IsoRay, Inc.(ISR) - 2025 Q4 - Annual Report
IsoRay, Inc.IsoRay, Inc.(US:ISR)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)