Financial Performance - Grant revenue for Q3 2025 was $209,000, a decrease of 43% compared to $369,000 in Q3 2024[15] - Total operating expenses for Q3 2025 were $28,070,000, up 48% from $19,003,000 in Q3 2024[15] - Net loss for Q3 2025 was $25,969,000, compared to a net loss of $15,122,000 in Q3 2024, representing a 72% increase in losses[15] - Research and development expenses for the nine months ended September 30, 2025, were $51,291,000, a 78% increase from $28,755,000 in the same period of 2024[15] - The company reported a basic and diluted loss per share of $0.35 for Q3 2025, compared to $0.21 for Q3 2024[15] - The net loss for the nine months ended September 30, 2025, was $65.631 million, compared to a net loss of $39.110 million for the same period in 2024[15] - The company experienced a net loss of $25.969 million for the quarter ended September 30, 2025, compared to a net loss of $21.485 million for the quarter ended June 30, 2025[30] Cash Position - The company reported a net cash used in operating activities of $57,827,000 for the nine months ended September 30, 2025, compared to cash provided of $8,312,000 in the same period of 2024[17] - Cash, cash equivalents, and restricted cash at the end of Q3 2025 were $26,762,000, down from $226,443,000 at the end of Q3 2024[17] - As of September 30, 2025, the company reported cash, cash equivalents, and short-term investments of $174.1 million, with a total accumulated deficit of $297.4 million[30] - The Company ended the period with cash, cash equivalents, and restricted cash of $26.762 million, down from $226.443 million at the beginning of the period[17] - The total cash equivalents and available-for-sale securities as of September 30, 2025, were $171.800 million, compared to $225.056 million as of December 31, 2024[80] Equity Financing - The total number of shares outstanding increased from 70,671,464 at December 31, 2024, to 74,337,990 at September 30, 2025, reflecting ongoing equity financing efforts[19] - The company issued 3,379,377 shares of common stock pursuant to an At-the-Market (ATM) offering, raising approximately $9.986 million[19] - The Company entered into a 2024 At-the-Market Agreement allowing for the sale of up to $250.0 million of common stock through ATM Agents[39] - The Company raised approximately $10.2 million from the sale of 3,379,377 shares at an average price of $3.02 per share under the 2024 ATM Agreement on February 18, 2025[43] - The gross proceeds from the May 2024 Registered Offering were approximately $80.0 million before underwriting discounts and commissions[45] - The Company completed a private placement on March 6, 2024, raising approximately $87.4 million from the sale of 9,200,998 shares at $9.50 per share[48] - The Company sold 5,634,235 shares to Lantheus for $50.0 million in a private placement transaction, representing 19.99% of the outstanding shares as of January 8, 2024[51] - The Company raised approximately $69.0 million from a public offering of 13,207,521 shares at $3.70 per share, which closed on January 22, 2024[61] - The Company sold 3,535,246 shares of its Common Stock under the 2023 ATM Agreement at an average price of approximately $14.00 per share, resulting in gross proceeds of approximately $49.5 million[65] Discontinued Operations - The company completed the sale of its Cesium-131 brachytherapy business on April 12, 2024, which has been classified as discontinued operations[27] - The Company recognized a total gain from discontinued operations of $514,000 for the nine months ended September 30, 2025[69] Assets and Liabilities - The Company purchased manufacturing buildings in Houston, Chicago, and Los Angeles, with an aggregate consideration of approximately €49.0 million for equipment and services[73] - The Company's property and equipment, net, increased to $64.351 million as of September 30, 2025, from $57.321 million as of December 31, 2024[74] - The Company holds $50.0 million in indefinite-lived intangible assets related to its pipeline of acquired radiotherapy program candidates[75] - The Company recognized $0.2 million in royalties received pursuant to the GT Medical APA for the period from April 2024 to April 2025[70] - The Company has accrued an estimated liability of $0.2 million related to settlement negotiations with stockholder plaintiff firms as of September 30, 2025[84] - The Company reduced its estimated liability for hazardous waste removal by $0.3 million, resulting in an estimated liability of $0.2 million as of September 30, 2025[98] - The Company obtained a promissory note of $1.7 million for purchasing land and a building, with a balloon payment of approximately $1.5 million due on December 29, 2027[99] - The current portion of the note payable was $55,000 as of September 30, 2025, with a long-term portion of $1.583 million[100] Operational Focus - The company expects to have sufficient cash resources to fund its planned clinical milestones and operational investments into late 2026[8] - The company is focused on obtaining regulatory approvals for its future program candidates, including Fast Track designation for PSV359[8] - The company anticipates potential impacts from U.S. and international trade policies on its costs for supplies and materials[8] - The company has not generated revenue from commercial products and primarily incurs operating expenses in the United States[29] - The company has a history of operating losses and relies primarily on equity financing to support its operations[30] - The Company's operating plan may change due to unknown factors, and there is no assurance that the current plan will be achieved as anticipated[32] Lease Agreements - The company recognized a right-of-use asset and lease liability of approximately $1.1 million upon entering into a lease for lab and office space effective April 1, 2024[91] - The Company recognized a right-of-use asset and lease liability of approximately $0.6 million upon entering a lease for office space in Somerset, NJ, which terminates on November 30, 2028[93] - The Company recognized a right-of-use asset and lease liability of approximately $0.8 million for a lease in Seattle, WA, terminating in October 2028[95] - The Company's operating lease expense was $0.3 million for the three months ended September 30, 2024, and $0.8 million for the nine months ended September 30, 2025[96] - Future operating lease payments total $1.863 million as of September 30, 2025, with a total lease liability of $1.675 million after accounting for imputed interest[97]
IsoRay, Inc.(ISR) - 2026 Q1 - Quarterly Report