, Net Property and Equipment, Net (in thousands) | Category | June 30, 2025 | December 31, 2024 | | :-------------------------------- | :------------ | :---------------- | | Laboratory and manufacturing equipment | $77,765 | $77,141 | | Leasehold improvements | $101,533 | $101,465 | | Total property and equipment, net | $111,017 | $117,589 | - Property and equipment, net, decreased from $117.6 million at December 31, 2024, to $111.0 million at June 30, 2025[69] - An impairment of $0.7 million on furniture, fixtures, and leasehold improvements was recorded in Q1 2024 due to a sublease agreement for New York office facilities[69] 6. Leases - The company subleased its New York office space in March 2024, with the sublease term commencing in April 2024 and expiring concurrently with the main lease in April 2027[70][71] - Sublease income of $0.1 million and $0.2 million was recognized for the three and six months ended June 30, 2025, respectively[71] - An impairment loss of $2.1 million was recognized in Q1 2024 on the long-lived asset group associated with the New York Sublease, allocated to right-of-use assets ($1.4 million) and property and equipment ($0.7 million)[73] 7. Royalty Monetization Liabilities Royalty Monetization Liabilities (in thousands) | Agreement | June 30, 2025 | December 31, 2024 | | :-------------------------------- | :------------ | :---------------- | | 2020 Royalty Purchase Agreement | $48,231 | $59,687 | | 2025 Royalty Bond | $145,764 | $— | | Total | $193,995 | $59,687 | | Current portion | $40,302 | $34,309 | | Non-current portion | $153,693 | $25,378 | - Total royalty monetization liabilities increased significantly from $59.7 million at December 31, 2024, to $194.0 million at June 30, 2025, primarily due to the new 2025 Royalty Bond[74] - The 2020 Royalty Purchase Agreement's effective interest rate was 71.4% as of June 30, 2025, up from 65.5% at December 31, 2024, based on estimated future Zolgensma royalty payments[80] - In May 2025, the company entered into a $250.0 million 2025 Royalty Bond with HCR, with an initial funding of $144.5 million (net of discounts/costs). This bond bears interest at 9.75% plus 3-month SOFR (minimum 14.0%) and is repaid from specified royalties and milestones[82][83][84] - In connection with the 2025 Royalty Bond, warrants to purchase 268,096 shares of common stock were issued to HCR, valued at $1.7 million and recorded as additional paid-in capital[86] 8. Commitments and Contingencies Expenses Related to GSK License (in thousands) | Category | Three Months Ended June 30, 2025 | Six Months Ended June 30, 2025 | | :-------------------------------- | :------------------------------- | :------------------------------- | | Royalties on net sales of Zolgensma | $5,204 | $7,786 | | Other cost of license and royalty revenues | $5 | $243 | | General and administrative | $53 | $107 | | Total | $5,262 | $8,136 | - The company has a potential dispute with GlaxoSmithKline (GSK) regarding sublicense fees, with GSK claiming underpayment based on a broader interpretation of sublicense revenue. The company disagrees and does not believe a loss is probable[92] 9. Capitalization - In March 2024, the company completed a public offering, raising $131.1 million net, through the sale of common stock and pre-funded warrants[93] - As of June 30, 2025, 1,125,440 March 2024 Pre-funded Warrants remained outstanding, with 199,300 shares exercised during the six months ended June 30, 2025[95] - The May 2025 Warrants, issued in connection with the 2025 Royalty Bond, allow purchase of 268,096 common shares at $14.92/share, classified as equity, with none exercised as of June 30, 2025[96] - The company has an At-the-Market (ATM) Offering Program established in December 2024 to sell up to $150.0 million of common stock, with no shares sold as of June 30, 2025[97] 10. License and Collaboration Agreements Revenues from License and Collaboration Agreements (in thousands) | Revenue Type | Three Months Ended June 30, 2025 | Six Months Ended June 30, 2025 | | :-------------------------------- | :------------------------------- | :------------------------------- | | Zolgensma royalties | $18,423 | $35,416 | | Nippon Shinyaku licenses | $— | $69,979 | | Other license and royalty revenue | $42 | $119 | | Total license and royalty revenue | $18,465 | $105,514 | | Nippon Shinyaku services | $2,720 | $4,494 | | Other service revenue | $174 | $363 | | Total service revenue | $2,894 | $4,857 | | Total revenues | $21,359 | $110,371 | - Unachieved milestones from license and collaboration agreements could result in aggregate payments of up to $2.18 billion, including $548.2 million for clinical trials, $106.3 million for regulatory approvals, and $1.53 billion for sales targets[99] - Deferred revenue as of June 30, 2025, was $37.8 million, primarily from the Nippon Shinyaku collaboration, expected to be satisfied over approximately five years[101] - The AbbVie Collaboration Agreement was amended in August 2025, modifying the development plan and milestone payment structure for the ABBV-RGX-314 DR program, splitting a $200.0 million milestone into two $100.0 million payments[112][163] - The Nippon Shinyaku Collaboration Agreement, effective March 2025, granted licenses for RGX-121 and RGX-111, with an upfront fee of $110.0 million and potential milestones up to $700.0 million. The company recognized $74.5 million in revenue from this agreement in H1 2025[113][115][164][165] 11. Stock-based Compensation Stock-based Compensation Expense (in thousands) | Award Type | Three Months Ended June 30, 2025 | Six Months Ended June 30, 2025 | | :-------------------------------- | :------------------------------- | :------------------------------- | | Stock options | $4,778 | $9,485 | | Restricted stock units | $3,713 | $7,381 | | Employee stock purchase plan | $162 | $324 | | Total | $8,653 | $17,190 | - The 2015 Equity Incentive Plan expired in June 2025, replaced by the 2025 Equity Incentive Plan, which authorized 5,500,000 shares for issuance[123][124] - As of June 30, 2025, $65.6 million of unrecognized stock-based compensation expense remains, to be recognized over a weighted-average period of 2.5 years[127] 12. Income Taxes - The company maintains a full valuation allowance for its net deferred tax assets due to a history of operating losses, indicating that the benefit of these assets is not likely to be realized[133] - The company is evaluating the impact of the recently enacted One Big Beautiful Bill Act (OBBBA) on its consolidated financial statements, which amends U.S. tax laws related to bonus depreciation and R&D expense deductions[134] 13. Net Loss Per Share - Due to net losses, common stock equivalents (stock options, restricted stock units, employee stock purchase plan, warrants) were excluded from diluted net loss per share calculations as their effect would be anti-dilutive[135] Potentially Dilutive Common Stock Equivalents Excluded (in thousands) | Category | June 30, 2025 | June 30, 2024 | | :-------------------------------- | :------------ | :------------ | | Stock options issued and outstanding | 11,810 | 9,638 | | Unvested restricted stock units outstanding | 2,982 | 1,668 | | Employee stock purchase plan | 111 | 78 | | Warrants outstanding | 268 | — | | Total | 15,171 | 11,384 | 14. Segment Information - The company operates as a single operating segment, focusing on the development and commercialization of gene therapies, with the CEO reviewing consolidated net income (loss) and cash, cash equivalents, and marketable securities for performance assessment and resource allocation[136] - As of June 30, 2025, cash, cash equivalents, and marketable securities were $363.6 million, up from $244.9 million at December 31, 2024[136] 15. Supplemental Disclosures Other Current Assets (in thousands) | Category | June 30, 2025 | December 31, 2024 | | :-------------------------------- | :------------ | :---------------- | | Net cost reimbursement due from AbbVie | $16,989 | $11,304 | | Accrued interest on investments | $1,287 | $1,094 | | Other | $1,203 | $1,376 | | Total | $19,479 | $13,774 | Accrued Expenses and Other Current Liabilities (in thousands) | Category | June 30, 2025 | December 31, 2024 | | :-------------------------------- | :------------ | :---------------- | | Accrued personnel costs | $13,801 | $17,607 | | Accrued external research and development expenses | $11,418 | $8,998 | | Accrued sublicense fees and royalties | $7,548 | $8,658 | | Accrued external general and administrative expenses | $2,015 | $2,002 | | Accrued purchases of property and equipment | $39 | $156 | | Other | $736 | $649 | | Total | $35,557 | $38,070 | - Non-cash financing activities for the six months ended June 30, 2025, included $2.7 million of accrued interest converted to principal balance under the 2025 Royalty Bond[144] Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations This section provides a detailed discussion of REGENXBIO Inc.'s financial condition and results of operations for the three and six months ended June 30, 2025, compared to the same periods in 2024, covering business overview, product pipeline, collaboration agreements, revenue streams, operating expenses, critical accounting policies, and liquidity and capital resources Overview - REGENXBIO is a clinical-stage biotechnology company focused on gene therapy using its proprietary NAV Technology Platform to deliver functional genes for one-time treatments of various diseases[147][148] Overview of Product Candidates - ABBV-RGX-314 (surabgene lomparvovec, sura-vec) is being developed in collaboration with AbbVie for chronic retinal conditions (wet AMD, DR, DME) using both subretinal and suprachoroidal delivery. Topline data from pivotal trials (ATMOSPHERE and ASCENT) for wet AMD subretinal delivery are expected in 2026[148][149] - New ALTITUDE trial data for DR showed durable safety and efficacy through two years with a single, in-office suprachoroidal injection, leading to plans for a pivotal two-part Phase IIb/III trial[152] - RGX-202 for Duchenne muscular dystrophy (Duchenne) showed positive interim safety and efficacy data from the Phase I/II AFFINITY DUCHENNE trial, with pivotal study enrollment expected to complete by October 2025 and BLA submission planned for mid-2026[154][155][156] - RGX-121 for Mucopolysaccharidosis Type II (MPS II) achieved its primary endpoint in the CAMPSIITE trial, demonstrating a reduction in cerebrospinal fluid Heparan sulfate levels. The FDA granted priority review for the BLA submitted in March 2025, with a PDUFA target action date of November 9, 2025[158][159] - RGX-111 for Mucopolysaccharidosis Type I (MPS I) development was halted in November 2023 due to strategic pipeline prioritization, but efforts to continue development are ongoing as part of the Nippon Shinyaku partnership[161] AbbVie Collaboration for ABBV-RGX-314 - The collaboration with AbbVie for ABBV-RGX-314 involves joint development and commercialization, with AbbVie paying an upfront fee of $370.0 million and potential milestones up to $1.38 billion[162] - An August 2025 amendment to the AbbVie Collaboration Agreement modified the development plan and milestone structure for the DR program, splitting a $200.0 million milestone into two $100.0 million payments[163] Nippon Shinyaku Collaboration for RGX-121 and RGX-111 - The January 2025 collaboration with Nippon Shinyaku for RGX-121 and RGX-111 included an upfront payment of $110.0 million and potential milestones up to $700.0 million, with $74.5 million revenue recognized in H1 2025[164][165] - Future royalties and milestones from the Nippon Shinyaku agreement, along with other NAV Technology Platform licenses, will be used to repay principal and interest under the May 2025 Royalty Bond with HCR[166] NAV Technology Licensing Platform - The NAV Technology Platform is licensed to other biotechnology and pharmaceutical companies, with one commercial product (Zolgensma) and several others in preclinical and clinical development, providing additional revenue opportunities and technological validation[167] Financial Overview - Revenues are primarily from licensing the NAV Technology Platform and other intellectual property rights, with Zolgensma royalties being a significant component[168][171] - Operating expenses consist mainly of cost of license and royalty revenues, research and development (R&D), and general and administrative (G&A) expenses, with personnel costs being a significant component[172] - R&D expenses are expected to remain significant due to ongoing product candidate development and early-stage research[177] - Interest expense is primarily associated with royalty monetization liabilities, including the 2020 Royalty Purchase Agreement and the 2025 Royalty Bond with HCR[183] Critical Accounting Policies and Estimates - Revenue recognition under ASC 606 involves a five-step model, requiring significant judgment in identifying performance obligations, determining transaction price (including variable consideration and milestones), and allocating revenue[186][187][193][194][195][196] - The company evaluates collaboration agreements under ASC 808 to determine if transactions are with customers (ASC 606) or collaborative arrangements, applying consistent recognition and presentation methods[191] Results of Operations Key Financial Results (in thousands) | Metric | Three Months Ended June 30, 2025 | Change (YoY) | Six Months Ended June 30, 2025 | Change (YoY) | | :-------------------------------- | :------------------------------- | :----------- | :------------------------------- | :----------- | | Total revenues | $21,359 | -$936 | $110,371 | +$72,454 | | License and royalty revenue | $18,465 | -$3,381 | $105,514 | +$68,324 | | Service revenue | $2,894 | +$2,445 | $4,857 | +$4,130 | | Research and development expense | $59,500 | +$10,631 | $112,587 | +$8,874 | | General and administrative expense | $19,883 | +$1,028 | $40,230 | +$3,084 | | Interest expense | $(10,993) | -$10,544 | $(19,563) | -$17,141 | | Net loss | $(70,871) | -$17,882 | $(64,788) | +$51,531 | - Q2 2025 revenues decreased slightly due to lower Zolgensma royalties, while YTD 2025 revenues significantly increased due to the Nippon Shinyaku upfront payment[203][204][208][209] - R&D expenses increased in both periods, driven by higher manufacturing-related expenses, clinical trial costs for ABBV-RGX-314 and RGX-202, and personnel costs[205][206][210] - Interest expense saw a substantial increase in both periods, primarily due to royalty monetization liabilities from the 2020 Royalty Purchase Agreement and the new 2025 Royalty Bond[207][212] Liquidity and Capital Resources - As of June 30, 2025, the company had $363.6 million in cash, cash equivalents, and marketable securities, which management believes is sufficient to fund operations for at least the next 12 months[213] - Key liquidity sources include $144.5 million (net) from the May 2025 Royalty Bond and a $110.0 million upfront payment from the Nippon Shinyaku Collaboration Agreement in March 2025[213][214][216] - The company expects to incur significant R&D and G&A expenses, requiring additional capital through equity offerings, debt financings, or strategic alliances to fund operations and potential commercialization[217][228] - Future capital requirements are dependent on clinical trial timing and results, regulatory approvals, manufacturing capacity build-out, and the success of licensing agreements[229][236] Cash Flows Cash Flow Summary (in thousands) | Activity | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :-------------------------------- | :------------------------------- | :------------------------------- | | Net cash used in operating activities | $(15,713) | $(100,952) | | Net cash provided by (used in) investing activities | $(95,693) | $12,915 | | Net cash provided by financing activities | $133,438 | $111,280 | | Net increase in cash and cash equivalents and restricted cash | $22,032 | $23,243 | - Net cash used in operating activities decreased by $85.2 million year-over-year, primarily due to the $110.0 million upfront fee from Nippon Shinyaku, which increased deferred revenue[220][221] - Net cash used in investing activities was $(95.7) million, a significant change from $12.9 million provided in the prior year, mainly due to increased purchases of marketable debt securities[223][224] - Net cash provided by financing activities increased to $133.4 million, driven by proceeds from the 2025 Royalty Bond and warrants, partially offset by royalty monetization repayments[225] Off-Balance Sheet Arrangements - The company did not have any off-balance sheet arrangements during the periods presented[232] Item 3. Quantitative and Qualitative Disclosures about Market Risk This section refers to the company's Annual Report on Form 10-K for detailed market risk disclosures and states that there have been no material changes to its exposure to market risk during the six months ended June 30, 2025 - No material changes to market risk exposure occurred during the six months ended June 30, 2025[233] Item 4. Controls and Procedures This section details the evaluation of the effectiveness of the company's disclosure controls and procedures, concluding they were effective as of June 30, 2025, and states there were no material changes in internal control over financial reporting during the quarter - Management, including the CEO and CFO, concluded that disclosure controls and procedures were effective at a reasonable assurance level as of June 30, 2025[234][235] - There were no changes in internal control over financial reporting during the quarter ended June 30, 2025, that materially affected, or are reasonably likely to materially affect, internal control over financial reporting[237] PART II—OTHER INFORMATION Item 1. Legal Proceedings This section states that the company is not currently party to any pending legal actions that could reasonably be expected to have a material adverse effect on its business, financial condition, results of operations, or cash flows - No pending legal actions are expected to have a material adverse effect on the company's business or financial condition[241] Item 1A. Risk Factors This section refers to the material risk factors disclosed in the company's Annual Report on Form 10-K for the year ended December 31, 2024, and confirms that there have been no material changes to these risk factors - No material changes to the risk factors previously disclosed in the Annual Report on Form 10-K for the year ended December 31, 2024[242] Item 2. Unregistered Sales of Equity Securities, Use of Proceeds and Issuer Purchases of Equity Securities This section indicates that there were no unregistered sales of equity securities, use of proceeds, or issuer purchases of equity securities during the reporting period - No unregistered sales of equity securities, use of proceeds, or issuer purchases of equity securities occurred[243] Item 3. Defaults Upon Senior Securities This section states that there were no defaults upon senior securities during the reporting period - No defaults upon senior securities occurred[244] Item 4. Mine Safety Disclosures This section indicates that mine safety disclosures are not applicable to the company - Mine safety disclosures are not applicable[245] Item 5. Other Information This section reports that none of the company's directors or Section 16 reporting officers adopted or terminated any Rule 10b5-1 trading arrangements or non-Rule 10b5-1 trading arrangements during the three months ended June 30, 2025 - No Rule 10b5-1 or non-Rule 10b5-1 trading arrangements were adopted or terminated by directors or Section 16 officers during Q2 2025[246] Item 6. Exhibits This section provides a list of exhibits filed with the Quarterly Report on Form 10-Q, including corporate documents, equity incentive plans, the loan agreement for the 2025 Royalty Bond, and certifications - Exhibits include the 2025 Equity Incentive Plan, forms of stock option and restricted stock unit agreements, and the Loan Agreement for the 2025 Royalty Bond[247] - Certifications from the Chief Executive Officer and Chief Financial Officer are included as Exhibits 31.1, 31.2, and 32.1[247] Signatures This section contains the signatures of the President and Chief Executive Officer, Curran Simpson, and the Chief Financial Officer, Mitchell Chan, certifying the report on behalf of REGENXBIO Inc - The report is signed by Curran Simpson, President and CEO, and Mitchell Chan, CFO, on August 7, 2025[251]