Table of Contents SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q (Mark One) ☒ Quarterly Report Pursuant to Section 13 or 15 (d) of the Securities Exchange Act of 1934 For the quarterly period ended September 30, 2025 or ☐ Transition Report Pursuant to Section 13 or 15 (d) of the Securities Exchange Act of 1934 For the transition period from to Commission File No. 0-21039 Strategic Education, Inc. (Exact name of registrant as specified in this charter) | Maryland | 52-1975978 | | --- | - ...

Real Estate Investments - As of September 30, 2025, the company held 22 real estate investments, comprising 5,282 residential units, with a consolidated operating investment occupancy rate of approximately 91.8%[177] - The company acquired Southern Pines Reserve, a 272-unit residential community, for $56.6 million, funded by a $30.7 million senior loan, $20.0 million from the KeyBank Credit Facility, and $8.9 million in cash[187] - The company also acquired Skytop Apartments, a 361-unit residential community, for $88.5 million, financed by a $57.5 million senior loan, $22.0 million from the KeyBank Credit Facility, and $13.0 million in cash[188] - A joint venture acquired land in Shawnee, Kansas, for $2.3 million to develop a 188-unit residential community, with a construction loan agreement for up to $46.5 million[190] - The company increased its interest in the Peak JV 2 and Peak JV 3 portfolios from 80% to 100% and from 56% to 100%, respectively, for a total investment of $1.1 million[191] - The company sold 104 consolidated operating units for approximately $18.4 million, generating net proceeds of approximately $13.3 million after mortgage paydown[192] Financial Performance - Rental and other property revenues increased by 38.7% to $16.6 million for the three months ended September 30, 2025, compared to $12.0 million for the same period in 2024[206] - Net operating income for residential communities rose by 121.1% to $4.7 million for the three months ended September 30, 2025, compared to $2.1 million for the same period in 2024[206] - The average occupancy percentage for all units was 91.2% for the three months ended September 30, 2025, an increase of 30 basis points compared to 90.9% for the same period in 2024[206] - The total stockholders' equity decreased by $7.4 million from $139.1 million as of December 31, 2024, to $131.7 million as of September 30, 2025, primarily due to dividends declared of $8.2 million and preferred stock accretion of $3.4 million[202] - Net operating income (NOI) for the three months ended September 30, 2025, was $7,881 thousand, an increase of 42.1% from $5,542 thousand in the same period of 2024[234] - The company experienced a net loss attributable to common stockholders of $(8.621) million for the nine months ended September 30, 2025[263] Cash Flow and Financing - The company had $162.7 million in cash available as of September 30, 2025, and a capacity of $50 million on the KeyBank Credit Facility, with $28 million available for use in the DST Program[241] - The company reported net cash provided by operating activities of $28.3 million for the nine months ended September 30, 2025, following a net loss of $23.1 million[254] - During the same period, net cash used in investing activities was $109.0 million, including $155.7 million for the acquisition of real estate investments[255] - Net cash provided by financing activities was $132.8 million, primarily from borrowings of $88.3 million on mortgages payable and $72.4 million from contributions from noncontrolling interests[257] Occupancy and Rental Rates - Average rent per occupied unit increased by $60, or 3.7%, to $1,695 compared to $1,635 during the prior year period[211] - The average rental rate for scattered single-family homes increased by 3.6% to $1,626 for the three months ended September 30, 2025, compared to $1,570 for the same period in 2024[206] - Consolidated occupancy rate was strong at 93.7% as of September 30, 2025, although future periods may see reduced tenant retention and lease applications[236] Preferred Stock and Dividends - The company has elected to qualify as a REIT, requiring it to distribute at least 90% of its REIT taxable income to stockholders annually[179] - The company declared a monthly dividend of $0.125 for both Class A and Class C common stock, payable from April 2025 to January 2026[265] - The company expects to maintain distributions on its Series A Preferred Stock in accordance with terms requiring monthly dividends, funded by cash flow from operations and other sources[251] Debt and Interest Rate Management - As of September 30, 2025, the company has outstanding mortgage notes payable totaling $404 million, with a weighted average interest rate of 5.48%[271] - The company has a revolving credit facility of $22 million with a weighted average interest rate of 7.76%[271] - Interest rate caps and swaps are in place to manage interest rate risk, covering $100.8 million of the company's debt[273] - A 100-basis point change in interest rates could result in an increase or decrease of approximately $112,000 in interest expense for the quarter ended September 30, 2025[274] - The company is exposed to interest rate risk primarily through its borrowing activities, with inherent roll-over risk as borrowings mature[269] Other Financial Metrics - Depreciation and amortization expenses increased to $21.4 million for the nine months ended September 30, 2025, compared to $13.7 million for the same prior year period[228] - Other income and expense amounted to an expense of $5.0 million for the nine months ended September 30, 2025, compared to income of $8.0 million for the same prior year period[229] - Income tax expense amounted to $1.4 million for the nine months ended September 30, 2025, compared to zero for the same prior year period[231] - Management fees to related party increased to $7.8 million for the nine months ended September 30, 2025, compared to $6.6 million for the same prior year period[226] Strategic Focus - The company’s strategy focuses on generating attractive risk-adjusted returns through acquiring and developing residential units and Value-Add renovations[176] - The company operates in markets with a focus on the knowledge-economy and high-quality of life growth markets in the Sunbelt and Western United States[176] - The company intends to finance long-term liquidity requirements through net proceeds from additional issuances of common and preferred stock, as well as future acquisition or project-based borrowings[247]

Revenue Growth - For the three months ended September 30, 2025, net product revenue increased by $21.2 million or 40.1% to $74.1 million compared to $52.9 million for the same period in 2024[134]. - Recorlev's net revenue rose by $19.2 million or 108.6% for the three months ended September 30, 2025, primarily due to increased patient demand, despite a $1.4 million unfavorable net pricing impact[135]. - Gvoke's net revenue increased by $2.2 million or 9.6% for the three months ended September 30, 2025, reaching $25.2 million compared to $22.9 million in the same period of 2024[134]. - Total revenue for the nine months ended September 30, 2025, was $206.0 million, an increase of $63.1 million or 44.1% compared to $143.0 million for the same period in 2024[134]. - Net revenue increased by $52.3 million or 125.5% for the nine months ended September 30, 2025, primarily driven by higher volume of $56.3 million or 135.1%[136]. - Gvoke's net revenue increased by $2.2 million or 9.6% for the three months ended September 30, 2025, due to higher volume of $0.6 million or 2.7% and favorable net pricing of $1.6 million or 6.9%[137]. - Keveyis' net revenue decreased by $0.3 million or 2.1% for the three months ended September 30, 2025, due to unfavorable net pricing of $1.1 million or 8.8%[139]. Expenses - Research and development expenses for the three months ended September 30, 2025, were $7.5 million, an increase of $1.6 million or 27.1% compared to $5.9 million in the same period of 2024[134]. - Selling, general and administrative expenses for the three months ended September 30, 2025, were $46.5 million, an increase of $1.5 million or 3.3% compared to $45.0 million in the same period of 2024[134]. - Research and development expenses increased by $3.8 million or 19.6% for the nine months ended September 30, 2025, with project-specific expenses for pipeline increasing by $1.4 million or 25.6%[145]. - Selling, general and administrative expenses increased by $11.5 million or 9.3% for the nine months ended September 30, 2025, primarily due to higher personnel-related expenses of $7.9 million[147]. Net Loss and Financial Position - The company reported a net loss of $15.7 million for the nine months ended September 30, 2025, compared to a net loss of $49.7 million for the same period in 2024, reflecting a decrease of $34.0 million or 68.4%[134]. - The accumulated deficit as of September 30, 2025, was $682.4 million, indicating ongoing financial challenges despite revenue growth[121]. - The company has an accumulated deficit of $682.4 million as of September 30, 2025, and expects to incur substantial additional expenditures in the near term[157]. Cash Flow - Net cash provided by operating activities was $8.6 million for the nine months ended September 30, 2025, compared to $39.0 million used in operating activities for the same period in 2024[161]. - Net cash provided by financing activities was $11.7 million for the nine months ended September 30, 2025, driven by proceeds from the exercise of stock awards and issuance of common shares[163]. Patents and Clinical Trials - As of October 31, 2025, the company owned 191 patents globally, including key patents for its glucagon formulation expiring in 2036[120]. - The company plans to initiate a Phase 3 clinical trial for XP-8121, a once-weekly subcutaneous injection of levothyroxine for hypothyroidism[118]. Cost of Goods Sold - Cost of goods sold as a percent of total product revenue improved by 3.8%, to 15.8% for the nine months ended September 30, 2025, primarily due to higher sales of products with a lower cost of goods sold[144]. Foreign Currency Risk - The company is exposed to foreign currency exchange risk due to contracts with organizations outside the United States[169]. - Net foreign currency gains and losses did not have a material effect on the company's results of operations for the three and nine months ended September 30, 2025[169]. Interest Expense - Interest expense decreased by $0.9 million or 3.7% for the nine months ended September 30, 2025, primarily due to a lower principal amount of debt outstanding[150].

Omada Health Reports Third Quarter 2025 Results Revenue of $68 million, up 49%; 53% Member Growth Significant Reduction in Net Loss and First Quarter of Positive Adjusted EBITDA Announces New GLP-1 Prescribing Offering SAN FRANCISCO - November 6, 2025 - Omada Health, Inc. (Nasdaq: OMDA), the virtual between-visit healthcare provider, today reported financial results for the third quarter ended September 30, 2025. 2025 Third Quarter Highlights "Our third quarter results demonstrate the strength of Omada's mu ...

Business Developments - Barfresh Food Group, Inc. provided an update on recent business developments alongside its Q3 2025 financial results on November 6, 2025[4]. - The conference call discussing these results was held at 1:30 PM Pacific Time on November 6, 2025, with a playback available until November 20, 2025[4]. - Barfresh Food Group, Inc. is registered under the trading symbol BRFH on The Nasdaq Stock Market LLC[2]. Financial Performance - The company reported Adjusted Gross Profit and Adjusted EBITDA as key non-GAAP measures to reflect core business performance, aiding in internal budgeting and strategic planning[5][6]. - The company emphasized that Adjusted Gross Profit and Adjusted EBITDA should not be viewed as alternatives to GAAP measures, highlighting their specific use in performance evaluation[7]. - The company has incurred non-recurring costs related to the acquisition of Arps Dairy, Inc. and other operational adjustments, impacting financial results[5]. Forward-Looking Statements - Forward-looking statements indicate expectations for growth and expansion, though they are subject to various risks and uncertainties[8]. - The report includes cautionary statements regarding the reliability of forward-looking statements, advising investors to consider associated risks[8]. Compliance and Documentation - The financial statements and exhibits related to the earnings report are available in the filed documents[10]. - Riccardo Delle Coste signed the report as CEO, affirming the company's compliance with SEC requirements[12].

Financial Performance - Total revenues for Q3 2025 were $27.0 million, a 7.3% year-over-year increase[5] - Service revenues grew 35.5% year-over-year to $11.9 million, driven by increased charger utilization[5] - Adjusted EBITDA for Q3 2025 was a loss of $(8.9) million, an improvement from a loss of $(14.0) million in Q3 2024[24] - Total revenues for the three months ended September 30, 2025, were $27,030 million, an increase from $25,187 million in the same period of 2024, representing a growth of 7.3%[32] - Charging service revenue increased to $7,758 million for the three months ended September 30, 2025, compared to $5,254 million in 2024, marking a growth of 47.6%[32] - For the three months ended September 30, 2025, Blink Charging reported a net loss of $86 million, compared to a net loss of $87.4 million for the same period in 2024[41] - Adjusted EBITDA for the three months ended September 30, 2025, was $(8.87) million, while for the same period in 2024, it was $(14.02) million, indicating an improvement[41] - Blink Charging's Adjusted EPS for the nine months ended September 30, 2025, was $(0.54), compared to $(0.47) for the same period in 2024[41] Cash Flow and Liquidity - Operating cash burn was reduced by 87% sequentially to $2.2 million[5] - Cash, cash equivalents, and marketable securities totaled $23.1 million as of September 30, 2025, down from $55.4 million at the end of 2024[28] - Cash and cash equivalents as of September 30, 2025, were $23,110 million, a decrease from $41,774 million at the end of 2024[35] - The company reported a total cash used in operating activities of $31,540 million for the nine months ended September 30, 2025, compared to $34,830 million in 2024[38] - The company generated $11,168 million in net cash from investing activities for the nine months ended September 30, 2025, compared to a cash outflow of $3,946 million in 2024[38] Expenses and Cost Management - Operating expenses decreased by 26% year-over-year and 15% sequentially, adjusted for non-recurring items[20] - The company eliminated approximately $13 million in annualized operating expenses as part of its BlinkForward strategy[11] - Gross margin improved to 35.8% in Q3 2025, compared to 36.2% in Q3 2024[17] - The company reported a depreciation and amortization expense of $2.56 million for the three months ended September 30, 2025, down from $2.99 million in 2024[41] - Blink Charging's total interest expense for the nine months ended September 30, 2025, was $28 million, a decrease from $475 million in the same period of 2024[41] Assets and Liabilities - Total assets decreased to $171,277 million as of September 30, 2025, from $217,988 million at the end of 2024, a decline of 21.5%[35] - Total liabilities decreased to $80,497 million as of September 30, 2025, from $99,286 million at the end of 2024, a reduction of 18.9%[35] - The company’s total stockholders' equity decreased to $90,780 million as of September 30, 2025, from $118,702 million at the end of 2024, a decline of 23.5%[35] Future Outlook - The company expects continued sequential revenue growth in the second half of 2025, with positive trends into Q4[12] - Blink Charging expects continued sequential revenue growth in the last quarter of 2025, with positive trends anticipated to continue into the fourth quarter[49] - Blink Charging's total revenue streams include both recurring and project-based revenues, with strong momentum expected[49] - Blink is transitioning to contract manufacturing to enhance operational efficiency and scalability[8] - The company has established strategic partnerships to enhance the adoption of its EV charging solutions across various locations[46]

Company Operations and Production - As of September 30, 2025, the company owned mineral and royalty interests in approximately 12.3 million gross acres, with 55% located in the Permian Basin and Mid-Continent[101] - Average daily production across all basins as of September 30, 2025, was 158,350 Boe/d, with the Permian Basin contributing 27,799 Boe/d[102] - The company has 806 drilled but uncompleted wells (DUCs) and 651 permitted locations as of September 30, 2025[103] - The company has interests in over 131,000 gross wells, including over 52,000 wells in the Permian Basin[101] - The total number of active rigs operating on the company's acreage decreased from 90 in September 2024 to 86 in September 2025, with notable changes in the Permian Basin increasing from 47 to 51 rigs[115] Financial Performance - The company declared a quarterly cash distribution of $0.35 per common unit for the quarter ended September 30, 2025, to be paid on November 24, 2025[104] - Oil revenue constituted 64% of total revenue for the three months ended September 30, 2025, down from 73% in the same period of 2024, while natural gas revenue increased from 15% to 23%[116] - Adjusted EBITDA for the three months ended September 30, 2025, was $62.27 million, compared to $63.12 million for the same period in 2024[123] - Cash available for distribution on common units was $43.47 million for the three months ended September 30, 2025, slightly down from $44.23 million in 2024[125] - The net income for the three months ended September 30, 2025, was $22.32 million, compared to $25.81 million in the same period of 2024[123] - Total revenues for the nine months ended September 30, 2025 were $251.4 million, an increase of $8.8 million from $242.6 million for the same period in 2024[134] Commodity Prices and Market Conditions - Oil prices ranged from a high of $80.73 to a low of $58.50 per barrel for the nine months ended September 30, 2025, while natural gas prices ranged from $9.86 to $2.65 per MMBtu[111] - The average daily price for oil in Q3 2025 was $65.78 per barrel, compared to $76.43 in Q3 2024[112] - The geopolitical conflicts, including the ongoing situation in Ukraine and the Middle East, have led to increased volatility in commodity prices, although the company has not yet experienced a material impact on operations[107] - The average price received for oil decreased by 17.5% to $64.42 per Bbl, while the average price for natural gas increased by 66.9% to $2.67 per Mcf for the three months ended September 30, 2025 compared to the same period in 2024[139] Acquisitions and Growth Strategy - The company is actively pursuing acquisitions of mineral and royalty interests, which are a key part of its growth strategy[127] - The Boren Acquisition in January 2025 is a material acquisition that may impact the comparability of results for the three and nine months ended September 30, 2025, and 2024[129] Expenses and Financial Management - General and administrative expenses for the three months ended September 30, 2025 were $10.1 million, an increase of $0.6 million compared to $9.5 million for the same period in 2024[147] - Interest expense for the three months ended September 30, 2025 was $9.8 million, an increase from $6.5 million for the same period in 2024, primarily due to an increase in the overall debt balance[148] - Interest expense increased to $25.4 million for the nine months ended September 30, 2025, up from $20.7 million in 2024, due to a higher overall debt balance[163] - The Board of Directors approved the allocation of 25% of available cash for distribution on common units for the repayment of $12.6 million in outstanding borrowings under the secured revolving credit facility[167] Cash Flows and Financial Position - Cash flows provided by operating activities were $189.2 million for the nine months ended September 30, 2025, a decrease of $5.1 million compared to $194.3 million in 2024[172] - Cash flows used in investing activities increased significantly to $223.4 million for the nine months ended September 30, 2025, primarily due to the Boren Acquisition[173] - Cash flows provided by financing activities were $40.0 million for the nine months ended September 30, 2025, compared to cash used of $190.5 million in 2024, driven by proceeds from the 2025 Equity Offering[174] Risk Management and Derivative Contracts - The company has entered into commodity derivative agreements extending through September 2027 to stabilize prices for a portion of its oil and natural gas production[116] - The company has entered into commodity derivative contracts to mitigate exposure to price volatility in oil and natural gas[187] - Changes in fair values of derivative contracts will be recognized as gains and losses in current period earnings, potentially affecting earnings significantly[190] Tax and Regulatory Environment - The company recognized a reduction in current income tax expense due to the enactment of the One Big Beautiful Bill Act, which included a permanent reduction of the corporate tax rate[109] Other Considerations - Inflation has not materially impacted operations from January 1, 2024, to September 30, 2025, but could affect costs and financial position in the future[194] - As of September 30, 2025, there were no off-balance sheet arrangements reported[184] - The company does not control the volumes or methods of sale for oil, natural gas, and NGLs produced from underlying properties[192]

Financial Performance - Total revenues for the three months ended September 30, 2025, were $5,963,000, a decrease from $33,432,000 in the same period of 2024, representing a decline of approximately 82.1%[19] - The net loss for the three months ended September 30, 2025, was $14,229,000, compared to a net income of $5,736,000 for the same period in 2024, indicating a significant shift in performance[19] - Net income for the nine months ended September 30, 2025, was $9,142,000, a decrease of 29% compared to $12,993,000 for the same period in 2024[26] - Total revenue for the three months ended September 30, 2025, was $5.96 million, a decrease from $33.43 million in the same period of 2024, while total revenue for the nine months ended September 30, 2025, was $75.54 million, down from $100.01 million in 2024[47] - The accumulated deficit as of September 30, 2025, was $682.4 million, slightly improved from $691.6 million at the end of 2024[182] Expenses and Costs - Operating expenses for the three months ended September 30, 2025, totaled $21,731,000, down from $29,321,000 in the same period of 2024, reflecting a decrease of about 26.0%[19] - Research and development expenses for the nine months ended September 30, 2025, were $47,493,000, down from $68,592,000 in the same period of 2024, a decrease of approximately 30.8%[19] - General and administrative expenses for the three months ended September 30, 2025, decreased by $1.5 million to $6.4 million compared to the same period in 2024, primarily due to lower personnel and legal expenses[152] - The Company recorded $2.9 million of stock-based compensation expense related to stock option plans for the nine months ended September 30, 2025[96] - The Company recorded $1.1 million of stock-based compensation expense related to time-based RSUs for the nine months ended September 30, 2025[99] Assets and Liabilities - Total current assets increased to $149,217,000 as of September 30, 2025, compared to $107,305,000 as of December 31, 2024, marking an increase of approximately 38.9%[16] - Total liabilities decreased to $50,865,000 as of September 30, 2025, down from $120,989,000 as of December 31, 2024, representing a reduction of about 57.9%[16] - Stockholders' equity improved to $107,389,000 as of September 30, 2025, compared to a deficit of $456,000 as of December 31, 2024, indicating a positive turnaround[16] Cash Flow and Financing - The company had cash and cash equivalents of $34,185,000 as of September 30, 2025, down from $38,052,000 as of December 31, 2024, a decrease of about 2.3%[16] - Cash provided by financing activities increased significantly to $93.8 million in 2025 from $5.3 million in 2024, mainly due to $93.4 million from common stock issuance[170][171] - The Company completed a public offering in May 2025, raising approximately $93.4 million from the sale of 76,923,076 shares at $1.30 per share[91] - The company expects existing capital resources to fund operations into the second quarter of 2027, but may need to raise additional capital in the future[163] Clinical Development and Research - The company’s PROBODY® therapeutic technology platform is designed for "conditional activation" of drug candidates in the tumor microenvironment, aiming to improve cancer treatment outcomes[29] - The IND for CX-2051 was allowed to proceed by the FDA in January 2024, with a Phase 1 clinical trial commencing in April 2024[124] - CX-2051 was generally well-tolerated, with 94% of patients achieving disease control, and no Grade 4 or 5 treatment-related adverse events reported as of the data cutoff[128] - The Company initiated dose expansions for CX-2051, aiming to enroll approximately 100 patients by the first quarter of 2026[129] - A Phase 1b study of CX-2051 in combination with bevacizumab is expected to begin enrollment in the first quarter of 2026[130] Collaborations and Agreements - Astellas Pharma's collaboration resulted in an upfront payment of $80 million and potential milestone payments totaling approximately $1.6 billion, with tiered royalties from high-single digits to mid-teens percentages on future sales[59] - The collaboration with Bristol Myers Squibb included an upfront payment of $50 million and potential contingent payments of up to $25 million for additional targets[65] - The Moderna Agreement included an upfront payment of $35 million and potential milestone payments of up to $1.2 billion, with tiered royalties on global net sales[74] - The Regeneron Agreement includes an upfront fee of $30.0 million and potential milestone payments of up to approximately $0.8 billion, with additional payments of up to $1.2 billion if the collaboration is expanded[78] Risks and Challenges - The company faces risks related to the lengthy and expensive clinical development process, which may not yield successful outcomes[180] - The company may face significant delays in clinical trials if patient enrollment is insufficient, particularly for trials targeting specific tumor types[211] - Adverse side effects from the company's product candidates could result in significant revenue loss and negatively impact business operations[207] - The company’s ability to raise additional funds may be limited due to declining stock prices and unfavorable market conditions[190]

Corporate Strategy and Financial Overview - Rocket Pharmaceuticals reported a strategic corporate reorganization aimed at maximizing near-term value and extending operational runway, which includes a 30% workforce reduction and a projected 25% decrease in 12-month operating expenses [123]. - The company has raised approximately $1.2 billion from investors since inception to fund its operations and R&D activities [188]. - The company has not generated any revenue from product sales to date and does not expect to do so in the near future [189]. - The company incurred restructuring expenses of approximately $3.3 million in June 2025 due to workforce reduction [200]. - The net loss for the three months ended September 30, 2025, was $50.3 million, a decrease of $16.4 million from a net loss of $66.7 million in 2024 [206]. - The company incurred net losses of $180.6 million for the nine months ended September 30, 2025, and $258.7 million for the year ended December 31, 2024, with an accumulated deficit of $1.40 billion as of September 30, 2025 [219]. - Cash used in operating activities was $155.2 million for the nine months ended September 30, 2025, compared to $162.8 million for the same period in 2024 [221]. - The company had $222.8 million in cash, cash equivalents, and investments as of September 30, 2025, down from $372.3 million as of December 31, 2024 [230]. - The company is dependent on generating cash from operating activities or raising additional capital to finance operations, which may lead to stockholder dilution [220]. - The company has experienced negative cash flows from operations each year since inception, indicating ongoing financial challenges [219]. Research and Development Focus - The company is focusing on advancing its AAV cardiovascular gene therapy platform and responding to the CRL for KRESLADI™, targeting an exceptionally small patient population [123]. - The strategic focus is on developing potentially curative first-in-class gene therapies for rare diseases with significant unmet medical needs [122]. - The company aims to submit BLAs for certain clinical programs and expand its gene therapy platform to additional indications compatible with its technologies [129]. - RP-A501 holds multiple designations including FDA RMAT, Fast Track, Rare Pediatric, and Orphan Drug in the U.S., along with ATMP and PRIME designations in the EU [134]. - The company has global commercialization and development rights to its product candidates under royalty-bearing license agreements [132]. - The company is no longer allocating resources towards regulatory filings for RP-L102 and is exploring external partnerships for its development [179]. - Significant additional R&D efforts are required for drug candidates currently under development, necessitating substantial capital and compliance capabilities [218]. Clinical Trials and Results - The Phase 1 clinical trial of RP-A501 for Danon disease involved seven patients, with a high-dose cohort showing a patient who underwent heart transplant due to advanced disease [135]. - Long-term safety and efficacy results from the Phase 1 study of RP-A501 indicated that all evaluable patients demonstrated LAMP2 protein expression at 12 months, sustained up to 60 months, and a reduction of left ventricular mass index by ≥10% at 12 months [139]. - The Phase 2 pivotal trial of RP-A501 for Danon disease (DD) has enrolled 12 patients, including a pediatric safety run-in of 2 patients, with a dose level of 6.7 x 10^13 GC/kg [147]. - The co-primary endpoints for the trial include a median reduction of 24% in left ventricular mass index (LVMI) and improvements in LAMP2 protein expression [151]. - Cardiac biomarkers showed a median reduction of 84% in cardiac troponin I and 57% in BNP [151]. - The FDA has authorized the resumption of the Phase 2 study with a recalibrated dose of 3.8 x 10^13 GC/kg after a temporary clinical hold due to serious adverse events [155]. - The ongoing Phase 1 study of RP-A601 has completed enrollment in the U.S. and is assessing safety and preliminary efficacy in high-risk patients [161]. - Preliminary data from the Phase 1 study of RP-A601 indicated a 110% and 398% increase in PKP2 protein expression in patients with low baseline levels [163]. - The Phase 1/2 trial of RP-L201 for severe LAD-I treated nine patients, showing 100% survival without the need for allogeneic transplant, with significant reductions in infections and restoration of wound healing capabilities [170]. - The FDA accepted a BLA filing for RP-L201 with priority review, initially set for March 31, 2024, but extended to June 30, 2024, due to additional information requests [171]. Manufacturing and Operational Capacity - The company operates a ~100,000 sq. ft. U.S.-based in-house AAV cGMP manufacturing facility in Cranbury, New Jersey, to support clinical and future commercial endeavors [129]. - The company operates a 103,720 square foot cGMP manufacturing facility in Cranbury, New Jersey, supporting clinical development and potential future commercialization [187]. - The company has successfully produced multiple commercial-grade Danon AAV cGMP batches since 2022, improving product quality for the Phase 2 study [152]. Market and Competitive Landscape - The cardiovascular gene therapy programs target major genetically defined causes of hypertrophic, arrhythmogenic, and dilated cardiomyopathies, impacting over 100,000 patients in the U.S. and EU [129]. - BAG3 mutations are estimated to cause 2.3% to 6.7% of dilated cardiomyopathy (DCM) cases in the U.S., Europe, and Japan, with a prevalence of approximately 30,000 individuals in the U.S. [164]. - The company operates in a highly competitive environment with rapid technological changes, impacting the viability of its product development efforts [218].

Revenue Performance - Total revenues decreased by 91% to $966,000 for the three months ended September 30, 2025, compared to $10.5 million in the same period the prior year[90] - Product sales, net decreased by 12% to $582,000 for the three months ended September 30, 2025, primarily due to the automatic termination of the ANI CSA in Q2 2025[91] - License and collaboration agreement revenue decreased by 98% to $150,000 for the three months ended September 30, 2025, driven by the recognition of remaining deferred revenue related to the 2023 agreement for YUTIQ® product rights[92] - Total revenues for the nine months ended September 30, 2025, were $30.8 million, a decrease of $934,000 or 3% compared to the same period in 2024[101] - Product sales, net decreased by $1.1 million, or 46%, to $1.3 million for the nine months ended September 30, 2025, primarily due to the automatic termination of the ANI CSA[102] - Royalty income increased by $11.5 million, or 830%, to $12.9 million for the nine months ended September 30, 2025, mainly due to the recognition of deferred SWK royalty revenue[104] Expenses and Losses - Research and development expenses increased by 62% to $47.8 million for the three months ended September 30, 2025, compared to $29.5 million in the same period the prior year[90] - Total operating expenses increased by 46% to $63.0 million for the three months ended September 30, 2025, compared to $43.3 million in the same period the prior year[90] - Net loss increased by 103% to $59.7 million for the three months ended September 30, 2025, compared to a net loss of $29.4 million in the same period the prior year[90] - Net loss per share increased by 57% to $(0.85) for the three months ended September 30, 2025, compared to $(0.54) in the same period the prior year[90] - For the nine months ended September 30, 2025, the net loss was $164.4 million, an increase of $74.9 million compared to a net loss of $89.5 million for the same period in 2024[118] - Operating cash outflows for the nine months ended September 30, 2025 totaled $175.1 million, compared to $90.4 million for the same period in 2024, reflecting an increase of $84.7 million[119] Research and Development - DURAVYU™ is currently being evaluated in Phase 3 pivotal trials for wet AMD, with data readout expected to begin in mid-2026[85] - The first patient dosing for pivotal Phase 3 trials evaluating DURAVYU™ for DME is anticipated in Q1 2026[89] - Research and development expenses increased by $72.3 million, or 81%, to $161.8 million for the nine months ended September 30, 2025, attributed to ongoing DURAVYU™ Phase 3 clinical trials[106] Cash and Financing - The company has cash, cash equivalents, and investments totaling $204.0 million as of September 30, 2025, which, along with net proceeds of approximately $162.1 million from an equity financing, will fund operations into Q4 2027[80] - Cash, cash equivalents, and investments in marketable securities totaled $204.0 million as of September 30, 2025, expected to fund operations into the fourth quarter of 2027[115] - Net cash provided by investing activities for the nine months ended September 30, 2025 was $145.5 million, a significant increase of $266.6 million compared to a net cash outflow of $119.7 million in 2024[120] - Net cash provided by financing activities for the nine months ended September 30, 2025 totaled $6.7 million, a decrease of $5.6 million from $12.3 million in 2024[121] - The company issued 495,118 shares of Common Stock in 2025, raising $6.7 million through its ATM program[121] Operational Challenges - The company anticipates continued substantial operating losses for at least the next several years as it develops product candidates and seeks marketing approval[117] - Cash outflows related to changes in working capital for the nine months ended September 30, 2025 were $29.5 million, including $28.6 million of deferred revenue related to licensing agreements[118] - The company reported cash outflows of $29.5 million in working capital adjustments, reflecting ongoing operational challenges[118] - General and administrative expenses increased by $1.5 million, or 12%, to $14.5 million for the three months ended September 30, 2025, mainly due to an increase in contingent liability[98] - Interest income decreased by $1.1 million, or 32%, to $2.3 million for the three months ended September 30, 2025, driven by lower cash available for investment[99] - Non-cash expenses for the nine months ended September 30, 2025 included $21.1 million of stock-based compensation, compared to $28.8 million in 2024[119] - The company incurred $2.3 million for the purchase of property and equipment in 2025, compared to $3.7 million in 2024[120] - Deferred revenue related to the licensing of YUTIQ® product rights to ANI was $22.1 million in 2024, indicating a consistent revenue stream from licensing agreements[119]