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AIRO Group Announces First U.S.-Produced RQ‑35 ISR Drones Completed at Phoenix Manufacturing Facility
Businesswire· 2025-12-16 12:07
announced the successful completion of the first RQ35 Intelligence, Surveillance and Reconnaissance (ISR) drones produced to full operational standard in its U.S. manufacturing facility in Phoenix, Arizona. This marks the first U.S.-manufactured RQ35 systems and a major step forward in the company's MadeinAmerica expansion strategy. The systems—built to the same specifications as those produced at AIRO's Denmark facility—compl. MCLEAN, Va.--(BUSINESS WIRE)-- #AIROGroup--AIRO Group Holdings ("AIRO†) today ...
IsoRay, Inc.(ISR) - 2026 Q1 - Quarterly Report
2025-11-10 21:23
PERSPECTIVE THERAPEUTICS, INC. Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q ☑ 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 Number: 001-33407 (Exact name of registrant as specified in its charter) ...
AIRO to Showcase RQ-35 ISR Drone at GSOF's Modern Warfare Week at Ft. Bragg
Businesswire· 2025-11-06 12:07
MCCLEAN, Va.--(BUSINESS WIRE)-- #AIROGroup--AIRO Group Holdings (Nasdaq: AIRO) is proud to announce its participation in the upcoming Modern Warfare Week, hosted by the Global SOF Foundation (GSOF), where it will showcase its advanced defense technologies and integrated training solutions. At the mid- November event, AIRO will highlight its battle-proven RQ-35 Intelligence, Surveillance, and Reconnaissance (ISR) drone. Operated by technology experts and mission veterans from Sky-Watch and Coastal Defense—tw ...
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) |
Blue Sky Confirms Uranium Discovery Potential at its ISR Corcovo Project, Argentina
Prnewswire· 2025-06-04 11:00
Core Insights - Blue Sky Uranium Corp. has announced promising results from the initial technical review of the Corcovo Uranium Project in Mendoza Province, Argentina, indicating significant potential for in situ recovery (ISR) of uranium [1][2] Project Overview - The Corcovo Project spans 20,000 hectares and is located at the northeastern margin of the oil and gas-producing Neuquén Basin, with geological potential for uranium ISR deposits initially identified by the National Atomic Energy Commission (CNEA) [2] - The project was optioned in 2024 as part of a strategic initiative to enhance the company's long-term uranium resource discovery prospects [2] Technical Review Highlights - The geological team reviewed data from 89 historical oil and gas wells, identifying radiometric anomalies at four stacked horizons, with significant sections up to 10 meters thick along a trend exceeding 10 kilometers [1][3] - The Centenario Formation Core is the primary target, showing radiometric anomalies between 1 and 10 meters thick, with values reaching up to 261 ppm Ueq (0.03 U3O8eq) [3][4] - Estimated porosity values in the target area range from 22% to 30%, indicating favorable conditions for ISR production methodologies [4][5] Deposit Model Comparison - The Corcovo Project's deposit model is compared to the Inkai uranium project in Kazakhstan, which is recognized as a leading ISR mining project, showcasing similar roll-front uranium mineralization characteristics [6] Planned Activities - The company plans to conduct further data acquisition, including a 3D-2D seismic survey and analysis of approximately 200 historical drill holes, to refine the understanding of subsurface geological structures [7] - Additional activities include obtaining water samples from active oil wells and drill cuttings from historic holes to validate gamma-ray data and perform geochemical testing [7] Drill Hole Data Summary - A summary of significant drill holes indicates various uranium equivalent values across different horizons, with notable results from the Centenario Core and Rayoso Channel [8][9]
IsoRay, Inc.(ISR) - 2025 Q3 - Quarterly Report
2025-05-12 20:34
[PART I - FINANCIAL INFORMATION](index=5&type=section&id=PART%20I%20-%20FINANCIAL%20INFORMATION) This section provides the company's unaudited condensed consolidated financial statements and management's discussion and analysis for the reporting period [Item 1 - Financial Statements](index=6&type=section&id=Item%201%20-%20Financial%20Statements) This section presents the unaudited condensed consolidated financial statements, including balance sheets, statements of operations and comprehensive loss, cash flows, and changes in stockholders' equity, along with detailed notes explaining accounting policies, significant transactions, and financial positions for the periods ended March 31, 2025, and December 31, 2024 [Condensed Consolidated Balance Sheets](index=6&type=section&id=Condensed%20Consolidated%20Balance%20Sheets%20as%20of%20March%2031%2C%202025%20(unaudited)%20and%20December%2031%2C%202024) This statement presents the company's financial position, including assets, liabilities, and equity, as of March 31, 2025, and December 31, 2024 Condensed Consolidated Balance Sheets | Metric | March 31, 2025 (unaudited) (in thousands) | December 31, 2024 (in thousands) | | :-------------------------------- | :--------------------------------------- | :------------------------------- | | Cash and cash equivalents | $44,406 | $61,580 | | Short-term investments | $167,296 | $165,336 | | Total current assets | $215,742 | $231,160 | | Total assets | $329,349 | $341,101 | | Total current liabilities | $12,679 | $18,230 | | Total liabilities | $44,704 | $50,433 | | Total stockholders' equity | $284,645 | $290,668 | [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss%20for%20the%20three%20months%20ended%20March%2031%2C%202025%20and%202024%20(unaudited)) This statement details the company's revenues, expenses, and net loss for the three months ended March 31, 2025, and 2024 Condensed Consolidated Statements of Operations and Comprehensive Loss | Metric | Three Months Ended March 31, 2025 (in thousands) | Three Months Ended March 31, 2024 (in thousands) | | :------------------------------------ | :----------------------------------------------- | :----------------------------------------------- | | Grant revenue | $342 | $325 | | Research and development expenses | $14,332 | $7,452 | | General and administrative expenses | $7,842 | $5,878 | | Total operating expenses | $22,174 | $13,330 | | Operating loss | $(21,832) | $(13,005) | | Total non-operating income, net | $3,655 | $1,180 | | Net loss | $(18,177) | $(12,284) | | Basic and diluted loss per share | $(0.25) | $(0.25) | | Weighted average shares (Basic/Diluted) | 72,357 | 49,510 | [Condensed Consolidated Statements of Cash Flows](index=8&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows%20for%20the%20three%20months%20ended%20March%2031%2C%202025%20and%202024%20(unaudited)) This statement outlines the company's cash inflows and outflows from operating, investing, and financing activities for the three months ended March 31, 2025, and 2024 Condensed Consolidated Statements of Cash Flows | Cash Flow Activity | Three Months Ended March 31, 2025 (in thousands) | Three Months Ended March 31, 2024 (in thousands) | | :--------------------------------------- | :----------------------------------------------- | :----------------------------------------------- | | Net cash (used in) provided by operating activities | $(21,582) | $13,848 | | Net cash used in investing activities | $(5,565) | $(47,297) | | Net cash provided by financing activities | $9,973 | $166,328 | | Net (decrease) increase in cash, cash equivalents and restricted cash | $(17,174) | $132,879 | | Cash, cash equivalents and restricted cash end of period | $44,406 | $142,299 | [Condensed Consolidated Statements of Changes in Stockholders' Equity](index=9&type=section&id=Condensed%20Consolidated%20Statements%20of%20Changes%20in%20Stockholders'%20Equity%20for%20the%20three%20months%20ended%20March%2031%2C%202025%20and%202024%20(unaudited)) This statement details changes in the company's stockholders' equity, including common stock, additional paid-in capital, and accumulated deficit, for the three months ended March 31, 2025, and 2024 Condensed Consolidated Statements of Changes in Stockholders' Equity | Metric | Balances at Dec 31, 2024 (in thousands) | Balances at Mar 31, 2025 (in thousands) | | :--------------------------------------- | :-------------------------------------- | :-------------------------------------- | | Common Stock (Shares) | 70,671,464 | 74,050,841 | | Common Stock (Amount) | $70 | $73 | | Additional Paid-in Capital | $522,368 | $534,449 | | Accumulated Other Comprehensive Income (Loss) | $(51) | $19 | | Accumulated Deficit | $(231,719) | $(249,896) | | Total Stockholders' Equity | $290,668 | $284,645 | - Issuance of common stock pursuant to the 2024 "At-the-Market Agreement" resulted in **3,379,377 shares** and **$9,986 thousand** in total equity for the three months ended March 31, 2025[20](index=20&type=chunk) - Share-based compensation contributed **$2,098 thousand** to additional paid-in capital for the three months ended March 31, 2025, compared to **$656 thousand** for the same period in 2024[20](index=20&type=chunk) [Notes to the Unaudited Condensed Consolidated Financial Statements](index=10&type=section&id=Notes%20to%20the%20Unaudited%20Condensed%20Consolidated%20Financial%20Statements) This section provides detailed explanations of the accounting policies, significant transactions, and financial positions presented in the condensed consolidated financial statements [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) This note outlines the company's reporting basis, key accounting policies, and significant events impacting financial statement presentation - The Company is a radiopharmaceutical development company focused on advanced cancer treatments[24](index=24&type=chunk) - The Cesium-131 brachytherapy business was sold on April 12, 2024, and its financial information is presented as discontinued operations[26](index=26&type=chunk) - A **1-for-10 reverse stock split** was effected on June 14, 2024, with all historical per share data retroactively adjusted[27](index=27&type=chunk) - The Company operates as a single operating and reportable segment: radiopharmaceutical development[28](index=28&type=chunk) - Cash, cash equivalents, and short-term investments totaled **$211.7 million** as of March 31, 2025, which is believed to fund current planned operations into late 2026[29](index=29&type=chunk)[30](index=30&type=chunk) [2. Loss per Share](index=12&type=section&id=2.%20Loss%20per%20Share) This note details the calculation of basic and diluted loss per share, including weighted average shares outstanding and potential dilutive securities - Basic and diluted loss per share for the three months ended March 31, 2025, and 2024, was **$(0.25)**[14](index=14&type=chunk) - Weighted average shares used in computing net loss per share were **72,357 thousand** for 2025 and **49,510 thousand** for 2024[14](index=14&type=chunk) Potential Dilutive Securities | Security Type | March 31, 2025 | March 31, 2024 | | :---------------------- | :------------- | :------------- | | Common stock warrants | 415,779 | 438,558 | | Common stock options | 10,170,795 | 5,164,917 | | Total potential dilutive securities | 10,586,574 | 5,603,475 | [3. Investments and Agreements](index=14&type=section&id=3.%20Investments%20and%20Agreements) This note describes significant investment and financing agreements, including equity offerings, private placements, and strategic collaborations - Under the 2024 ATM Agreement, the Company sold **3,379,377 shares** of Common Stock on February 18, 2025, generating gross proceeds of approximately **$10.2 million**[42](index=42&type=chunk) - The May 2024 Registered Offering generated approximately **$80.0 million** in gross proceeds[44](index=44&type=chunk) - The March 2024 Private Placement resulted in gross proceeds of approximately **$87.4 million** from the sale of **9,200,998 shares** of Common Stock[47](index=47&type=chunk) - Through the Lantheus Investment Agreement, Lantheus purchased **5,634,235 shares**, representing **19.99%** of outstanding Common Stock as of January 8, 2024[50](index=50&type=chunk) - The Company acquired Progenics' radiopharmaceutical manufacturing facility for **$8.0 million** in cash[54](index=54&type=chunk) - Lantheus paid the Company a one-time payment of **$28.0 million** for an exclusive option to negotiate a license for [212Pb]VMT-α-NET; **$1.4 million** was recognized as 'Other income from a related party' upon the expiration of certain option rights[55](index=55&type=chunk)[58](index=58&type=chunk) - The January 2024 Public Offering generated approximately **$69.0 million** in gross proceeds[60](index=60&type=chunk) - Sales under the 2023 ATM Agreement on April 11, 2024, generated approximately **$49.5 million** in gross proceeds before its termination on August 12, 2024[64](index=64&type=chunk)[65](index=65&type=chunk) [4. Discontinued Operations](index=18&type=section&id=4.%20Discontinued%20Operations) This note provides financial information related to the sale of the Cesium-131 brachytherapy business, presented as discontinued operations - The sale of the Cesium-131 brachytherapy business to GT Medical Technologies, Inc. was completed on April 12, 2024[66](index=66&type=chunk) - Consideration for the sale included **279,516 shares** of GT Medical's common stock (**0.5%** fully diluted) and future cash royalty payments based on net sales of Cesium-131 brachytherapy seeds and GammaTile Therapy[67](index=67&type=chunk) Discontinued Operations Financial Summary | Metric (in thousands) | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :-------------------- | :-------------------------------- | :-------------------------------- | | Sales, net | $0 | $1,973 | | Gross profit | $0 | $571 | | Total loss from discontinued operations | $0 | $(459) | [5. Property and Equipment](index=19&type=section&id=5.%20Property%20and%20Equipment) This note details the company's property and equipment, including recent acquisitions for future manufacturing capabilities - The Company purchased buildings in Houston, Chicago, and Los Angeles in 2024 for future manufacturing of program candidates[71](index=71&type=chunk) - An agreement with Comecer SpA was made to purchase manufacturing equipment for approximately **€49.0 million**[71](index=71&type=chunk) Property and Equipment, Net | Property and Equipment (in thousands) | March 31, 2025 | December 31, 2024 | | :------------------------------------ | :------------- | :---------------- | | Building | $1,770 | $1,770 | | Land | $917 | $917 | | Equipment | $11,676 | $11,423 | | Other (not placed in service) | $47,004 | $42,601 | | Property and equipment, net | $61,247 | $57,321 | [6. Other Intangible Assets](index=20&type=section&id=6.%20Other%20Intangible%20Assets) This note provides information on the company's indefinite-lived intangible assets, primarily in-process research and development - Indefinite-lived intangible assets, primarily in-process research and development (IPR&D), remained at **$50.0 million** as of March 31, 2025, and December 31, 2024[73](index=73&type=chunk) - No impairment testing was deemed necessary during the three months ended March 31, 2025[73](index=73&type=chunk) [7. Available-for-Sale Securities](index=20&type=section&id=7.%20Available-for-Sale%20Securities) This note details the composition and fair value of the company's available-for-sale securities portfolio Available-for-Sale Securities Portfolio | Security Type (in thousands) | March 31, 2025 (Fair Value) | December 31, 2024 (Fair Value) | | :--------------------------- | :-------------------------- | :----------------------------- | | Securities of U.S. government and government agencies | $48,765 | $51,500 | | Commercial paper | $40,462 | $44,473 | | Certificates of deposit | $1,725 | N/A | | Corporate debt securities | $69,370 | $64,570 | | Asset-backed securities | $6,974 | $4,793 | | Total available-for-sale securities | $167,296 | $165,336 | - Accrued interest receivable on available-for-sale securities increased from **$0.2 million** at December 31, 2024, to **$0.9 million** at March 31, 2025[76](index=76&type=chunk) [8. Fair Value Measurements](index=21&type=section&id=8.%20Fair%20Value%20Measurements) This note provides fair value measurements for financial instruments, categorized by valuation input levels Fair Value Measurements of Financial Instruments | Category (in thousands) | March 31, 2025 (Fair Value) | December 31, 2024 (Fair Value) | | :---------------------- | :-------------------------- | :----------------------------- | | Level 1 (Money market funds) | $41,112 | $46,079 | | Level 2 (Various securities) | $167,296 | $178,977 | | Total cash equivalents and available-for-sale securities | $208,408 | $225,056 | - There were no Level 3 financial instruments measured at fair value on a recurring basis at March 31, 2025, and December 31, 2024[78](index=78&type=chunk) [9. Share-Based Compensation](index=22&type=section&id=9.%20Share-Based%20Compensation) This note details share-based compensation expenses and changes in the company's equity incentive plan Share-Based Compensation Expense | Expense Category (in thousands) | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :------------------------------ | :-------------------------------- | :-------------------------------- | | Research and development expense | $897 | $263 | | General and administrative expense | $1,201 | $359 | | Total share-based compensation expense | $2,098 | $622 | - The aggregate number of shares authorized for issuance under the Amended and Restated 2020 Equity Incentive Plan increased by **4,870,092** to a total of **12,500,000 shares**[80](index=80&type=chunk) - An additional **3,533,573 shares** were registered for 2025 under the plan's "evergreen" provision[80](index=80&type=chunk) [10. Commitments and Contingencies](index=23&type=section&id=10.%20Commitments%20and%20Contingencies) This note outlines the company's legal accruals and significant purchase commitments - The Company has an accrual of **$0.2 million** for an estimated legal settlement as of March 31, 2025, and December 31, 2024[82](index=82&type=chunk) - A "take-or-pay" provision commits the Company to purchasing approximately **$8.4 million** of thorium-228 from the U.S. Department of Energy during 2025 and 2026[83](index=83&type=chunk) [11. Related Parties](index=23&type=section&id=11.%20Related%20Parties) This note describes transactions and agreements with related parties, including investment and facility acquisition details - Lantheus purchased **5,634,235 shares** of Common Stock, representing **19.99%** of outstanding shares as of January 8, 2024, through the Lantheus Investment Agreement[84](index=84&type=chunk) - The Company acquired a manufacturing facility from Progenics, an affiliate of Lantheus, for **$8.0 million**[85](index=85&type=chunk) - Lantheus was granted an exclusive option for [212Pb]VMT-α-NET, with a one-time payment of **$28.0 million**; **$1.4 million** was recognized as 'Other income from a related party' upon the expiration of certain option rights[86](index=86&type=chunk)[87](index=87&type=chunk) [12. Leases](index=25&type=section&id=12.%20Leases) This note provides information on the company's operating lease arrangements and future payment obligations - The weighted average remaining term for operating leases was **2.9 years**, and the weighted average discount rate was **8%** as of March 31, 2025[94](index=94&type=chunk) - Operating lease expense was **$0.3 million** for the three months ended March 31, 2025, compared to de minimis for the same period in 2024[94](index=94&type=chunk) Future Operating Lease Payments | Year Ending December 31, | Future Operating Lease Payments (in thousands) | | :----------------------- | :--------------------------------------------- | | 2025 (remaining nine months) | $836 | | 2026 | $647 | | 2027 | $493 | | 2028 | $443 | | Total lease liability | $2,154 | - An estimated liability of **$0.5 million** for hazardous waste removal related to prior activities remains, despite the Asset Retirement Obligation for the Richland, WA facility being assigned to GT Medical[96](index=96&type=chunk) [13. Note Payable](index=26&type=section&id=13.%20Note%20Payable) This note details the company's note payable, including its current and long-term portions and balloon payment schedule Note Payable Summary | Note Payable (in thousands) | March 31, 2025 | December 31, 2024 | | :-------------------------- | :------------- | :---------------- | | Note payable | $1,664 | $1,677 | | Less: current portion | $(53) | $(52) | | Note payable, long-term portion | $1,611 | $1,625 | - A balloon payment of approximately **$1.5 million** for the promissory note is due on December 29, 2027[97](index=97&type=chunk) [Item 2 - Management's Discussion and Analysis of Financial Condition and Results of Operations](index=27&type=section&id=Item%202%20-%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) This section provides management's perspective on the company's financial condition, operational performance, and future outlook, covering clinical trial progress, manufacturing, funding, and financial analysis [Overview](index=27&type=section&id=Overview) This section introduces Perspective Therapeutics as a radiopharmaceutical development company focused on advanced cancer treatments and its key clinical programs - Perspective Therapeutics is a radiopharmaceutical development company focused on advanced cancer treatments using the alpha-emitting isotope Lead-212 (**212Pb**) and a theranostic approach[100](index=100&type=chunk) - Clinical programs VMT-α-NET (neuroendocrine tumor), VMT01 (melanoma), and PSV359 (solid tumor) are in Phase 1/2a imaging and therapy trials in the U.S[101](index=101&type=chunk) [VMT-α-NET](index=27&type=section&id=VMT-%CE%B1-NET) This section details the clinical progress of VMT-α-NET, targeting SSTR2-expressing neuroendocrine tumors with 212Pb - VMT-α-NET targets SSTR2-expressing neuroendocrine tumors (NETs) with **212Pb**[102](index=102&type=chunk) - Phase 1/2a study in unresectable or metastatic SSTR2-positive NETs reported no dose-limiting toxicities (DLTs), grade 4 or 5 treatment-emergent or serious adverse events (AEs) in Cohorts 1 and 2[103](index=103&type=chunk) - Interim results showed **two unconfirmed responses** and **one confirmed objective response** in Cohort 2 as of January 10, 2025[104](index=104&type=chunk) - As of April 30, 2025, a total of **40 patients** have begun treatment in Cohort 2[108](index=108&type=chunk) [VMT01](index=29&type=section&id=VMT01) This section outlines the clinical development of VMT01, targeting MC1R-overexpressed melanoma cancers with 212Pb, including Fast Track Designation and combination trials - VMT01 targets melanocortin 1 receptor (**MC1R**) overexpressed in melanoma cancers with **212Pb**[111](index=111&type=chunk) - The FDA granted **Fast Track Designation** for the clinical development of [212Pb]VMT01 in September 2024[112](index=112&type=chunk) - A clinical trial collaboration with Bristol Myers Squibb is evaluating [212Pb]VMT01 in combination with nivolumab[113](index=113&type=chunk) - Initial results from the first two dosing cohorts showed no DLTs, no grade 4 or 5 treatment-emergent AEs, and **one unconfirmed objective response** in Cohort 1[114](index=114&type=chunk)[115](index=115&type=chunk) - The Safety Monitoring Committee recommended exploring a lower dose level of **1.5 mCi** for monotherapy and combination with nivolumab, with both cohorts now active and open for enrollment[116](index=116&type=chunk) [PSV359](index=31&type=section&id=PSV359) This section describes PSV359, a novel cyclic peptide targeting FAP-α, and its initial imaging results and clinical trial initiation - PSV359 is a novel cyclic peptide targeting **FAP-α**, a pan-cancer target expressed on tumor stroma cells and some cancer cells[117](index=117&type=chunk) - First-in-human SPECT/CT imaging of [203Pb]PSV359 showed strong tumor uptake, fast renal clearance, low normal organ accumulation, and long tumor retention[118](index=118&type=chunk) - The IND application for PSV359 was filed in December 2024, and a "study may proceed" letter was received from the FDA in Q1 2025; the first patient was treated with [212Pb]PSV359 on April 29, 2025[118](index=118&type=chunk) [Other Pipeline Candidates](index=31&type=section&id=Other%20Pipeline%20Candidates) This section highlights additional pipeline candidates, including in-licensed pre-targeting and PSMA Alpha-PET DoubLET platform technologies - The Company in-licensed Stony Brook University's **CB7-Adma pre-targeting platform** in January 2024, covering global intellectual property rights[119](index=119&type=chunk) - A license agreement with Mayo Clinic for the **PSMA Alpha-PET DoubLET platform technology** for PSMA-expressing cancers was announced in January 2024[120](index=120&type=chunk) [Discovery Program](index=31&type=section&id=Discovery%20Program) This section describes the discovery team's efforts in developing novel constructs for potential first-in-human imaging to de-risk future therapeutic benefits - The discovery team is developing multiple novel constructs for potential first-in-human imaging to de-risk future therapeutic benefits[121](index=121&type=chunk) [Intellectual Property (IP)](index=31&type=section&id=Intellectual%20Property%20(IP)) This section highlights recent patent allowances for proprietary 212Pb generation technology and the VMT-α-NET compound - Two patent applications were allowed by the USPTO: one for proprietary **212Pb generation technology** (expires August 2044) and another for the **VMT-α-NET compound** (expires January 2041)[122](index=122&type=chunk) [Funding Requirements](index=32&type=section&id=Funding%20Requirements) This section discusses the company's anticipated increase in expenses due to advancing clinical programs and its current liquidity position - The Company has incurred recurring losses and expects expenses to increase due to advancing preclinical activities, clinical trials, and potential commercialization of program candidates[123](index=123&type=chunk) - As of March 31, 2025, cash, cash equivalents, and short-term investments of **$211.7 million** are expected to fund planned operations into late 2026[123](index=123&type=chunk) - Management anticipates a significant increase in research and development expenses[123](index=123&type=chunk) [Manufacturing and Supply](index=32&type=section&id=Manufacturing%20and%20Supply) This section outlines the company's strategy for manufacturing and supply chain, including third-party CMOs, internal sites, and key purchase commitments - The Company plans to use a combination of third-party contract manufacturing organizations (CMOs) and its own manufacturing sites for clinical supply and distribution[124](index=124&type=chunk) - A purchase order with the U.S. Department of Energy (DOE) commits the Company to purchasing approximately **$8.4 million** of thorium-228 during 2025 and 2026[125](index=125&type=chunk) - The Company agreed to purchase manufacturing equipment from Comecer SpA for approximately **€49.0 million**[126](index=126&type=chunk) [Facility Acquisitions](index=32&type=section&id=Facility%20Acquisitions) This section details the acquisition of manufacturing facilities in Houston, Chicago, Los Angeles, and Somerset, NJ, to support future production - Buildings were purchased in Houston, Chicago, and Los Angeles in 2024 for future manufacturing[127](index=127&type=chunk) - The radiopharmaceutical manufacturing facility in Somerset, NJ, acquired in 2024, achieved its first shipment and patient dosing in October 2024[128](index=128&type=chunk) [2024 At-the-Market (ATM) Agreement](index=34&type=section&id=2024%20At-the-Market%20(ATM)%20Agreement) This section describes the 2024 ATM Agreement for common stock sales and the proceeds generated from recent issuances - The Company entered into a 2024 ATM Agreement to sell up to **$250.0 million** of common stock through ATM Agents[131](index=131&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[135](index=135&type=chunk) [Brachytherapy Divestiture](index=34&type=section&id=Brachytherapy%20Divestiture) This section details the sale of the Cesium-131 brachytherapy business, including the consideration received - The sale of the Cesium-131 brachytherapy business to GT Medical Technologies, Inc. was completed on April 12, 2024[136](index=136&type=chunk) - Consideration included **279,516 shares** of GT Medical's common stock and future cash royalty payments based on net sales of Cesium-131 brachytherapy seeds and GammaTile Therapy[137](index=137&type=chunk)[138](index=138&type=chunk) [Critical Accounting Policies and Estimates](index=35&type=section&id=Critical%20Accounting%20Policies%20and%20Estimates) This section confirms no material changes to critical accounting policies and estimates since the 2024 Form 10-K - There have been no material changes to the critical accounting policies and estimates disclosed in the 2024 Form 10-K as of March 31, 2025[139](index=139&type=chunk) [Results of Operations](index=35&type=section&id=Results%20of%20Operations) This section analyzes the company's financial performance, including revenues, expenses, and operating loss, for the three months ended March 31, 2025, compared to 2024 - The Company now operates in one segment (Drug Operations) following the brachytherapy divestiture[140](index=140&type=chunk) Consolidated Statements of Operations Summary | Metric (in thousands) | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | Change | | :-------------------- | :-------------------------------- | :-------------------------------- | :----- | | Grant revenue | $342 | $325 | $17 | | Research and development expenses | $14,332 | $7,452 | $6,880 | | General and administrative expenses | $7,842 | $5,878 | $1,964 | | Total operating expenses | $22,174 | $13,330 | $8,844 | | Operating loss | $(21,832) | $(13,005) | $(8,827) | - The increase in research and development expenses was primarily due to expanded development of TAT drug programs, higher personnel costs, and third-party R&D fees[143](index=143&type=chunk) - General and administrative expenses increased primarily due to increased personnel costs, partially offset by decreased professional services fees[149](index=149&type=chunk) [Liquidity and Capital Resources](index=37&type=section&id=Liquidity%20and%20Capital%20Resources) This section discusses the company's cash flows, sources of liquidity, and future funding requirements [Cash Flows](index=37&type=section&id=Cash%20Flows) This section analyzes the company's cash flows from operating, investing, and financing activities Cash Flow Summary | Cash Flow Activity (in thousands) | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :-------------------------------- | :-------------------------------- | :-------------------------------- | | Net cash (used in) provided by operating activities | $(21,582) | $13,848 | | Net cash used in investing activities | $(5,565) | $(47,297) | | Net cash provided by financing activities | $9,973 | $166,328 | | Net (decrease) increase in cash and cash equivalents | $(17,174) | $132,879 | - Net cash used in operating activities in Q1 2025 was primarily due to a net loss of **$18.2 million**, adjusted for non-cash expenses and changes in operating assets and liabilities[151](index=151&type=chunk) - Net cash provided by operating activities in Q1 2024 was primarily due to **$28.0 million** received from an option agreement with Lantheus[152](index=152&type=chunk) [Sources of Liquidity](index=38&type=section&id=Sources%20of%20Liquidity) This section identifies the company's primary sources of capital, including various equity offerings and agreements - The 2024 At-the-Market (ATM) Agreement allows for the sale of up to **$250.0 million** of common stock; **$10.2 million** in gross proceeds were raised on February 18, 2025[157](index=157&type=chunk)[161](index=161&type=chunk) - The May 2024 Registered Offering generated approximately **$80.0 million** in gross proceeds[162](index=162&type=chunk)[163](index=163&type=chunk) - The March 2024 Private Placement with institutional investors generated approximately **$87.4 million** in gross proceeds[165](index=165&type=chunk) - The Lantheus Investment Agreement involved the sale of **5,634,235 shares** to Lantheus, representing **19.99%** ownership[166](index=166&type=chunk) - The January 2024 Public Offering generated approximately **$69.0 million** in gross proceeds[167](index=167&type=chunk)[168](index=168&type=chunk) - Sales under the 2023 ATM Agreement on April 11, 2024, resulted in approximately **$49.5 million** in gross proceeds[170](index=170&type=chunk) [Funding Requirements](index=42&type=section&id=Funding%20Requirements) This section reiterates the company's anticipated increase in expenses and the need for additional capital to fund operations until profitability - Expenses are expected to increase significantly as the Company advances preclinical activities, clinical trials, and potential commercialization of program candidates[171](index=171&type=chunk) - Current cash, cash equivalents, and short-term investments of **$211.7 million** (as of March 31, 2025) are expected to fund operations into late 2026[171](index=171&type=chunk) - Additional capital will be required until profitability is achieved, potentially through equity offerings, debt financings, or strategic alliances, which may dilute existing stockholders[172](index=172&type=chunk)[176](index=176&type=chunk) [Capital expenditures](index=44&type=section&id=Capital%20expenditures) This section addresses management's continuous evaluation of capital deployment for research, development, and operational support - Management continuously evaluates capital deployment for research and development and general and administrative functions to support clinical trials, preclinical activities, and product candidate supply[177](index=177&type=chunk) [Financing activities](index=44&type=section&id=Financing%20activities) This section outlines future capital financing strategies, including equity sales, collaborations, or debt, with potential stockholder dilution - Future capital is expected to be financed through equity sales, strategic collaborations, or debt financing, with anticipated dilution to stockholders[178](index=178&type=chunk) [Other Commitments and Contingencies](index=44&type=section&id=Other%20Commitments%20and%20Contingencies) This section confirms no material changes to other commitments and contingencies beyond those previously disclosed - No material changes to other commitments and contingencies occurred during the three months ended March 31, 2025, beyond those disclosed in Note 10[179](index=179&type=chunk) [Off-Balance Sheet Arrangements](index=44&type=section&id=Off-Balance%20Sheet%20Arrangements) This section states that the company has no off-balance sheet arrangements - The Company has no off-balance sheet arrangements[180](index=180&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, Inc. is exempt from providing quantitative and qualitative disclosures about market risk - The Company is a smaller reporting company and is not required to provide information on quantitative and qualitative disclosures about market risk[181](index=181&type=chunk) [Item 4 - Controls and Procedures](index=45&type=section&id=Item%204%20-%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were effective as of March 31, 2025, with no material changes in internal control over financial reporting during the quarter - The principal executive officer and principal financial officer concluded that the design and operation of disclosure controls and procedures were effective as of March 31, 2025[182](index=182&type=chunk) - There have been no material changes in internal control over financial reporting during the most recent fiscal quarter[183](index=183&type=chunk) [PART II - OTHER INFORMATION](index=46&type=section&id=PART%20II%20-%20OTHER%20INFORMATION) This section covers legal proceedings, risk factors, equity sales, defaults, mine safety, other information, and exhibits [Item 1 - Legal Proceedings](index=46&type=section&id=Item%201%20-%20Legal%20Proceedings) The company is not currently involved in any material legal proceedings and is unaware of any pending or threatened legal actions that could significantly impact its business, operating results, or financial condition - The Company is not currently a party to any material legal proceedings[184](index=184&type=chunk) - No pending or threatened legal proceedings are known that could have a material adverse effect on the business, operating results, or financial condition[184](index=184&type=chunk) [Item 1A - Risk Factors](index=46&type=section&id=Item%201A%20-%20Risk%20Factors) The company refers to the comprehensive risk factors detailed in its 2024 Form 10-K and confirms that no material changes to these risk factors have occurred during the current reporting period - There have been no material changes to the risk factors disclosed in Part I, Item 1A of the 2024 Form 10-K[185](index=185&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) The company reports no unregistered sales of equity securities or use of proceeds for the period - None[186](index=186&type=chunk) [Item 3 - Defaults Upon Senior Securities](index=46&type=section&id=Item%203%20-%20Defaults%20Upon%20Senior%20Securities) The company reports no defaults upon senior securities for the period - None[187](index=187&type=chunk) [Item 4 - Mine Safety Disclosures](index=46&type=section&id=Item%204%20-%20Mine%20Safety%20Disclosures) This item is not applicable to the company's operations - Not applicable[188](index=188&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 any Rule 10b5-1 or non-Rule 10b5-1 trading arrangements during the three months ended March 31, 2025 - No directors or executive officers adopted, modified, or terminated any "Rule 10b5-1 trading arrangement" or "non-Rule 10b5-1 trading arrangement" during the three months ended March 31, 2025[189](index=189&type=chunk) [Item 6 - Exhibits](index=47&type=section&id=Item%206%20-%20Exhibits) This section lists all exhibits filed as part of the Form 10-Q, including various agreements, certificates, and certifications - The exhibits include merger agreements, certificates of incorporation, bylaws, an executive employment agreement, and certifications from the principal executive and financial officers[191](index=191&type=chunk) [Signatures](index=48&type=section&id=Signatures) The report is duly signed on behalf of Perspective Therapeutics, Inc. by its Chief Executive Officer and Chief Financial Officer - The report was signed by Johan (Thijs) Spoor, Chief Executive Officer, and Juan Graham, Chief Financial Officer, on May 12, 2025[193](index=193&type=chunk)
IsoRay, Inc.(ISR) - 2025 Q3 - Quarterly Results
2025-05-12 20:30
[Executive Summary & Recent Highlights](index=1&type=section&id=Executive%20Summary%20%26%20Recent%20Highlights) Perspective Therapeutics reported Q1 2025 results, highlighting clinical trial advancements, U.S. manufacturing expansion, and a strong cash position expected to fund operations into late 2026 [Recent Business Highlights](index=1&type=section&id=Recent%20Business%20Highlights) Perspective Therapeutics announced its Q1 2025 results and provided key business updates, including progress in clinical trials for its next-generation targeted radiopharmaceutical platform, expansion of U.S. manufacturing, and a strong cash position expected to fund operations into late 2026 - First of several clinical updates through mid-2026 accepted for presentation at the 2025 American Society of Clinical Oncology Annual Meeting[3](index=3&type=chunk) - Enrollment ongoing for VMT-α-NET (**40 patients** in Cohort 2 by April 2025) and VMT01 (first patient treated at new monotherapy dose in April 2025, combination in March 2025)[3](index=3&type=chunk) - Achieved first-in-human dosing of PSV359, which targets FAP-α associated with multiple highly prevalent solid tumors[3](index=3&type=chunk) - Advancing U.S. manufacturing capabilities to enable delivery of finished product for growing clinical trial and future commercial demands[3](index=3&type=chunk) Cash, Cash Equivalents and Short-Term Investments | As of Date | Amount (Millions) | | :---------- | :--------------- | | March 31, 2025 | $212 | | Expected Sufficiency | Into late 2026 | [CEO Statement](index=2&type=section&id=CEO%20Statement) CEO Thijs Spoor emphasized the company's commitment to developing novel radiopharmaceuticals for cancer patients, highlighting continued patient recruitment and expansion of U.S. manufacturing capabilities, with further clinical and operational updates expected through mid-2026 - Demonstrating commitment to bringing novel new medicines to patients through continued patient recruitment into trials and expansion of U.S. based manufacturing capabilities[4](index=4&type=chunk) - Focus on three clinical-stage, proprietary potential new medicines based on the next-generation targeted radiopharmaceutical technology platform[4](index=4&type=chunk) - On track to provide updates on more clinical and operational progress through mid-2026 and beyond[4](index=4&type=chunk) [Program Highlights](index=2&type=section&id=Program%20Highlights) This section details the progress and updates on the company's clinical-stage radiopharmaceutical programs, including VMT-α-NET, VMT01, PSV359, and pipeline development [VMT-α-NET](index=2&type=section&id=VMT-%CE%B1-NET) The Phase 1/2a trial for [212Pb]VMT-α-NET in SSTR2-positive neuroendocrine tumors is progressing, with **40 patients** enrolled in Cohort 2 by April 2025. The study received Fast Track Designation, and initial safety data showed no DLTs or severe adverse events, with some anti-tumor activity observed - Company-sponsored Phase 1/2a trial (NCT05636618) of [212Pb]VMT-α-NET in patients with unresectable or metastatic SSTR2-positive neuroendocrine tumors[5](index=5&type=chunk) - Received Fast Track Designation from the U.S. Food and Drug Administration (FDA)[5](index=5&type=chunk) - Cohort 2 reopened for enrollment in August 2024, with a total of **40 patients** having begun treatment as of April 30, 2025[7](index=7&type=chunk)[10](index=10&type=chunk) - Safety findings (as of Jan 10, 2025): **No DLTs**, Grade 4 or 5 treatment emergent adverse events (TEAEs), or serious adverse events (SAEs) reported. Hematologic AEs were Grades 1 and 2. No treatment discontinuations due to AEs[10](index=10&type=chunk) - Anti-tumor activity (as of Jan 10, 2025): One confirmed response and two unconfirmed responses (RECIST v1.1) in Cohort 2. Eight of nine patients in Cohorts 1 and 2 remained on study without progressive disease[10](index=10&type=chunk) - Data on [212Pb]VMT-α-NET accepted for an oral presentation at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting on May 30, 2025[10](index=10&type=chunk) [VMT01](index=4&type=section&id=VMT01) VMT01, an MC1R-targeted RPT for melanoma, is undergoing a Phase 1/2a study. Following initial dosing, the SMC recommended exploring a lower dose (**1.5 mCi**) as monotherapy and in combination with nivolumab, with first patients treated in March/April 2025. Initial safety data showed no DLTs or severe adverse events, and some patients achieved objective response or stable disease - VMT01 is an MC1R-targeted RPT that can be radiolabeled with either 203Pb for patient selection/dosimetry or 212Pb for alpha particle therapy[9](index=9&type=chunk) - Multi-center, open-label dose finding, dose expansion study (NCT05655312) in previously treated patients with histologically confirmed melanoma and MC1R-positive imaging scans[11](index=11&type=chunk) - SMC recommended exploring a lower dose level of **1.5 mCi** per dose, both as monotherapy and in combination with the anti-PD-1 antibody nivolumab[13](index=13&type=chunk) - First patients in the combination and monotherapy cohorts received their initial treatments in March and April 2025, respectively[13](index=13&type=chunk) - Safety findings (as of Sep 4, 2024): **No DLTs** observed, no adverse events led to treatment discontinuation, TEAEs were mostly Grades 1 and 2, and no renal toxicities reported[14](index=14&type=chunk) - Anti-tumor activity (as of Sep 4, 2024): One patient in Cohort 1 (**3.0 mCi**) experienced an unconfirmed RECIST v1.1 objective response, and two patients experienced stable disease. Cohort 2 (**5.0 mCi**) patients progressed[14](index=14&type=chunk) - Data on [212Pb]VMT01 accepted as a poster presentation at the 2025 ASCO Annual Meeting on June 2, 2025[15](index=15&type=chunk) [PSV359](index=5&type=section&id=PSV359) PSV359 is designed to target FAP-α expressing solid tumors with the alpha-emitting isotope 212Pb. The first patient has been treated with [212Pb]PSV359, and preclinical/human imaging data suggest improved target engagement and reduced retention in healthy tissues - PSV359 is designed to target and deliver 212Pb to tumor sites expressing fibroblast activation protein-α (FAP-α), associated with multiple highly prevalent solid tumors[16](index=16&type=chunk) - The targeting moiety can also be radiolabeled with 203Pb or 68Ga (PSV377) to detect FAP-α expression in individual patients[16](index=16&type=chunk) - First patient treated with [212Pb]PSV359 disclosed on April 29, 2025, with activation activities underway for additional sites[17](index=17&type=chunk) [Clinical Pipeline Expansion](index=5&type=section&id=Adding%20to%20the%20clinical%20pipeline) Perspective Therapeutics' discovery team is actively preparing multiple novel constructs for potential first-in-human imaging, serving as a de-risking step for future therapeutic development, with plans for pre-IND filing activities once criteria are met - Discovery team is preparing multiple additional novel constructs for potential first-in-human imaging as a de-risking step for potential therapeutic benefit[18](index=18&type=chunk) - Plans to proceed with pre-IND filing activities if and when those constructs meet criteria for further development[18](index=18&type=chunk) [Other Business Developments](index=5&type=section&id=Other%20Business%20Highlights) This section provides updates on the company's operational infrastructure, including manufacturing expansion, isotope procurement, and intellectual property protection [Manufacturing Capabilities](index=5&type=section&id=Delivering%20ready-to-administer%20radiopharmaceuticals%20for%20clinical%20trial%20and%20commercial%20operations) Perspective Therapeutics is expanding its U.S. manufacturing network to support clinical trials and future commercial operations, utilizing proprietary generator technology for 212Pb and third-party sources for 203Pb. The company has two operational sites and is building three more, with no material tariff impacts expected in 2025 - Establishing a regional network of drug-product finishing facilities to support current clinical activities and prepare for future commercial operations[19](index=19&type=chunk) - Utilizes both 203Pb (sourced from third-party cyclotron production) and 212Pb (produced in-house using proprietary generator technology) to manufacture ready-to-administer radiopharmaceuticals[19](index=19&type=chunk) - Currently has **two U.S. manufacturing sites** and is building out **three additional U.S. sites** in Houston, Chicago, and Los Angeles metropolitan areas to support growing clinical trial and future commercial demands[20](index=20&type=chunk)[25](index=25&type=chunk) - **No material incremental tariff-related cost impacts** expected in 2025 based on initial analysis of recently announced tariffs[20](index=20&type=chunk) - Ordered manufacturing equipment in 3Q 2024, including isotope processing hot cells and production suites, with production commenced[21](index=21&type=chunk) - Working towards expanding capacity in the second manufacturing facility in Somerset, New Jersey, acquired in 1Q 2024, to meet demand in the Northeastern U.S.[25](index=25&type=chunk) [Isotope Supply Chain](index=6&type=section&id=Isotope%20supply) The company's therapeutic isotope, 212Pb, is derived from 228Th, which is procured from the U.S. Department of Energy (DOE). A new purchase order was entered in May 2025 for additional 228Th for 2025 and 2026, ensuring sufficient supply for clinical trials - Therapeutic isotope 212Pb naturally decays from 224Ra, which in turn naturally decays from 228Th[22](index=22&type=chunk) - Procures 228Th from the U.S. Department of Energy (DOE)[22](index=22&type=chunk) - Entered into a purchase order with the DOE in May 2025 to purchase additional 228Th during 2025 and 2026, expected to be sufficient to support clinical trials[22](index=22&type=chunk)[23](index=23&type=chunk) [Patent Portfolio](index=6&type=section&id=Patent%20portfolio) Perspective Therapeutics strengthened its patent portfolio in Q1 2025 with the allowance of two key patent applications by the USPTO: one for its proprietary 212Pb generation technology (expiring August 2044) and another for the VMT-α-NET compound (expiring January 2041) - Patent portfolio further strengthened in 1Q 2025 by the allowance of two patent applications on key assets by the U.S. Patent and Trademark Office (USPTO)[24](index=24&type=chunk) - First patent application pertains to wholly owned, proprietary technology for generation of 212Pb at scale, expiring in **August 2044**[24](index=24&type=chunk) - Second patent application pertains to the VMT-α-NET compound (exclusive license from the University of Iowa), expiring in **January 2041**[24](index=24&type=chunk) [Financial Performance (Q1 2025)](index=7&type=section&id=First%20Quarter%202025%20Financial%20Summary) This section provides a detailed overview of Perspective Therapeutics' financial results for Q1 2025, including cash position, equity, revenue, expenses, net loss, and key balance sheet and income statement figures [Cash Position & Funding](index=7&type=section&id=Cash%2C%20cash%20equivalents%2C%20and%20short-term%20investments) The company's cash, cash equivalents, and short-term investments decreased to **$212 million** as of March 31, 2025, from **$227 million** at December 31, 2024. This funding is expected to be sufficient into late 2026, supporting clinical programs and manufacturing expansion Cash, Cash Equivalents, and Short-Term Investments | Metric | March 31, 2025 (Millions) | December 31, 2024 (Millions) | | :-------------------------------- | :------------------------ | :------------------------- | | Cash, cash equivalents, and short-term investments | ~$212 | ~$227 | - Expected to have sufficient funding into **late 2026** to advance current clinical programs, progress multiple pre-IND assets, and build out regional manufacturing sites[26](index=26&type=chunk) [Equity and Capital Structure](index=7&type=section&id=2024%20ATM%20Agreement) In Q1 2025, the company sold **3.38 million** common shares under its 2024 ATM Agreement, generating **$10.2 million** in gross proceeds. As of March 31, 2025, the company had approximately **74.1 million** common shares outstanding, along with warrants and pre-funded warrants - Sold **3,379,377 shares** of common stock under the 2024 ATM Agreement in February 2025[27](index=27&type=chunk) 2024 ATM Agreement Share Sales | Metric | Value | | :---------------- | :------------ | | Average Price per Share | ~$3.02 | | Gross Proceeds | ~$10.2 million | Outstanding Equity as of March 31, 2025 | Instrument | Quantity (Shares) | | :----------------------- | :---------------- | | Common Stock | 74.1 million | | Warrants and Options | 10.6 million | | Pre-funded Warrants | 146,425 | [Segment Reporting Change](index=7&type=section&id=Segment%20Reporting%20Change) Following the divestiture of its brachytherapy segment in April 2024, Perspective Therapeutics has reclassified these operations as discontinued in its financial statements, with subsequent discussions pertaining to continuing operations - Divestiture of the entire brachytherapy segment to GT Medical in **April 2024**[29](index=29&type=chunk) - Operations of the brachytherapy segment have been classified as discontinued operations in financial statements[29](index=29&type=chunk) [Grant Revenue](index=7&type=section&id=Grant%20revenue) Grant revenue for Q1 2025 remained stable at approximately **$0.3 million**, primarily derived from work with the National Institutes of Health Grant Revenue (Q1 2025 vs Q1 2024) | Period | Grant Revenue (Millions) | | :------------------- | :---------------------- | | Q1 2025 | $0.3 | | Q1 2024 | $0.3 | - Grant revenue is derived from work with the National Institutes of Health[30](index=30&type=chunk) [Operating Expenses](index=7&type=section&id=Operating%20expenses) Total operating expenses increased by **66%** year-over-year to **$22.2 million** in Q1 2025, driven by a **92%** increase in R&D expenses to **$14.3 million** (supporting clinical trials and manufacturing expansion) and a **33%** increase in G&A expenses to **$7.8 million** (due to higher personnel costs) Operating Expenses (Q1 2025 vs Q1 2024) | Expense Category | Q1 2025 (Millions) | Q1 2024 (Millions) | YoY Change | | :------------------------ | :----------------- | :----------------- | :--------- | | Research and development | $14.3 | $7.5 | +92% | | General and administrative | $7.8 | $5.9 | +33% | | **Total Operating Expenses** | **$22.2** | **$13.3** | **+66%** | - Increase in R&D expenses supports clinical trials for clinical development assets, manufacturing and CMC activities, and discovery efforts[31](index=31&type=chunk) - Increase in general and administrative expenses primarily due to increased personnel costs, partially offset by decreased fees for professional services[32](index=32&type=chunk) [Net Loss and EPS](index=8&type=section&id=Net%20loss) The net loss for Q1 2025 increased to **$18.2 million**, or **$0.25** loss per basic and diluted share, compared to a net loss of **$12.3 million**, or **$0.25** per share, in Q1 2024 (adjusted for reverse stock split). The period included a **$2.3 million** net benefit from interest income and other expense, and **$1.4 million** in deferred income Net Loss and EPS (Q1 2025 vs Q1 2024) | Metric | Q1 2025 (Millions) | Q1 2024 (Millions) | | :-------------------------------- | :----------------- | :----------------- | | Net Loss | $18.2 | $12.3 | | Basic and Diluted Loss per Share | $0.25 | $0.25 | - Net benefit of **$2.3 million** in net interest income and other expense during the quarter[34](index=34&type=chunk) - Recognized **$1.4 million** of Deferred Income, which was received in 2024[34](index=34&type=chunk) [Condensed Consolidated Balance Sheets](index=12&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) The condensed consolidated balance sheet shows total assets decreased from **$341.1 million** at December 31, 2024, to **$329.3 million** at March 31, 2025. Current assets saw a decrease, primarily in cash and cash equivalents, while property and equipment, net, increased. Total liabilities also decreased from **$50.4 million** to **$44.7 million** Key Balance Sheet Data (March 31, 2025 vs. December 31, 2024) | Metric | March 31, 2025 (Thousands) | December 31, 2024 (Thousands) | | :-------------------------------- | :------------------------- | :-------------------------- | | Cash and cash equivalents | $44,406 | $61,580 | | Short-term investments | $167,296 | $165,336 | | Total current assets | $215,742 | $231,160 | | Property and equipment, net | $61,247 | $57,321 | | Total assets | $329,349 | $341,101 | | Total current liabilities | $12,679 | $18,230 | | Total liabilities | $44,704 | $50,433 | | Total stockholders' equity | $284,645 | $290,668 | [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=13&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) The condensed consolidated statements of operations show a net loss of **$18.2 million** for Q1 2025, an increase from **$12.3 million** in Q1 2024. This was primarily driven by higher R&D and G&A expenses, partially offset by increased interest income and other non-operating income Key Income Statement Data (Three Months Ended March 31, 2025 vs. 2024) | Metric | 2025 (Thousands) | 2024 (Thousands) | | :-------------------------------- | :--------------- | :--------------- | | Grant revenue | $342 | $325 | | Research and development | $14,332 | $7,452 | | General and administrative | $7,842 | $5,878 | | Total operating expenses | $22,174 | $13,330 | | Operating loss | $(21,832) | $(13,005) | | Total non-operating income, net | $3,655 | $1,180 | | Net loss from continuing operations | $(18,177) | $(11,825) | | Net loss from discontinued operations | $- | $(459) | | Net loss | $(18,177) | $(12,284) | | Basic and diluted loss per share | $(0.25) | $(0.25) | [Company Overview & Forward-Looking Statements](index=8&type=section&id=About%20Perspective%20Therapeutics%2C%20Inc.%20and%20Safe%20Harbor%20Statement) This section provides an introduction to Perspective Therapeutics' mission and technology, along with a cautionary statement regarding forward-looking information and associated risks [About Perspective Therapeutics, Inc.](index=8&type=section&id=About%20Perspective%20Therapeutics%2C%20Inc.) Perspective Therapeutics is a radiopharmaceutical development company focused on pioneering advanced cancer treatments using its proprietary technology, which delivers the alpha-emitting isotope 212Pb to cancer cells. The company employs a 'theranostic' approach, combining imaging diagnostics with targeted therapy to personalize treatment and optimize patient outcomes - Radiopharmaceutical development company pioneering advanced treatments for cancers throughout the body[35](index=35&type=chunk) - Proprietary technology utilizes the alpha-emitting isotope 212Pb to deliver powerful radiation specifically to cancer cells via specialized targeting moieties[35](index=35&type=chunk) - Developing complementary imaging diagnostics that incorporate the same targeting moieties, enabling a 'theranostic' approach to personalize treatment and optimize patient outcomes[35](index=35&type=chunk) - Melanoma (VMT01), neuroendocrine tumor (VMT-α-NET), and solid tumor (PSV359) programs are in Phase 1/2a imaging and therapy trials in the U.S.[36](index=36&type=chunk) [Safe Harbor Statement](index=8&type=section&id=Safe%20Harbor%20Statement) This section contains forward-looking statements regarding the company's plans, intentions, and expectations, including clinical trial progress, manufacturing expansion, and financial outlook. It also outlines significant risks and uncertainties that could cause actual results to differ materially from these statements, such as regulatory delays, clinical trial outcomes, manufacturing issues, and funding needs - Contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995, covering plans, intentions, and expectations[37](index=37&type=chunk)[38](index=38&type=chunk)[39](index=39&type=chunk) - Highlights risks and uncertainties that could cause actual results to differ materially, including regulatory approval delays, clinical trial outcomes, manufacturing and supply chain disruptions, and the need for additional financing[40](index=40&type=chunk) - The Company undertakes no obligation to publicly update or revise any forward-looking statements unless required by law[41](index=41&type=chunk)