IsoRay, Inc.(ISR)
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GDIT Awarded $988 Million Contract to Modernize Navy C5ISR Systems
Prnewswire· 2026-01-12 22:00
Core Viewpoint - General Dynamics Information Technology (GDIT) has been awarded a $988 million contract to modernize and integrate C5ISR systems for the U.S. Navy, enhancing operational effectiveness and readiness across all surface combatant ships [1][3]. Group 1: Contract Details - The contract, known as Ship and Air Command, Control, Communications, Computers, Combat, Intelligence, Surveillance, and Reconnaissance (C5ISR) Systems Support (SACSS), includes a one-year base period, four one-year options, and a six-month option [1]. - GDIT will provide integration, engineering, procurement, logistics, and installation services for various naval vessels, including guided missile ships, aircraft carriers, and Coast Guard vessels [3]. Group 2: Company Background and Expertise - GDIT has extensive experience in delivering mission-critical services to the Navy, including the development of advanced electronic warfare technologies and training support for over 100,000 U.S. and allied sailors [2][4]. - The company also offers advanced artificial intelligence and machine learning solutions to modernize the Navy Enterprise Service Desk program [4]. - General Dynamics, the parent company of GDIT, is a global aerospace and defense firm with over 110,000 employees and reported $47.7 billion in revenue in 2024 [5].
IsoRay, Inc.(ISR) - 2026 Q2 - Quarterly Results
2026-02-02 12:44
Clinical Trial Updates - Perspective Therapeutics, Inc. announced updated interim data from its Phase 1/2a clinical trial of [212Pb]VMT-α-NET for treating unresectable or metastatic neuroendocrine tumors[8] - The data presentation occurred at the 2026 American Society of Clinical Oncology Gastrointestinal Cancers Symposium held from January 8-10, 2026[8]
Denison Mines' Phoenix ISR Project Ready for Construction Phase
ZACKS· 2026-01-05 14:45
Core Insights - Denison Mines Corp. (DNN) is set to advance its Phoenix In-Situ Recovery (ISR) uranium project into the construction phase, pending final regulatory approval expected in Q1 2026 [1][3] - The Phoenix project is on track to become Canada's first new large-scale uranium mine since Cigar Lake, with a targeted construction period of 24 months and first production aimed for mid-2028 [3][4] - The updated initial capital cost post-FID is approximately $600 million, reflecting inflation and project refinements, including $65 million in contingency funds [3][4] Regulatory and Engineering Progress - Significant progress was made in 2025 regarding regulatory approvals, detailed engineering, procurement, and construction planning, including the completion of the Canadian Nuclear Safety Commission's public hearing process [2] - Construction readiness is bolstered by largely completed detailed engineering, procurement of long-lead items, and near-final construction contracts for 2026 [4] Market Performance - DNN shares have increased by 67.4% over the past six months, outperforming the industry average rise of 18.1% [4]
Denison Reports Readiness to Commence Construction of Flagship Phoenix ISR Project and Provides Capital Cost Update
Prnewswire· 2026-01-02 11:30
Core Viewpoint - Denison Mines Corp. is poised to make a final investment decision and commence construction of the Phoenix In-Situ Recovery uranium mine, pending final regulatory approvals, with first production targeted for mid-2028 [1][3][10]. Regulatory and Construction Readiness - Significant progress has been made in regulatory approvals, engineering, and construction planning throughout 2025, positioning the Phoenix project in a construction-ready state [1][5]. - The Canadian Nuclear Safety Commission (CNSC) public hearing concluded on December 11, 2025, marking the final step in the federal regulatory process [5]. - The project has received provincial environmental assessment approval and initial authorization for certain earthworks from the Province of Saskatchewan [5][10]. Financial Overview - The updated initial capital cost estimate for the Phoenix project is approximately $600 million, reflecting a 20% increase from the 2023 feasibility study due to inflation and project refinements [7][10]. - The updated capital cost includes $65 million in contingency funds, representing about 12.5% of direct and indirect project costs [7][10]. - Denison has a strong financial position with over $700 million in cash, physical uranium, and investments as of September 30, 2025, to fund the initial capital requirements [10]. Project Economics - The project is expected to produce robust economic results, with a base-case adjusted after-tax NPV to initial capital cost factor of 2.6 to 1 and a high internal rate of return [14][20]. - The projected base-case uranium price has increased, contributing to a stable economic outlook despite the rise in initial capital costs [14][19]. - The payback period for post-FID initial capital expenditures is estimated to be around 12 months, with a post-tax NPV of approximately $1.57 billion at the updated uranium price assumptions [15][20]. Project Timeline - If final regulatory approvals are received by the end of Q1 2026, construction is expected to commence shortly thereafter, maintaining the timeline for first production by mid-2028 [1][13].
AIRO Group Announces First U.S.-Produced RQ‑35 ISR Drones Completed at Phoenix Manufacturing Facility
Businesswire· 2025-12-16 12:07
Core Viewpoint - AIRO Group Holdings has successfully completed the first RQ35 Intelligence, Surveillance and Reconnaissance (ISR) drones produced to full operational standard in its U.S. manufacturing facility, marking a significant milestone in its Made-in-America expansion strategy [1] Group 1 - The RQ35 systems are manufactured in Phoenix, Arizona, and are built to the same specifications as those produced at AIRO's facility in Denmark [1] - This achievement represents the first U.S.-manufactured RQ35 systems, indicating a major advancement for the company [1]
IsoRay, Inc.(ISR) - 2026 Q1 - Quarterly Report
2025-11-10 21:23
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]
AIRO to Showcase RQ-35 ISR Drone at GSOF's Modern Warfare Week at Ft. Bragg
Businesswire· 2025-11-06 12:07
Core Viewpoint - AIRO Group Holdings is participating in Modern Warfare Week to showcase its advanced defense technologies and integrated training solutions [1] Company Highlights - AIRO will highlight its RQ-35 Intelligence, Surveillance, and Reconnaissance (ISR) drone at the event [1] - The RQ-35 drone is operated by technology experts and mission veterans from Sky-Watch and Coastal Defense [1] Industry Context - The event is hosted by the Global SOF Foundation (GSOF), indicating a focus on special operations forces and advanced military technologies [1]
IsoRay, Inc.(ISR) - 2026 Q1 - Quarterly Results
2025-11-10 21:20
[Filing Information](index=1&type=section&id=Filing%20Information) This section provides core identification details for Perspective Therapeutics, Inc., including incorporation, executive offices, and registered securities [Registrant Information](index=1&type=section&id=Registrant%20Information) This section details the registrant's legal and contact information, including its state of incorporation and principal executive offices - **Perspective Therapeutics, Inc.** is incorporated in Delaware[2](index=2&type=chunk) - Principal Executive Offices are located at 2401 Elliott Avenue, Suite 320, Seattle, Washington 98121, with telephone (206) 676-0900[2](index=2&type=chunk) Registered Securities | Title of each class | Symbol(s) | Name of each exchange on which registered | | :------------------ | :-------- | :---------------------------------------- | | Common Stock, $0.001 par value | CATX | NYSE American LLC | [Item 2.02 Results of Operations and Financial Condition](index=3&type=section&id=Item%202.02%20Results%20of%20Operations%20and%20Financial%20Condition) The company announced updated interim clinical trial results and preliminary estimated financial information as of September 30, 2025, noting its unaudited nature - On October 20, 2025, the Company announced updated interim results from its Phase 1/2a clinical trial of **[212Pb]VMT-α-NET** for neuroendocrine tumors[6](index=6&type=chunk) - Estimated cash, cash equivalents, and short-term investments as of **September 30, 2025**, were included in the press release and presentation[6](index=6&type=chunk) - All estimated financial information is **preliminary, unaudited**, and not reviewed by WithumSmith+Brown, PC[6](index=6&type=chunk)[7](index=7&type=chunk) [Item 8.01 Other Events and Item 9.01 Financial Statements and Exhibits](index=3&type=section&id=Item%208.01%20Other%20Events%20and%20Item%209.01%20Financial%20Statements%20and%20Exhibits) This section details the filing of a Press Release and Presentation as exhibits to the 8-K report, providing further clinical and business updates - A Press Release and Presentation were issued on **October 20, 2025**, and filed as exhibits to this 8-K report[8](index=8&type=chunk) Exhibits Filed | Exhibit No. | Description | | :------------ | :-------------------------------------------------- | | 99.1 | Press Release dated October 20, 2025. | | 99.2 | Presentation. | | 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document). | [Signatures](index=4&type=section&id=SIGNATURES) The report was officially signed on **October 20, 2025**, by Johan (Thijs) Spoor, CEO of Perspective Therapeutics, Inc., affirming compliance - The report was signed by **Johan (Thijs) Spoor**, Chief Executive Officer of Perspective Therapeutics, Inc., on **October 20, 2025**[14](index=14&type=chunk)
IsoRay, Inc.(ISR) - 2025 Q4 - Annual Report
2025-08-13 11:05
```markdown PART I - FINANCIAL INFORMATION [Item 1 - Financial Statements](index=6&type=section&id=Item%201%20-%20Financial%20Statements) Presents unaudited condensed consolidated financial statements for Q2 2025, covering balance sheets, operations, cash flows, and equity [Condensed Consolidated Balance Sheets](index=6&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) Total assets and equity decreased from December 2024 to June 2025, due to reduced cash and increased accumulated deficit Condensed Consolidated Balance Sheet Data (in thousands) | Metric (in thousands) | June 30, 2025 | December 31, 2024 | Change | % Change | | :-------------------- | :------------ | :---------------- | :----- | :------- | | Cash and cash equivalents | $28,849 | $61,580 | $(32,731) | -53.15% | | Short-term investments | $162,729 | $165,336 | $(2,607) | -1.58% | | Total current assets | $195,958 | $231,160 | $(35,202) | -15.23% | | Total assets | $310,725 | $341,101 | $(30,376) | -8.90% | | Total current liabilities | $12,986 | $18,230 | $(5,244) | -28.77% | | Total liabilities | $45,033 | $50,433 | $(5,400) | -10.71% | | Total stockholders' equity | $265,692 | $290,668 | $(24,976) | -8.59% | | Accumulated deficit | $(271,381) | $(231,719) | $(39,662) | 17.12% | [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) Net loss and operating loss significantly increased in Q2 2025 due to higher R&D and G&A expenses, alongside decreased grant revenue Condensed Consolidated Statements of Operations Data (in thousands, except per-share) | Metric (in thousands, except per-share) | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :------------------------------------ | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Grant revenue | $290 | $526 | $632 | $851 | | Research and development | $16,620 | $9,275 | $30,952 | $16,727 | | General and administrative | $7,709 | $5,514 | $15,551 | $11,392 | | Operating loss | $(24,039) | $(14,263) | $(45,871) | $(27,268) | | Net loss | $(21,485) | $(11,704) | $(39,662) | $(23,988) | | Basic and diluted loss per share | $(0.29) | $(0.18) | $(0.54) | $(0.41) | - Net loss increased by **83.58%** for the three months ended **June 30, 2025**, and by **65.34%** for the six months ended **June 30, 2025**, compared to the respective prior year periods[14](index=14&type=chunk) - Research and development expenses increased by **$7.3 million** (**79.2%**) for the three months and **$14.2 million** (**85.0%**) for the six months ended **June 30, 2025**, reflecting increased clinical activities and personnel costs[14](index=14&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=8&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Q2 2025 saw a shift to negative operating cash flow, reduced investing cash use, and substantially lower financing cash compared to 2024 Condensed Consolidated Cash Flow Data (in thousands) | Cash Flow Activity (in thousands) | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | Change | | :-------------------------------- | :----------------------------- | :----------------------------- | :----- | | Net cash (used in) provided by operating activities | $(41,535) | $4,946 | $(46,481) | | Net cash used in investing activities | $(1,301) | $(50,592) | $49,291 | | Net cash provided by financing activities | $10,105 | $288,412 | $(278,307) | | Net (decrease) increase in cash, cash equivalents and restricted cash | $(32,731) | $242,766 | $(275,497) | - The net decrease in cash, cash equivalents, and restricted cash was **$32.7 million** for the six months ended **June 30, 2025**, a significant reversal from the **$242.8 million** increase in the prior year period[16](index=16&type=chunk) [Condensed Consolidated Statements of Changes in Stockholders' Equity](index=9&type=section&id=Condensed%20Consolidated%20Statements%20of%20Changes%20in%20Stockholders'%20Equity) Stockholders' equity decreased from $290.7 million to $265.7 million due to net loss, partially offset by stock issuance and compensation Condensed Consolidated Stockholders' Equity Data (in thousands, except shares) | Metric (in thousands, except shares) | December 31, 2024 | June 30, 2025 | Change | | :----------------------------------- | :---------------- | :------------ | :----- | | Common Stock Shares | 70,671,464 | 74,262,990 | 3,591,526 | | Common Stock Amount | $70 | $74 | $4 | | Additional Paid-in Capital | $522,368 | $536,996 | $14,628 | | Accumulated Other Comprehensive Income (Loss) | $(51) | $3 | $54 | | Accumulated Deficit | $(231,719) | $(271,381) | $(39,662) | | Total Stockholders' Equity | $290,668 | $265,692 | $(24,976) | - The accumulated deficit increased by **$39.7 million** from **December 31, 2024**, to **June 30, 2025**, reflecting the net loss for the period[18](index=18&type=chunk) [Notes to the Unaudited Condensed Consolidated Financial Statements](index=10&type=section&id=Notes%20to%20the%20Unaudited%20Condensed%20Consolidated%20Financial%20Statements) Detailed notes explain financial statements, covering accounting policies, equity offerings, divestiture, assets, investments, compensation, commitments, and leases [1. Basis of Presentation and Summary of Significant Accounting Policies](index=10&type=section&id=1.%20Basis%20of%20Presentation%20and%20Summary%20of%20Significant%20Accounting%20Policies) Perspective Therapeutics' financials reflect a 2024 divestiture and reverse stock split, with current funds projected into late 2026 - The company completed the sale of its Cesium-131 brachytherapy business on **April 12, 2024**, with financial information presented as discontinued operations[24](index=24&type=chunk) - A **1-for-10** reverse stock split was effected on **June 14, 2024**, retroactively adjusting all historical per share data[25](index=25&type=chunk) - As of **June 30, 2025**, the company had **$191.6 million** in cash, cash equivalents, and short-term investments, which it believes will fund operations into **late 2026**[27](index=27&type=chunk)[28](index=28&type=chunk) [2. Loss per Share](index=12&type=section&id=2.%20Loss%20per%20Share) Loss per share calculations exclude dilutive securities (warrants, options) due to the company's net loss position, rendering them antidilutive Securities Not Considered in Diluted Loss Per Share | Securities not considered in diluted loss per share | June 30, 2025 | June 30, 2024 | | :------------------------------------------------ | :------------ | :------------ | | Common stock warrants | 415,779 | 416,164 | | Common stock options | 10,185,506 | 6,934,022 | | Total potential dilutive securities | 10,601,285 | 7,350,186 | [3. Investments and Agreements](index=14&type=section&id=3.%20Investments%20and%20Agreements) The company engaged in multiple financing activities and strategic agreements in 2024-2025, including ATM, registered, and private offerings, plus a key investment with Lantheus - Under the 2024 ATM Agreement, the company sold **3,379,377 shares** of Common Stock for approximately **$10.2 million** in gross proceeds on **February 18, 2025**[40](index=40&type=chunk) - The **May 2024** Registered Offering generated approximately **$80.0 million** in gross proceeds from the sale of Common Stock and pre-funded warrants[42](index=42&type=chunk) - The **March 2024** Private Placement with institutional investors resulted in approximately **$87.4 million** in gross proceeds from the sale of **9,200,998 shares** of Common Stock[44](index=44&type=chunk)[45](index=45&type=chunk) - The **January 2024** Public Offering generated approximately **$69.0 million** in gross proceeds from the sale of Common Stock and pre-funded warrants[57](index=57&type=chunk)[58](index=58&type=chunk) - Lantheus paid the company a one-time payment of **$28.0 million** under an Option Agreement, with **$1.4 million** recognized as 'Other income from a related party' upon the expiration of certain rights[53](index=53&type=chunk)[56](index=56&type=chunk) [4. Discontinued Operations](index=17&type=section&id=4.%20Discontinued%20Operations) The Cesium-131 brachytherapy business was sold to GT Medical Technologies in April 2024 for stock and royalties, with results reported as discontinued operations - The sale of the Cesium-131 brachytherapy business to GT Medical Technologies, Inc. was completed on **April 12, 2024**[64](index=64&type=chunk) - The company received **279,516 shares** of GT Medical's common stock (**0.5%** fully diluted) and royalty rights on future sales of Cesium-131 brachytherapy seeds and GammaTile Therapy[65](index=65&type=chunk) - During the three and six months ended **June 30, 2025**, the company recognized **$0.2 million** in royalties and reduced its environmental waste disposal reserve by **$0.3 million**[67](index=67&type=chunk) [5. Property and Equipment](index=18&type=section&id=5.%20Property%20and%20Equipment) Net property and equipment increased to $62.6 million by June 2025, reflecting ongoing investments in manufacturing facilities and equipment Property and Equipment Details (in thousands) | Property and Equipment (in thousands) | June 30, 2025 | December 31, 2024 | | :------------------------------------ | :------------ | :---------------- | | Building | $1,770 | $1,770 | | Land | $917 | $917 | | Equipment | $12,510 | $11,423 | | Leasehold improvements | $3,833 | $3,570 | | Construction in progress | $47,991 | $42,601 | | Property and equipment, net | $62,599 | $57,321 | - The company purchased buildings in Houston, Chicago, and Los Angeles in 2024 for manufacturing and entered into an agreement with Comecer SpA to purchase approximately **€49.0 million** in manufacturing equipment[70](index=70&type=chunk) [6. Other Intangible Assets](index=19&type=section&id=6.%20Other%20Intangible%20Assets) Indefinite-lived intangible assets, mainly IPR&D, remained at $50.0 million as of June 2025, with no impairment testing required Intangible Assets (in thousands) | Intangible Assets (in thousands) | June 30, 2025 Net Carrying Value | December 31, 2024 Net Carrying Value | | :------------------------------- | :------------------------------- | :--------------------------------- | | In-process research and development (IPR&D) | $50,000 | $50,000 | [7. Available-for-Sale Securities](index=19&type=section&id=7.%20Available-for-Sale%20Securities) Available-for-sale securities, primarily short-term, totaled $162.7 million as of June 2025, a slight decrease from December 2024, comprising various debt instruments Available-for-Sale Securities (in thousands) | Available-for-Sale Securities (in thousands) | June 30, 2025 Estimated Fair Value | December 31, 2024 Estimated Fair Value | | :------------------------------------------- | :--------------------------------- | :--------------------------------- | | Securities of U.S. government and government agencies | $53,961 | $51,500 | | Commercial paper | $31,726 | $44,473 | | Certificates of deposit | $1,722 | - | | Corporate debt securities | $67,058 | $64,570 | | Asset-backed securities | $8,262 | $4,793 | | Total available-for-sale securities | $162,729 | $165,336 | - The company classifies available-for-sale securities as current assets, intending to use proceeds to fund operations as needed[75](index=75&type=chunk) [8. Fair Value Measurements](index=20&type=section&id=8.%20Fair%20Value%20Measurements) Cash equivalents and available-for-sale securities are measured at fair value using Level 1 and Level 2 inputs, with no Level 3 instruments Fair Value Measurements (in thousands) | Fair Value Measurements (in thousands) | June 30, 2025 Level 1 | June 30, 2025 Level 2 | December 31, 2024 Level 1 | December 31, 2024 Level 2 | | :------------------------------------- | :-------------------- | :-------------------- | :------------------------ | :------------------------ | | Money market funds | $25,095 | - | $46,079 | - | | Securities of U.S. government and government agencies | - | $53,961 | - | $51,500 | | Commercial paper | - | $31,726 | - | $44,473 | | Certificates of deposit | - | $1,722 | - | - | | Corporate debt securities | - | $67,058 | - | $74,233 | | Asset-backed securities | - | $8,262 | - | $4,793 | | Total cash equivalents and available-for-sale securities | $25,095 | $162,729 | $46,079 | $178,977 | [9. Share-Based Compensation](index=21&type=section&id=9.%20Share-Based%20Compensation) Share-based compensation expense significantly increased in Q2 2025 due to higher personnel costs in R&D and G&A functions Share-Based Compensation Expense (in thousands) | Share-Based Compensation Expense (in thousands) | 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 expense | $958 | $259 | $1,855 | $522 | | General and administrative expense | $1,445 | $328 | $2,646 | $687 | | Total share-based compensation expense | $2,403 | $587 | $4,501 | $1,209 | - Total share-based compensation expense increased by **309.4%** for the three months and **272.3%** for the six months ended **June 30, 2025**, compared to the prior year periods[80](index=80&type=chunk) [10. Commitments and Contingencies](index=22&type=section&id=10.%20Commitments%20and%20Contingencies) The company has a $0.2 million lawsuit settlement liability and a $8.4 million commitment to purchase thorium-228 from the DOE in 2025-2026 - The company has accrued **$0.2 million** for an estimated settlement of a stockholder lawsuit[81](index=81&type=chunk) - A 'take-or-pay' provision commits the company to purchasing approximately **$8.4 million** of thorium-228 from the DOE in 2025 and 2026[82](index=82&type=chunk) [11. Related Parties](index=22&type=section&id=11.%20Related%20Parties) Significant related party transactions with Lantheus and Progenics include an investment agreement, a facility purchase, and an option agreement for licensing rights - Lantheus Alpha Therapy, LLC, a subsidiary of Lantheus Holdings, Inc., acquired **5,634,235 shares**, representing **19.99%** of the company's outstanding common stock as of **January 8, 2024**[83](index=83&type=chunk) - The company acquired Progenics' radiopharmaceutical manufacturing facility for **$8.0 million**[84](index=84&type=chunk) - Lantheus was granted an exclusive option to negotiate licensing rights for [212Pb]VMT-α-NET, paying a one-time fee of **$28.0 million**[85](index=85&type=chunk) [12. Leases](index=24&type=section&id=12.%20Leases) New operating leases for lab and office space were entered in 2024, leading to increased operating lease expense in Q2 2025 - New operating leases were recognized for lab and office space in Iowa and a production facility in Somerset, NJ, with right-of-use assets and lease liabilities totaling approximately **$1.4 million**[88](index=88&type=chunk)[89](index=89&type=chunk) - Operating lease expense was **$0.3 million** for the three months and **$0.6 million** for the six months ended **June 30, 2025**, compared to **$0.2 million** and **$0.3 million** for the same periods in 2024[93](index=93&type=chunk) Future Operating Lease Payments (in thousands) | Future Operating Lease Payments (in thousands) | Amount | | :--------------------------------------------- | :----- | | 2025 (remaining six months) | $559 | | 2026 | $647 | | 2027 | $493 | | 2028 | $443 | | Total | $2,142 | | Less: imputed interest | $(224) | | Total lease liability | $1,918 | | Less: current portion | $(847) | | Noncurrent lease liability | $1,071 | [13. Note Payable](index=25&type=section&id=13.%20Note%20Payable) A $1.65 million promissory note, obtained in December 2022 for property, bears 6.15% interest with a balloon payment due in December 2027 Note Payable Details (in thousands) | Note Payable (in thousands) | June 30, 2025 | December 31, 2024 | | :-------------------------- | :------------ | :---------------- | | Note payable | $1,651 | $1,677 | | Less: current portion | $(54) | $(52) | | Note payable, long-term portion | $1,597 | $1,625 | - A balloon payment of approximately **$1.5 million** is due on **December 29, 2027**[96](index=96&type=chunk) [Item 2 - Management's Discussion and Analysis of Financial Condition and Results of Operations](index=26&type=section&id=Item%202%20-%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Overview of radiopharmaceutical development, clinical trial progress, IP, and financial performance, detailing increased operating expenses, liquidity, capital resources, and funding requirements [Overview](index=26&type=section&id=Overview) Perspective Therapeutics develops advanced cancer treatments using proprietary Lead-212 (212Pb) alpha-emitting isotope technology, employing a theranostic approach for personalized outcomes - The company utilizes proprietary technology with the alpha-emitting isotope Lead-212 (212Pb) for targeted radiation delivery to cancer cells[99](index=99&type=chunk) - Its neuroendocrine tumor (VMT-α-NET), melanoma (VMT01), and solid tumor (PSV359) programs are currently in Phase 1/2a imaging and therapy trials in the U.S[100](index=100&type=chunk) [VMT-α-NET](index=26&type=section&id=VMT-%CE%B1-NET) VMT-α-NET, a targeted alpha therapy for neuroendocrine tumors, is in Phase 1/2a trials, showing favorable safety and promising interim efficacy with three confirmed objective responses - VMT-α-NET is a targeted alpha therapy in Phase 1/2a development for unresectable or metastatic SSTR2-expressing neuroendocrine tumors[101](index=101&type=chunk) - As of **April 30, 2025**, **no DLTs**, **no discontinuations due to AEs**, and **no grade 4 or 5 treatment-emergent AEs** were reported among **42 treated patients**[104](index=104&type=chunk) - Updated interim efficacy data for the first nine patients showed **three confirmed objective responses** and one additional unconfirmed response, with **seven patients continuing to experience disease control**[105](index=105&type=chunk) [VMT01](index=28&type=section&id=VMT01) VMT01, a targeted alpha therapy for metastatic melanoma, is in Phase 1/2a trials with FDA Fast Track Designation, showing no DLTs, and is now exploring lower doses and combination therapy - VMT01 targets melanocortin 1 receptor (MC1R) and is in Phase 1/2a clinical trials for metastatic melanoma[111](index=111&type=chunk) - The FDA granted Fast Track Designation for [212Pb]VMT01 in **September 2024**[112](index=112&type=chunk) - Initial results from Cohorts 1 and 2 showed **no DLTs** and **mostly grades 1 and 2 treatment-emergent AEs**[114](index=114&type=chunk) [PSV359](index=30&type=section&id=PSV359) PSV359, a novel cyclic peptide targeting FAP-α, showed favorable tumor targeting in imaging; IND approved in Q1 2025, with first patient treated in April 2025 - PSV359 is a novel cyclic peptide targeting fibroblast activation protein alpha (FAP-α), a pan-cancer target[118](index=118&type=chunk) - First-in-human SPECT/CT imaging of [203Pb]PSV359 revealed strong tumor uptake, fast renal clearance, and low accumulation in normal organs[119](index=119&type=chunk) - The FDA approved the IND application for PSV359 in **Q1 2025**, and the **first patient was treated on April 29, 2025**[121](index=121&type=chunk) [Discovery Program](index=30&type=section&id=Discovery%20Program) The discovery team is developing novel constructs for first-in-human imaging, including a pre-targeting platform, with plans to advance candidates to pre-IND filing - The discovery team is preparing multiple novel constructs for potential first-in-human imaging, including a pre-targeting platform license from Stony Brook University[122](index=122&type=chunk) [Intellectual Property](index=30&type=section&id=Intellectual%20Property) The company secured two U.S. patents and one European patent covering key assets, including 212Pb generation technology, VMT-α-NET, and a lead-specific chelator - A U.S. patent was granted for the company's wholly-owned, proprietary technology for 212Pb generation, expiring in **August 2044**[123](index=123&type=chunk) - A second U.S. patent was granted for the VMT-α-NET compound, licensed from the University of Iowa, expiring in **January 2041**[123](index=123&type=chunk) - A European patent was granted for the lead-specific chelator, licensed from the University of Iowa, expiring in **April 2039**[123](index=123&type=chunk) [Funding Requirements](index=30&type=section&id=Funding%20Requirements) Increased expenses are anticipated for advancing programs and commercialization; while current cash of $191.6 million funds operations into late 2026, additional capital will be needed - Expenses are expected to increase significantly due to continued development of clinical-stage assets (VMT-α-NET, VMT01, PSV359), preclinical programs, regulatory approvals, manufacturing capabilities, and hiring[124](index=124&type=chunk)[126](index=126&type=chunk)[133](index=133&type=chunk) - As of **June 30, 2025**, the company had **$191.6 million** in cash, cash equivalents, and short-term investments, projected to fund operations into **late 2026**[126](index=126&type=chunk) [Manufacturing and Supply](index=32&type=section&id=Manufacturing%20and%20Supply) The company manufactures radiopharmaceutical candidates using 212Pb, combining CMOs and internal sites, with commitments for $8.4 million in thorium-228 and €49.0 million in manufacturing equipment - The company assembles and manufactures radiopharmaceutical candidates by chelating 212Pb to targeting peptides[127](index=127&type=chunk) - A purchase order with the U.S. Department of Energy commits the company to purchasing approximately **$8.4 million** of thorium-228 during 2025 and 2026[128](index=128&type=chunk) - The company agreed to purchase approximately **€49.0 million** in manufacturing equipment and services from Comecer SpA for its production facilities[129](index=129&type=chunk) [Facility Acquisitions](index=32&type=section&id=Facility%20Acquisitions) In 2024, the company acquired manufacturing buildings in Houston, Chicago, and Los Angeles, and operationalized a Somerset, NJ facility that began shipping 212Pb-labeled radiopharmaceuticals in Q4 2024 - Buildings were purchased in Houston, Chicago, and Los Angeles in 2024 for manufacturing program candidates[130](index=130&type=chunk) - The Somerset, NJ manufacturing facility, acquired from a Lantheus affiliate, achieved its first shipment and patient dosing in **October 2024**[131](index=131&type=chunk) [2024 At-the-Market (ATM) Agreement](index=33&type=section&id=2024%20At-the-Market%20(ATM)%20Agreement) The 2024 ATM Agreement allows for selling up to $250.0 million in common stock; $10.2 million in gross proceeds were raised from sales by February 2025 - The 2024 ATM Agreement allows the company to sell up to **$250.0 million** of common stock through ATM Agents[134](index=134&type=chunk) - On **February 18, 2025**, **3,379,377 shares** were sold under the 2024 ATM Agreement, generating approximately **$10.2 million** in gross proceeds[138](index=138&type=chunk) [Brachytherapy Divestiture](index=33&type=section&id=Brachytherapy%20Divestiture) The Cesium-131 brachytherapy business was sold to GT Medical Technologies in April 2024 for stock and future royalties, with $0.2 million recognized in Q2 2025 - The sale of the Cesium-131 brachytherapy business to GT Medical Technologies, Inc. was completed on **April 12, 2024**[139](index=139&type=chunk) - The company received **279,516 shares** of GT Medical's common stock and has the right to receive cash royalty payments for **four years** based on GT Medical's net sales of Cesium-131 brachytherapy seeds and GammaTile Therapy[140](index=140&type=chunk)[143](index=143&type=chunk) - During the three and six months ended **June 30, 2025**, **$0.2 million** in royalties were recognized[140](index=140&type=chunk) [Legislative Update](index=33&type=section&id=Legislative%20Update) The OBBBA tax legislation, signed July 4, 2025, is not expected to materially impact the company's 2025 financial results - The OBBBA tax legislation, signed on **July 4, 2025**, is not expected to materially impact the company's 2025 financial results[142](index=142&type=chunk) [Critical Accounting Policies and Estimates](index=35&type=section&id=Critical%20Accounting%20Policies%20and%20Estimates) No material changes to critical accounting policies and estimates as of June 30, 2025, from those disclosed in the 2024 Form 10-K - No material changes to critical accounting policies and estimates as of **June 30, 2025**[145](index=145&type=chunk) [Results of Operations](index=35&type=section&id=Results%20of%20Operations) Following divestiture, the company operates in a single segment; grant revenue decreased while R&D and G&A expenses significantly increased, leading to a larger operating loss Grant Revenue (in thousands) | Grant Revenue (in thousands) | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--------------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Grant revenue | $290 | $526 | $632 | $851 | - Grant revenue decreased by **$236 thousand** (**44.9%**) for the three months and **$219 thousand** (**25.7%**) for the six months ended **June 30, 2025**[147](index=147&type=chunk) Operating Expenses (in thousands) | Operating Expenses (in thousands) | 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 expenses | $16,620 | $9,275 | $30,952 | $16,727 | | General and administrative expenses | $7,709 | $5,514 | $15,551 | $11,392 | | Total operating expenses | $24,329 | $14,789 | $46,503 | $28,119 | - Total operating expenses increased by **$9.5 million** (**64.5%**) for the three months and **$18.4 million** (**65.3%**) for the six months ended **June 30, 2025**[147](index=147&type=chunk) [Research and Development](index=35&type=section&id=Research%20and%20Development) R&D expenses significantly increased due to heightened clinical activities, drug product costs, and personnel expenses, with further increases expected for novel drugs and manufacturing expansion - Research and development expenses increased by **$7.3 million** (**79.2%**) for the three months and **$14.2 million** (**85.0%**) for the six months ended **June 30, 2025**[149](index=149&type=chunk) - The increase was primarily driven by increased clinical site activities, drug product costs, delivery costs, and higher personnel costs, including share-based compensation[149](index=149&type=chunk) - Management expects R&D expenses to continue increasing due to investments in novel drugs, product candidates, and expansion of manufacturing capabilities, including equipment and modifications for acquired buildings[150](index=150&type=chunk) [General and Administrative](index=36&type=section&id=General%20and%20Administrative) G&A expenses increased in Q2 2025, primarily due to higher personnel costs, including share-based compensation, across various corporate functions - General and administrative expenses increased by **$2.2 million** (**39.8%**) for the three months and **$4.2 million** (**36.6%**) for the six months ended **June 30, 2025**[153](index=153&type=chunk) - The increase was primarily attributable to higher personnel costs, including share-based compensation[153](index=153&type=chunk) [Liquidity and Capital Resources](index=36&type=section&id=Liquidity%20and%20Capital%20Resources) Liquidity decreased with operating cash outflow and reduced financing; while current cash funds operations into late 2026, additional capital will be needed for expanding programs [Cash Flows](index=36&type=section&id=Cash%20Flows) In Q2 2025, operating cash outflow increased, investing cash use decreased, and financing cash provided substantially less compared to 2024 Cash Flow Summary (in thousands) | Cash Flow Activity (in thousands) | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | Change | | :-------------------------------- | :----------------------------- | :----------------------------- | :----- | | Net cash (used in) provided by operating activities | $(41,535) | $4,946 | $(46,481) | | Net cash used in investing activities | $(1,301) | $(50,592) | $49,291 | | Net cash provided by financing activities | $10,105 | $288,412 | $(278,307) | | Net (decrease) increase in cash and cash equivalents | $(32,731) | $242,766 | $(275,497) | - Operating activities shifted from providing **$4.9 million** in cash in 2024 to using **$41.5 million** in 2025, primarily due to changes in operating assets and liabilities and an increased net loss[154](index=154&type=chunk) - Financing activities provided significantly less cash in 2025 (**$10.1 million**) compared to 2024 (**$288.4 million**), reflecting fewer large capital market transactions[156](index=156&type=chunk) [Sources of Liquidity](index=38&type=section&id=Sources%20of%20Liquidity) Operations are financed through equity sales, including a 2024 ATM Agreement ($10.2M sold), a May 2024 Registered Offering ($80.0M), a March 2024 Private Placement ($87.4M), and a January 2024 Public Offering ($69.0M) - The 2024 ATM Agreement allows for the sale of up to **$250.0 million** in common stock, with **$10.2 million** in gross proceeds from sales in **February 2025**[158](index=158&type=chunk)[162](index=162&type=chunk) - The **May 2024** Registered Offering generated approximately **$80.0 million** in gross proceeds from the sale of common stock and pre-funded warrants[163](index=163&type=chunk)[164](index=164&type=chunk) - The **March 2024** Private Placement with institutional investors resulted in approximately **$87.4 million** in gross proceeds[166](index=166&type=chunk) - The **January 2024** Public Offering generated approximately **$69.0 million** in gross proceeds[168](index=168&type=chunk)[169](index=169&type=chunk) [Funding Requirements](index=42&type=section&id=Funding%20Requirements) Increased expenses are expected for advancing programs; current cash ($191.6 million) funds operations into late 2026, but additional dilutive capital will be needed - Expenses are expected to increase due to the advancement of clinical-stage assets (VMT-α-NET, VMT01, PSV359), preclinical programs, regulatory approvals, manufacturing, and commercialization efforts[172](index=172&type=chunk)[175](index=175&type=chunk) - As of **June 30, 2025**, cash, cash equivalents, and short-term investments of **$191.6 million** are believed to be sufficient to fund planned clinical milestones and operational investments into **late 2026**[172](index=172&type=chunk) - The company expects to need to raise additional capital, which may involve public or private equity financings, debt, or strategic alliances, potentially diluting existing stockholders[173](index=173&type=chunk)[177](index=177&type=chunk) [Capital expenditures](index=44&type=section&id=Capital%20expenditures) Management continuously evaluates capital deployment for R&D and G&A to ensure resources for clinical trials, preclinical activities, and product supply - Management regularly reviews capital deployment to support clinical trials, preclinical activities, and product candidate supply[178](index=178&type=chunk) [Financing activities](index=44&type=section&id=Financing%20activities) Future capital needs will be financed through equity sales, collaborations, or debt, likely at a discount and dilutive to stockholders - Future capital is expected to be financed through equity sales, strategic collaborations, or debt financing[179](index=179&type=chunk) - Management anticipates that additional financing will likely be at a discount to the market price and dilutive to stockholders[179](index=179&type=chunk) [Other Commitments and Contingencies](index=44&type=section&id=Other%20Commitments%20and%20Contingencies) No material changes to other commitments and contingencies during Q2 2025 beyond those disclosed in Note 10 of the financial statements - No material changes to other commitments and contingencies outside the ordinary course of business during the six months ended **June 30, 2025**[180](index=180&type=chunk) [Off-Balance Sheet Arrangements](index=44&type=section&id=Off-Balance%20Sheet%20Arrangements) The company has no off-balance sheet arrangements - The company has no off-balance sheet arrangements[181](index=181&type=chunk) [Item 3 - Quantitative and Qualitative Disclosures About Market Risk](index=45&type=section&id=Item%203%20-%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) As a smaller reporting company, Perspective Therapeutics is not required to provide market risk disclosures - The company is a smaller reporting company and is not required to provide quantitative and qualitative disclosures about market risk[182](index=182&type=chunk) [Item 4 - Controls and Procedures](index=45&type=section&id=Item%204%20-%20Controls%20and%20Procedures) Management concluded disclosure controls and procedures were effective as of June 30, 2025, with no material changes in internal control over financial reporting [Evaluation of Disclosure Controls and Procedures](index=45&type=section&id=Evaluation%20of%20Disclosure%20Controls%20and%20Procedures) Principal executive and financial officers concluded disclosure controls and procedures were effective as of June 30, 2025 - Disclosure controls and procedures were evaluated and deemed effective as of **June 30, 2025**[183](index=183&type=chunk) [Changes in Internal Control over Financial Reporting](index=45&type=section&id=Changes%20in%20Internal%20Control%20over%20Financial%20Reporting) No material changes in internal control over financial reporting occurred during the most recent fiscal quarter - No material changes in internal control over financial reporting occurred during the most recent fiscal quarter[184](index=184&type=chunk) PART II - OTHER INFORMATION [Item 1 - Legal Proceedings](index=46&type=section&id=Item%201%20-%20Legal%20Proceedings) The company is not a party to any material legal proceedings and is unaware of any pending or threatened actions that could materially affect its business - The company is not currently a party to any material legal proceedings[185](index=185&type=chunk) [Item 1A - Risk Factors](index=46&type=section&id=Item%201A%20-%20Risk%20Factors) No material changes to the risk factors disclosed in Part I, Item 1A of the company's 2024 Form 10-K - No material changes to the risk factors disclosed in the 2024 Form 10-K[186](index=186&type=chunk) [Item 2 - Unregistered Sales of Equity Securities and Use of Proceeds](index=46&type=section&id=Item%202%20-%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) No unregistered sales of equity securities or use of proceeds to report during the period - No unregistered sales of equity securities or use of proceeds to report[187](index=187&type=chunk) [Item 3 - Defaults Upon Senior Securities](index=46&type=section&id=Item%203%20-%20Defaults%20Upon%20Senior%20Securities) No defaults upon senior securities to report during the period - No defaults upon senior securities to report[188](index=188&type=chunk) [Item 4 - Mine Safety Disclosures](index=46&type=section&id=Item%204%20-%20Mine%20Safety%20Disclosures) Mine safety disclosures are not applicable to the company - Mine safety disclosures are not applicable[189](index=189&type=chunk) [Item 5 - Other Information](index=46&type=section&id=Item%205%20-%20Other%20Information) No directors or executive officers adopted, modified, or terminated Rule 10b5-1 trading arrangements during Q2 2025 [Rule 10b5-1 Trading Arrangements](index=46&type=section&id=Rule%2010b5-1%20Trading%20Arrangements) No directors or executive officers adopted, modified, or terminated Rule 10b5-1 trading arrangements during Q2 2025 - No directors or executive officers adopted, modified, or terminated Rule 10b5-1 trading arrangements during the three months ended **June 30, 2025**[190](index=190&type=chunk) [Item 6 - Exhibits](index=47&type=section&id=Item%206%20-%20Exhibits) Lists exhibits filed with Form 10-Q, including corporate documents, officer certifications, and XBRL instance documents - Exhibits include Amended and Restated Certificate of Incorporation, Certificate of Amendment, Amended and Restated Bylaws, and certifications required by the Sarbanes-Oxley Act[192](index=192&type=chunk) [Signatures](index=48&type=section&id=Signatures) The report is signed by CEO Johan (Thijs) Spoor and CFO Juan Graham on behalf of Perspective Therapeutics, Inc. as of August 13, 2025 - The report is signed by Johan (Thijs) Spoor, Chief Executive Officer, and Juan Graham, Chief Financial Officer, on **August 13, 2025**[193](index=193&type=chunk)[194](index=194&type=chunk) ```
IsoRay, Inc.(ISR) - 2025 Q4 - Annual Results
2025-08-13 10:45
[Executive Summary & Recent Highlights](index=1&type=section&id=Executive%20Summary%20%26%20Recent%20Highlights) [Company Overview & Key Updates](index=1&type=section&id=Company%20Overview%20%26%20Key%20Updates) Perspective Therapeutics, a radiopharmaceutical company, provided a business update and reported Q2 2025 results, highlighting positive interim results for [212Pb]VMT-α-NET, FDA alignment for Cohort 3, upcoming scientific presentations, and a cash runway expected into late 2026 - Perspective Therapeutics is pioneering advanced treatments for cancers using radiopharmaceuticals, specifically the alpha-emitting isotope **212Pb**[2](index=2&type=chunk)[26](index=26&type=chunk) - Interim results from the Phase 1/2a study of [212Pb]VMT-α-NET in neuroendocrine tumors showed objective responses in **4 of 7 patients in Cohort 2**, with **3 confirmed responses**, maintaining a favorable safety profile with **no dose-limiting toxicities**[3](index=3&type=chunk) - The company reached alignment with the FDA in **June 2025** to open Cohort 3 (**6.0 mCi**) of the [212Pb]VMT-α-NET study, with **two patients dosed** as of July 31, 2025[3](index=3&type=chunk)[7](index=7&type=chunk)[9](index=9&type=chunk) - An update on the [212Pb]VMT-α-NET study has been accepted for presentation at the European Society of Medical Oncology Congress 2025 on **October 20, 2025**[3](index=3&type=chunk)[11](index=11&type=chunk) - Cash, cash equivalents, and short-term investments of approximately **$192 million** as of June 30, 2025, are expected to fund current planned clinical milestones and operational investments into **late 2026**[3](index=3&type=chunk)[18](index=18&type=chunk) [Clinical Program Updates](index=2&type=section&id=Clinical%20Program%20Updates) [VMT-α-NET (Neuroendocrine Tumors)](index=2&type=section&id=VMT-%CE%B1-NET%20(Neuroendocrine%20Tumors)) VMT-α-NET, designed to target SSTR2-expressing tumors, is undergoing a Phase 1/2a study, with Cohort 2 enrollment closed, Cohort 3 (6.0 mCi) opened in June 2025 following FDA alignment, and data to be presented at ESMO 2025 - VMT-α-NET is designed to target and deliver **212Pb** to SSTR2-expressing tumor sites in patients with unresectable or metastatic neuroendocrine tumors[5](index=5&type=chunk) - Enrollment for Cohort 2 closed in **2Q 2025**, with a total of **46 patients** having received at least one treatment[6](index=6&type=chunk) - Cohort 3 opened in **June 2025** after FDA alignment, with patients receiving up to four fixed administered doses of [212Pb]VMT-α-NET at **6.0 mCi** every eight weeks (or 100μCi/kg for patients ≤ 60kg), and **two patients** commenced treatment as of July 31, 2025[7](index=7&type=chunk)[9](index=9&type=chunk) - Data on [212Pb]VMT-α-NET have been accepted for a Mini Oral presentation at the European Society of Medical Oncology (ESMO) Congress 2025 on **October 20, 2025**[11](index=11&type=chunk) [VMT01 (Melanoma)](index=3&type=section&id=VMT01%20(Melanoma)) VMT01, an MC1R-targeted RPT, is in a Phase 1/2a study for melanoma, with the SMC recommending exploration of a lower dose of **1.5 mCi** as monotherapy and in combination with nivolumab, both cohorts currently open for enrollment - VMT01 is an MC1R-targeted Radiopharmaceutical Therapy (RPT) that can be radiolabeled with **203Pb** for patient selection/dosimetry or **212Pb** for alpha particle therapy[13](index=13&type=chunk) - The Safety Monitoring Committee (SMC) recommended exploring a lower dose level of **1.5 mCi** per dose for VMT01, both as monotherapy and in combination with the anti-PD-1 antibody nivolumab[13](index=13&type=chunk) - As of July 31, 2025, **five patients** received initial monotherapy treatments of VMT01 at **1.5 mCi**, and **two patients** received treatment in the VMT01 **1.5 mCi** plus nivolumab cohort, with both cohorts open for enrollment[14](index=14&type=chunk) [PSV359 (Solid Tumors)](index=4&type=section&id=PSV359%20(Solid%20Tumors)) PSV359 is designed to target FAP-α expressing solid tumors with **212Pb** for therapy, offering a theranostic approach with **203Pb** or **68Ga** (PSV377) for imaging, with two patients treated and additional site activations in progress - PSV359 targets fibroblast activation protein-α (FAP-α) expressing tumor sites with **212Pb** for therapy, and its targeting moiety can also be radiolabeled with **203Pb** or **68Ga** (PSV377) for diagnostic imaging[16](index=16&type=chunk) - Preclinical and human imaging results suggest the proprietary targeting ligand has improved target engagement and tumor uptake, with reduced retention in healthy tissues[16](index=16&type=chunk) - **Two patients** had been treated with [212Pb]PSV359 as of July 31, 2025, with activation activities underway for additional sites[17](index=17&type=chunk) [Financial Summary](index=4&type=section&id=Financial%20Summary) [Cash Position & Capital Structure](index=4&type=section&id=Cash%20Position%20%26%20Capital%20Structure) Perspective Therapeutics reported approximately **$192 million** in cash, cash equivalents, and short-term investments as of June 30, 2025, a decrease from **$227 million** at December 31, 2024, with its capital structure including **74.3 million** common shares and **10.6 million** warrants/options outstanding Cash, cash equivalents, and short-term investments (in USD) | Metric | June 30, 2025 (USD) | December 31, 2024 (USD) | | :-------------------------------- | :-------------- | :---------------- | | Cash, cash equivalents, and short-term investments | $191,578,000 | $226,916,000 | - The company expects current funding to be sufficient into **late 2026**, supporting clinical programs, pre-IND assets, and regional manufacturing site build-out[18](index=18&type=chunk) - As of June 30, 2025, there were approximately **74.3 million shares** of common stock and **10.6 million warrants and options** outstanding, with all outstanding pre-funded warrants exercised during **Q2 2025**[19](index=19&type=chunk) [Operating Results (Continuing Operations)](index=4&type=section&id=Operating%20Results%20(Continuing%20Operations)) For Q2 2025, grant revenue decreased to **$0.3 million** from **$0.5 million** YoY, while R&D expenses significantly increased by **79%** to **$16.6 million** and G&A expenses rose by **40%** to **$7.7 million**, leading to a net loss of **$21.5 million**, or **$0.29 per share** - The brachytherapy segment was divested in **April 2024** and is classified as discontinued operations[20](index=20&type=chunk) Grant Revenue (Continuing Operations) | Period | 2025 (Millions) | 2024 (Millions) | Change (YoY) | | :-------------------- | :-------------- | :-------------- | :----------- | | Three Months Ended June 30 | $0.3 | $0.5 | -40% | | Six Months Ended June 30 | $0.6 | $0.9 | -33.3% | Research and Development Expenses (Continuing Operations) | Period | 2025 (Millions) | 2024 (Millions) | Change (YoY) | | :-------------------- | :-------------- | :-------------- | :----------- | | Three Months Ended June 30 | $16.6 | $9.3 | +79% | | Six Months Ended June 30 | $31.0 | $16.7 | +85% | - Increase in R&D expenses was primarily due to increased clinical site activities, drug product and delivery costs, and higher personnel costs, including share-based compensation[22](index=22&type=chunk) General and Administrative Expenses (Continuing Operations) | Period | 2025 (Millions) | 2024 (Millions) | Change (YoY) | | :-------------------- | :-------------- | :-------------- | :----------- | | Three Months Ended June 30 | $7.7 | $5.5 | +40% | | Six Months Ended June 30 | $15.6 | $11.4 | +37% | - Increase in G&A expenses was primarily due to increased personnel costs, including share-based compensation[23](index=23&type=chunk) Net Loss and EPS (Continuing Operations) | Period | Net Loss 2025 (Millions) | Net Loss 2024 (Millions) | Loss Per Share 2025 (USD) | Loss Per Share 2024 (USD) | | :-------------------- | :----------------------- | :----------------------- | :------------------------ | :------------------------ | | Three Months Ended June 30 | $(21.5) | $(11.7) | $(0.29) | $(0.18) | | Six Months Ended June 30 | $(39.7) | $(24.0) | $(0.54) | $(0.41) | [About Perspective Therapeutics](index=5&type=section&id=About%20Perspective%20Therapeutics) Perspective Therapeutics is a radiopharmaceutical development company focused on pioneering advanced cancer treatments using its proprietary technology, which utilizes the alpha-emitting isotope **212Pb** with specialized targeting moieties, employing a 'theranostic' approach to personalize treatment - Perspective Therapeutics utilizes proprietary technology with the alpha-emitting isotope **212Pb** to deliver powerful radiation specifically to cancer cells via specialized targeting moieties[26](index=26&type=chunk) - The company is developing complementary imaging diagnostics that incorporate the same targeting moieties, enabling a 'theranostic' approach to personalize treatment and optimize patient outcomes[26](index=26&type=chunk) - Current clinical programs in Phase 1/2a imaging and therapy trials in the U.S. include **VMT-α-NET** (neuroendocrine tumor), **VMT01** (melanoma), and **PSV359** (solid tumor)[27](index=27&type=chunk) - The company is expanding its regional network of drug product candidate finishing facilities, supported by its proprietary **212Pb generator**, for clinical trials and commercial operations[27](index=27&type=chunk) [Forward-Looking Statements & Risks](index=6&type=section&id=Forward-Looking%20Statements%20%26%20Risks) This section outlines forward-looking statements regarding the company's expected cash runway, clinical development plans, timing of data release, market opportunities, and product candidate capabilities, while highlighting significant risks and uncertainties that could cause actual results to differ materially - The press release contains forward-looking statements concerning expected cash runway, preclinical and clinical development plans, timing of clinical data, market opportunities, and product candidate functionality[28](index=28&type=chunk) - Key risks and uncertainties include delays in clinical trials, unanticipated costs, potential impact of FDA changes, early clinical trial results not being indicative of later trials, regulatory approval challenges, manufacturing and supply disruptions, and the sufficiency of cash and cash equivalents[29](index=29&type=chunk) - Investors should not place undue reliance on forward-looking statements, as actual results may differ materially due to various risks detailed in the company's SEC filings[29](index=29&type=chunk)[30](index=30&type=chunk) [Investor Information](index=7&type=section&id=Investor%20Information) This section provides contact information for media and investor relations inquiries for Perspective Therapeutics, including email addresses for direct contact and through Russo Partners, LLC - Contact information for Media and Investor Relations is provided, including **Annie J. Cheng, CFA** (ir@perspectivetherapeutics.com) and **Nic Johnson of Russo Partners, LLC** (PerspectiveIR@russopr.com)[31](index=31&type=chunk) [Financial Statements](index=8&type=section&id=Financial%20Statements) [Condensed Consolidated Balance Sheets](index=8&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) The condensed consolidated balance sheets show a decrease in total assets from **$341.1 million** at December 31, 2024, to **$310.7 million** at June 30, 2025, driven by a reduction in current assets, while total liabilities also decreased from **$50.4 million** to **$45.0 million** Condensed Consolidated Balance Sheets (Selected Items, in thousands USD) | ASSETS | June 30, 2025 (unaudited, thousands USD) | December 31, 2024 (thousands USD) | | :---------------------------------- | :--------------------------------------- | :-------------------------------- | | Cash and cash equivalents | $28,849 | $61,580 | | Short-term investments | $162,729 | $165,336 | | Total current assets | $195,958 | $231,160 | | Property and equipment, net | $62,599 | $57,321 | | Total assets | $310,725 | $341,101 | | LIABILITIES AND STOCKHOLDERS' EQUITY | | | | Total current liabilities | $12,986 | $18,230 | | Total liabilities | $45,033 | $50,433 | | Total stockholders' equity | $265,692 | $290,668 | | Total liabilities and stockholders' equity | $310,725 | $341,101 | [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=9&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) The condensed consolidated statements of operations show a net loss of **$21.5 million** for the three months ended June 30, 2025, an increase from **$11.7 million** in the prior year, driven by significantly higher operating expenses, resulting in a basic and diluted loss per share of **$0.29** Condensed Consolidated Statements of Operations (Selected Items, in thousands USD, except per-share amounts) | 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 | | :---------------------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Grant revenue | $290 | $526 | $632 | $851 | | Research and development | $16,620 | $9,275 | $30,952 | $16,727 | | General and administrative | $7,709 | $5,514 | $15,551 | $11,392 | | Total operating expenses | $24,329 | $14,789 | $46,503 | $28,119 | | Operating loss | $(24,039) | $(14,263) | $(45,871) | $(27,268) | | Net loss from continuing operations | $(21,999) | $(11,214) | $(40,176) | $(23,039) | | Net gain (loss) from discontinued operations | $514 | $(490) | $514 | $(949) | | Net loss | $(21,485) | $(11,704) | $(39,662) | $(23,988) | | Basic and diluted loss per share | $(0.29) | $(0.18) | $(0.54) | $(0.41) |