[DISCLOSURE REGARDING FORWARD-LOOKING STATEMENTS](index=4&type=section&id=DISCLOSURE%20REGARDING%20FORWARD-LOOKING%20STATEMENTS) This section outlines the nature of forward-looking statements, which are subject to risks and uncertainties that could cause actual results to differ materially - Forward-looking statements are based on current beliefs, expectations, or assumptions about the future of the business, plans, strategies, and operational results, rather than historical facts[7](index=7&type=chunk) - These statements are subject to known and unknown risks and uncertainties, as well as assumptions that could cause actual results to differ materially from those projected[7](index=7&type=chunk)[9](index=9&type=chunk) - Key areas covered by forward-looking statements include contingent payments, R&D costs, foreign currency risk, fair value estimates, competition, patent terms, corporate strategy, liquidity, Nasdaq listing, business growth drivers, product candidate development timelines, legal proceedings, and the impact of global events and healthcare reforms[8](index=8&type=chunk)[11](index=11&type=chunk) [PART I — FINANCIAL INFORMATION](index=7&type=section&id=PART%20I%20FINANCIAL%20INFORMATION) This part presents the company's unaudited interim financial statements and management's discussion and analysis of financial condition and results of operations [Item 1. Condensed Consolidated Financial Statements (unaudited)](index=7&type=section&id=Item%201.%20Condensed%20Consolidated%20Financial%20Statements%20(unaudited)) This section presents the unaudited condensed consolidated financial statements, providing a snapshot of the company's financial position and performance [Condensed Consolidated Balance Sheets](index=7&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) This section details the company's assets, liabilities, and shareholders' deficit at the end of the reporting period **Condensed Consolidated Balance Sheet Highlights** | Metric | June 30, 2025 | December 31, 2024 | Change | | :--- | :--- | :--- | :--- | | Cash | $4,510,119 | $13,291,167 | $(8,781,048) | | Total current assets | $9,509,496 | $18,911,456 | $(9,401,960) | | Total current liabilities | $9,824,087 | $2,218,425 | $7,605,662 | | Total liabilities | $9,892,074 | $2,423,280 | $7,468,794 | | Total shareholders' (deficit) equity | $(382,578) | $16,488,176 | $(16,870,754) | | Accumulated deficit | $(108,152,005) | $(90,687,073) | $(17,464,932) | [Condensed Consolidated Statements of Operations](index=8&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) This section presents the company's operating expenses and net loss for the reported interim periods **Condensed Consolidated Statements of Operations Highlights** | Metric | 3 Months Ended June 30, 2025 | 3 Months Ended June 30, 2024 | 6 Months Ended June 30, 2025 | 6 Months Ended June 30, 2024 | | :--- | :--- | :--- | :--- | :--- | | Research and development | $8,749,784 | $1,625,821 | $14,214,034 | $3,749,599 | | General and administrative | $1,434,877 | $1,087,885 | $3,430,723 | $2,640,758 | | Total operating expenses | $10,184,661 | $2,713,706 | $17,644,757 | $6,390,357 | | Net loss | $(10,117,029) | $(2,623,657) | $(17,464,932) | $(6,258,745) | | Net loss per share (basic & diluted) | $(0.29) | $(0.13) | $(0.50) | $(0.32) | - Research and development expenses increased significantly by **438%** for the three months ended June 30, 2025, and **284%** for the six months ended June 30, 2025, compared to the prior year periods[17](index=17&type=chunk) [Condensed Consolidated Statements of Changes in Shareholders' Deficit](index=9&type=section&id=Condensed%20Consolidated%20Statements%20of%20Changes%20in%20Shareholders'%20Deficit) This section details the changes in the components of shareholders' deficit during the reporting period **Changes in Shareholders' Deficit (January 1, 2025 to June 30, 2025)** | Item | Balance, Jan 1, 2025 | Share-based compensation expense | Re-measurement of liability-classified CAD stock options | Net loss | Balance, June 30, 2025 | | :--- | :--- | :--- | :--- | :--- | :--- | | Additional Paid-in Capital | $107,546,433 | $457,310 | $136,868 | — | $108,140,611 | | Accumulated Deficit | $(90,687,073) | — | — | $(17,464,932) | $(108,152,005) | | Total Shareholders' (Deficit) Equity | $16,488,176 | $457,310 | $136,868 | $(17,464,932) | $(382,578) | [Condensed Consolidated Statements of Cash Flows](index=11&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) This section summarizes the cash inflows and outflows from operating, investing, and financing activities **Condensed Consolidated Statements of Cash Flows Highlights** | Cash Flow Activity | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--- | :--- | :--- | | Net Loss | $(17,464,932) | $(6,258,745) | | Net cash used in operating activities | $(8,781,048) | $(11,795,957) | | Net cash provided by financing activities | — | $190,274 | | Net decrease in cash | $(8,781,048) | $(11,605,683) | | Cash at end of period | $4,510,119 | $992,463 | - Cash used in operating activities decreased by **$3.0 million** for the six months ended June 30, 2025, compared to the same period in 2024, despite a higher net loss, due to favorable changes in operating assets and liabilities, particularly increases in accrued liabilities and accounts payable[24](index=24&type=chunk)[148](index=148&type=chunk)[149](index=149&type=chunk) [Notes to Unaudited Condensed Consolidated Financial Statements](index=12&type=section&id=Notes%20to%20Unaudited%20Condensed%20Consolidated%20Financial%20Statements) This section provides detailed disclosures and explanations of the amounts presented in the financial statements [1. DESCRIPTION OF BUSINESS](index=12&type=section&id=1.%20DESCRIPTION%20OF%20BUSINESS) This note describes the company's focus on developing therapies for neurodegenerative diseases and its current financial challenges - ProMIS Neurosciences Inc. develops antibody therapies and therapeutic vaccines for neurodegenerative diseases like Alzheimer's, MSA, and ALS, focusing on misfolded proteins[27](index=27&type=chunk) - The company's lead product candidates include PMN310 for AD, PMN267 for ALS, and PMN442 for MSA and Parkinson's disease, all designed to selectively target toxic misfolded proteins[28](index=28&type=chunk) - The company's success is dependent on obtaining regulatory approvals, marketing products, and securing additional financing, with management expressing **substantial doubt about its ability to continue as a going concern** due to ongoing losses and funding needs[30](index=30&type=chunk)[31](index=31&type=chunk) [2. BASIS OF PRESENTATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES](index=13&type=section&id=2.%20BASIS%20OF%20PRESENTATION%20AND%20SUMMARY%20OF%20SIGNIFICANT%20ACCOUNTING%20POLICIES) This note outlines the accounting principles and policies used in preparing the financial statements - The financial statements are prepared in conformity with U.S. GAAP and include all normal recurring adjustments necessary for fair presentation[35](index=35&type=chunk)[36](index=36&type=chunk) - The company operates as a single operating segment (life science) and consolidates its wholly-owned subsidiary, ProMIS USA[38](index=38&type=chunk)[40](index=40&type=chunk) - As an Emerging Growth Company, ProMIS has elected to use the extended transition period for complying with new or revised accounting standards[41](index=41&type=chunk) [3. FAIR VALUE MEASUREMENTS](index=17&type=section&id=3.%20FAIR%20VALUE%20MEASUREMENTS) This note provides details on the fair value hierarchy for financial assets and liabilities **Fair Value Measurements (June 30, 2025)** | Category | Level 1 | Level 2 | Level 3 | Total | | :--- | :--- | :--- | :--- | :--- | | Short-term investments | $33,051 | $— | $— | $33,051 | | Share-based compensation liability | $— | $— | $62,395 | $62,395 | | Warrant liability | $— | $— | $5,592 | $5,592 | **Fair Value Measurements (December 31, 2024)** | Category | Level 1 | Level 2 | Level 3 | Total | | :--- | :--- | :--- | :--- | :--- | | Short-term investments | $33,051 | $— | $— | $33,051 | | Share-based compensation liability | $— | $— | $199,263 | $199,263 | | Warrant liability | $— | $— | $5,592 | $5,592 | - Share-based compensation liability decreased from **$199,263** at December 31, 2024, to **$62,395** at June 30, 2025[45](index=45&type=chunk) [4. PREPAID EXPENSES AND OTHER CURRENT ASSETS](index=17&type=section&id=4.%20PREPAID%20EXPENSES%20AND%20OTHER%20CURRENT%20ASSETS) This note details the components of prepaid expenses and other current assets **Prepaid Expenses and Other Current Assets** | Item | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Upfront research payments | $4,759,310 | $5,087,692 | | Accrued interest and other receivables | $29,484 | $78,034 | | Insurance | $89,136 | $335,976 | | License fees | $75,352 | $38,255 | | Miscellaneous | $13,044 | $47,281 | | **Total** | **$4,966,326** | **$5,587,238** | [5. ACCRUED LIABILITIES AND ACCOUNTS PAYABLE](index=17&type=section&id=5.%20ACCRUED%20LIABILITIES%20AND%20ACCOUNTS%20PAYABLE) This note details the components of accrued liabilities **Accrued Liabilities** | Item | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Legal | $33,931 | $44,610 | | Accounting | $138,096 | $95,182 | | Research and development | $6,564,059 | $223,559 | | Severance | $303,546 | $38,328 | | Other | $4,276 | $79,283 | | **Total** | **$7,043,908** | **$480,962** | - Research and development accrued liabilities increased by over **$6.3 million** from December 31, 2024, to June 30, 2025[47](index=47&type=chunk) [6. EQUITY](index=19&type=section&id=6.%20EQUITY) This note describes the company's equity structure, including common shares, warrants, and recent financing activities **Common Shares Reserved for Future Issuance** | Item | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Warrants | 57,141,386 | 57,141,386 | | Options issued and outstanding | 3,760,859 | 3,574,453 | | Deferred Share Units granted | 1,061 | 1,061 | | Common Shares available for grant | 2,776,979 | 2,963,385 | | **Total** | **63,680,285** | **63,680,285** | - In July 2024, the company completed a private placement (PIPE) raising **$30.3 million** gross proceeds, involving common share units and pre-funded units with various warrants[53](index=53&type=chunk)[54](index=54&type=chunk) - The Tranche A and B Warrants from the July 2024 PIPE were initially classified as liabilities due to shareholder approval requirements, then reclassified to equity after approval on October 23, 2024, resulting in a **$22.5 million** change in fair value recorded as other income (expense)[57](index=57&type=chunk)[59](index=59&type=chunk) [7. WARRANTS](index=23&type=section&id=7.%20WARRANTS) This note provides a summary of the outstanding common share warrants **Outstanding Common Share Warrants (June 30, 2025)** | Exercise Price ($) | Number of Warrants | Expiry Date | | :--- | :--- | :--- | | C$12.00 | 279,613 | November 2025 | | US$2.02 | 14,128,696 | January 2026 | | US$12.60 | 524,088 | August 2026 | | US$9.60 | 146,744 | August 2026 | | US$2.02 | 14,128,696 | January 2027 | | US$7.50 | 345,938 | April 2028 | | US$6.10 | 69,188 | April 2028 | | US$1.75 | 11,227,714 | February 2029 | | US$2.50 | 14,128,696 | July 2029 | | US$0.01 | 2,162,013 | None | | **Total** | **57,141,386** | | - No warrant exercises occurred during the three or six months ended June 30, 2025[64](index=64&type=chunk) [8. SHARE-BASED COMPENSATION](index=23&type=section&id=8.%20SHARE-BASED%20COMPENSATION) This note details the company's stock option plans and related compensation expenses - The 2025 Stock Option Plan replaced the 2015 plan, reserving **2,946,719 Common Shares** for issuance, with **2,776,979 options** available for grant as of June 30, 2025[65](index=65&type=chunk) **Share-based Compensation Expense** | Expense Category | 3 Months Ended June 30, 2025 | 3 Months Ended June 30, 2024 | 6 Months Ended June 30, 2025 | 6 Months Ended June 30, 2024 | | :--- | :--- | :--- | :--- | :--- | | Research and development | $37,883 | $3,813 | $75,557 | $7,625 | | General and administrative | $174,132 | $14,186 | $381,753 | $73,958 | | **Total** | **$212,015** | **$17,999** | **$457,310** | **$81,583** | - Total share-based compensation expense significantly increased to **$457,310** for the six months ended June 30, 2025, from **$81,583** in the prior year, with a substantial portion allocated to general and administrative expenses[72](index=72&type=chunk) [9. SEGMENT REPORTING](index=27&type=section&id=9.%20SEGMENT%20REPORTING) This note describes the company's single operating segment and related financial information - The company has one reportable segment: life science, which involves the development of clinical and preclinical product candidates[73](index=73&type=chunk) - The CODM (Chief Executive Officer) assesses segment performance based on net income (loss) and cash forecast models, as the company has not generated any product revenue to date[75](index=75&type=chunk)[76](index=76&type=chunk) **Segment Operating Expenses and Net Loss** | Expense Category | 3 Months Ended June 30, 2025 | 3 Months Ended June 30, 2024 | 6 Months Ended June 30, 2025 | 6 Months Ended June 30, 2024 | | :--- | :--- | :--- | :--- | :--- | | PMN310 development program costs | $8,050,610 | $1,073,864 | $12,776,951 | $2,623,174 | | Total Operating Expenses | $10,184,661 | $2,713,706 | $17,644,757 | $6,390,357 | | Net Loss | $10,117,029 | $2,623,657 | $17,464,932 | $6,258,745 | [10. RELATED PARTY TRANSACTIONS](index=28&type=section&id=10.%20RELATED%20PARTY%20TRANSACTIONS) This note discloses transactions with related parties, including a collaborative research agreement - The company has a collaborative research agreement (CRA) with UBC and Vancouver Coastal Health Authority, extended to February 2026, with aggregate funding increased to **C$5,830,000**[80](index=80&type=chunk) **Related Party Transaction Costs (UBC CRA)** | Item | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--- | :--- | :--- | | Cash payments | $283,600 | $149,160 | | Incurred costs | $283,307 | $294,333 | [11. COMMITMENTS AND CONTINGENCIES](index=28&type=section&id=11.%20COMMITMENTS%20AND%20CONTINGENCIES) This note outlines the company's contractual commitments and potential contingencies - Compensation under research, development, and license agreements typically includes upfront fees, milestone payments, and royalty payments, with no accruals for milestone or royalty amounts required as of June 30, 2025[81](index=81&type=chunk)[82](index=82&type=chunk)[83](index=83&type=chunk) - The company has an ongoing license agreement with UBC, requiring an annual license fee of **C$25,000**, and indemnification agreements with its directors and officers[85](index=85&type=chunk)[86](index=86&type=chunk) [12. NET LOSS PER SHARE](index=30&type=section&id=12.%20NET%20LOSS%20PER%20SHARE) This note explains the calculation of basic and diluted net loss per share **Net Loss Per Share (Basic and Diluted)** | Metric | 3 Months Ended June 30, 2025 | 3 Months Ended June 30, 2024 | 6 Months Ended June 30, 2025 | 6 Months Ended June 30, 2024 | | :--- | :--- | :--- | :--- | :--- | | Net loss | $(10,117,029) | $(2,623,657) | $(17,464,932) | $(6,258,745) | | Weighted-average shares outstanding (basic and diluted) | 34,851,203 | 19,770,739 | 34,851,203 | 19,544,908 | | Net loss per share (basic and diluted) | $(0.29) | $(0.13) | $(0.50) | $(0.32) | - Stock options and warrants were excluded from diluted net loss per share calculation as their effect would be anti-dilutive[87](index=87&type=chunk)[88](index=88&type=chunk) **Potentially Dilutive Common Shares Equivalents Excluded** | Item | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--- | :--- | :--- | | Options issued and outstanding | 3,760,859 | 1,087,493 | | Warrants | 54,979,373 | 12,793,270 | | Series 2 Convertible Preferred Shares | — | 1,166,667 | | Deferred Share Units | 1,061 | 1,061 | | **Total** | **58,741,293** | **15,048,491** | [13. SUBSEQUENT EVENTS](index=31&type=section&id=13.%20SUBSEQUENT%20EVENTS) This note describes significant events that occurred after the balance sheet date - On July 21, 2025, the company terminated its At-the-Market (ATM) Offering Agreement[89](index=89&type=chunk) - In July 2025, the company received aggregate gross proceeds of **$21.6 million** from a registered direct offering ($0.8 million), two private placements ($2.4 million and $3.0 million), and discounted warrant exercises ($15.9 million)[90](index=90&type=chunk)[91](index=91&type=chunk)[94](index=94&type=chunk)[95](index=95&type=chunk) - The July 22, 2025, and July 29, 2025, PIPE offerings involved the sale of warrants to purchase **12,616,821** and **15,616,360** Common Shares, respectively, both with an exercise price of **$1.25 per share**[91](index=91&type=chunk)[93](index=93&type=chunk)[94](index=94&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=34&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) This section provides management's perspective on the company's financial condition, results of operations, and liquidity, emphasizing significant operating losses and the need for additional funding [Overview](index=34&type=section&id=Overview) This section provides a high-level summary of the company's business, financial performance, and going concern uncertainty - ProMIS is developing antibody therapies for neurodegenerative diseases (AD, MSA, ALS) by selectively targeting misfolded toxic proteins using its patented technology platform[97](index=97&type=chunk)[98](index=98&type=chunk) - The company has incurred significant operating losses since inception, with a net loss of **$17.5 million** for the six months ended June 30, 2025, and an accumulated deficit of **$108.2 million**[100](index=100&type=chunk) - Management believes there is **substantial doubt** about the company's ability to continue as a going concern, requiring significant additional funding to support operations and growth strategy[102](index=102&type=chunk)[104](index=104&type=chunk) [Program Updates](index=36&type=section&id=Program%20Updates) This section details the progress of the company's key therapeutic development programs - PMN310, the lead product candidate for Alzheimer's disease, is in a Phase 1b clinical trial (PRECISE-AD), with all of Cohort 1 and over **50% of Cohort 2 enrolled**, and no cases of ARIA observed to date[105](index=105&type=chunk)[106](index=106&type=chunk)[108](index=108&type=chunk) - PMN310 received **FDA Fast Track Designation** on July 21, 2025, recognizing its potential to address an unmet medical need in AD[108](index=108&type=chunk) - Six-month interim data for PMN310 is anticipated in **Q2 2026**, with topline results expected in **Q4 2026**[108](index=108&type=chunk) - PMN267 (ALS) and PMN442 (MSA) have been humanized and are ready to progress to IND-enabling studies, contingent on sufficient resources[110](index=110&type=chunk)[112](index=112&type=chunk) [Recent Corporate Highlights](index=38&type=section&id=Recent%20Corporate%20Highlights) This section summarizes key corporate achievements and financing activities - PMN310 was granted **Fast Track Designation** by the FDA on July 21, 2025[118](index=118&type=chunk) - As of August 13, 2025, over **50% of planned patient enrollment** for the PMN310 trial has been achieved, with no observed cases of ARIA[118](index=118&type=chunk) - In July 2025, the company received aggregate gross proceeds of **$21.6 million** across multiple transactions, including a registered direct offering, private placements, and discounted warrant exercises[118](index=118&type=chunk) [Components of Operating Results](index=38&type=section&id=Components%20of%20Operating%20Results) This section breaks down the key components of the company's operating results [Revenue](index=38&type=section&id=Revenue) This subsection clarifies the company's current revenue status - The company has not generated any revenue since its inception and does not expect to generate significant revenue from product sales in the near future[116](index=116&type=chunk) [Operating Expenses](index=38&type=section&id=Operating%20Expenses) This subsection details the primary categories of operating expenses [Research and Development Expenses](index=38&type=section&id=Research%20and%20Development%20Expenses) This section describes the costs associated with the company's research and development activities - Research and development expenses primarily consist of employee-related expenses, external research and development expenses (e.g., CROs, consultants), costs for acquiring, developing, and manufacturing clinical study materials, and costs associated with preclinical and clinical activities[117](index=117&type=chunk)[126](index=126&type=chunk) - These expenses are expected to increase substantially as the company advances its product candidates through clinical development and seeks regulatory approvals[121](index=121&type=chunk) [General and Administrative Expenses](index=40&type=section&id=General%20and%20Administrative%20Expenses) This section describes the costs associated with administrative and corporate functions - General and administrative expenses primarily include personnel costs (salary, bonus, benefits, share-based compensation), intellectual property development and protection costs, professional service fees, and other general overhead and facility costs[123](index=123&type=chunk) - These expenses are expected to increase substantially to support business growth and ongoing research and development activities[123](index=123&type=chunk) [Other (Expense) Income](index=40&type=section&id=Other%20(Expense)%20Income) This section describes other non-operating income and expenses - Other (expense) income primarily consists of interest expense on deferred accounts payable, changes in the fair value of financial instruments, and interest income[124](index=124&type=chunk) [Results of Operations - Six Months Ended June 30, 2025 and 2024](index=40&type=section&id=Results%20of%20Operations%20-%20Six%20Months%20Ended%20June%2030,%202025%20and%202024) This section provides a comparative analysis of operating results for the six-month periods **Results of Operations (Six Months Ended June 30)** | Metric | 2025 | 2024 | Change | | :--- | :--- | :--- | :--- | | Research and development | $14,214,034 | $3,749,599 | $10,464,435 | | General and administrative | $3,430,723 | $2,640,758 | $789,965 | | Total operating expenses | $17,644,757 | $6,390,357 | $11,254,400 | | Net loss | $(17,464,932) | $(6,258,745) | $(11,206,187) | - Research and development expenses increased by **$10.5 million (284%)** for the six months ended June 30, 2025, primarily due to the PMN310 phase 1b trial[128](index=128&type=chunk) - General and administrative expenses increased by **$0.8 million (31%)**, driven by higher employee salaries and benefits (including severance costs) and facility-related costs, partially offset by decreased professional and consulting fees[129](index=129&type=chunk) [Results of Operations - Three Months Ended June 30, 2025 and 2024](index=44&type=section&id=Results%20of%20Operations%20-%20Three%20Months%20Ended%20June%2030,%202025%20and%202024) This section provides a comparative analysis of operating results for the three-month periods **Results of Operations (Three Months Ended June 30)** | Metric | 2025 | 2024 | Change | | :--- | :--- | :--- | :--- | | Research and development | $8,749,784 | $1,625,821 | $7,123,963 | | General and administrative | $1,434,877 | $1,087,885 | $346,992 | | Total operating expenses | $10,184,661 | $2,713,706 | $7,470,955 | | Net loss | $(10,117,029) | $(2,623,657) | $(7,493,372) | - Research and development expenses increased by **$7.1 million (438%)** for the three months ended June 30, 2025, primarily due to the PMN310 phase 1b trial[132](index=132&type=chunk) - General and administrative expenses increased by **$0.3 million (32%)**, driven by higher employee salaries, benefits, and share-based compensation, partially offset by decreased patent and professional/consulting fees[133](index=133&type=chunk)[134](index=134&type=chunk) [Liquidity and Capital Resources](index=46&type=section&id=Liquidity%20and%20Capital%20Resources) This section discusses the company's financial liquidity, capital resources, and funding needs [Sources of Liquidity](index=46&type=section&id=Sources%20of%20Liquidity) This subsection details the company's primary sources of funding and its current financial position - The company is a pre-revenue development stage company, financing operations through the sale of equity and debt securities and the conversion of warrants and share options[136](index=136&type=chunk) - As of June 30, 2025, cash was **$4.5 million**, with a net loss of **$17.5 million** and negative cash flow from operations of **$8.8 million** for the six months ended June 30, 2025[146](index=146&type=chunk) - In July 2025, the company received aggregate gross proceeds of **$21.6 million** from a registered direct offering, private placements, and discounted warrant exercises[145](index=145&type=chunk)[146](index=146&type=chunk) - Management believes these conditions raise **substantial doubt** about the company's ability to continue as a going concern within the next 12 months, requiring additional funding for future clinical activities and existing liabilities[146](index=146&type=chunk) [Cash Flows](index=48&type=section&id=Cash%20Flows) This subsection provides a detailed analysis of the company's cash flow activities [Cash Flows Used in Operating Activities](index=48&type=section&id=Cash%20Flows%20Used%20in%20Operating%20Activities) This section analyzes the cash used for the company's principal operations - Cash used in operating activities was **$8.8 million** for the six months ended June 30, 2025, primarily due to a net loss of **$17.5 million**, partially offset by non-cash adjustments and favorable changes in operating assets and liabilities[148](index=148&type=chunk) - For the six months ended June 30, 2024, cash used in operating activities was **$11.8 million**, driven by a net loss of **$6.3 million** and a net change of **$5.5 million** in operating assets and liabilities, including a **$5.9 million** repayment on deferred accounts payable[149](index=149&type=chunk)[150](index=150&type=chunk) [Cash Flows Used in Investing Activities](index=50&type=section&id=Cash%20Flows%20Used%20in%20Investing%20Activities) This section analyzes cash flows related to the acquisition and disposal of long-term assets - There was no cash used in investing activities during the six months ended June 30, 2025, or 2024[151](index=151&type=chunk) [Cash Flows from Financing Activities](index=50&type=section&id=Cash%20Flows%20from%20Financing%20Activities) This section analyzes cash flows related to equity and debt financing - No cash was provided by financing activities during the six months ended June 30, 2025[152](index=152&type=chunk) - Cash provided by financing activities during the six months ended June 30, 2024, was **$0.2 million** from the sale of Common Shares under the At The Market Offering Agreement[152](index=152&type=chunk) [Critical Accounting Policies and Estimates](index=50&type=section&id=Critical%20Accounting%20Policies%20and%20Estimates) This section highlights the accounting policies and estimates that are most critical to the financial statements - The company's financial statements are prepared in accordance with U.S. GAAP, requiring management to make significant judgments and estimates, particularly for accruals of research and development expenses[153](index=153&type=chunk) - No material changes to critical accounting estimates have occurred since December 31, 2024[154](index=154&type=chunk) [Recently Issued Accounting Pronouncements](index=50&type=section&id=Recently%20Issued%20Accounting%20Pronouncements) This section discusses the potential impact of new accounting standards - The company is analyzing the impact of ASU 2024-03, which requires disaggregation of income statement expenses, effective for annual periods starting January 1, 2027[43](index=43&type=chunk)[155](index=155&type=chunk) [Emerging Growth Company Status](index=50&type=section&id=Emerging%20Growth%20Company%20Status) This section describes the company's status as an emerging growth company and its implications - The company is an "emerging growth company" under the JOBS Act and has elected to use the extended transition period for adopting new or revised accounting standards[156](index=156&type=chunk)[157](index=157&type=chunk) [Fully Diluted Share Capital](index=50&type=section&id=Fully%20Diluted%20Share%20Capital) This section provides a summary of the company's fully diluted share capital **Fully Diluted Share Capital (June 30, 2025)** | Item | Number of Common Shares and Common Share Equivalents | | :--- | :--- | | Common Shares | 32,689,190 | | Options issued and outstanding | 3,760,859 | | Warrants | 57,141,386 | | Deferred share units | 1,061 | | **Total** | **93,592,496** | [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=52&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) This section discusses the company's exposure to various market risks, including credit, liquidity, and inflation risk - The company is exposed to credit risk, liquidity risk, and inflation risk in its normal course of business[159](index=159&type=chunk) - Credit risk is managed by placing cash with accredited financial institutions and investing in high-quality government and corporate issuers with low credit risk[160](index=160&type=chunk) - Liquidity risk is managed by continuously monitoring actual and projected cash flows and relying on external fundraising, as the company is a pre-revenue development stage entity[161](index=161&type=chunk) - Inflation did not have a material effect on the company's business, financial condition, or results of operations during the six months ended June 30, 2025[162](index=162&type=chunk) [Item 4. Controls and Procedures](index=52&type=section&id=Item%204.%20Controls%20and%20Procedures) This section evaluates the effectiveness of the company's disclosure controls and procedures and discusses internal control over financial reporting [Evaluation of Disclosure Controls and Procedures](index=52&type=section&id=Evaluation%20of%20Disclosure%20Controls%20and%20Procedures) This subsection presents management's conclusion on the effectiveness of disclosure controls - The company's management concluded that its disclosure controls and procedures were **not effective** as of June 30, 2025, due to a previously identified material weakness in internal control over financial reporting[164](index=164&type=chunk) [Material Weakness in Internal Control Over Financial Reporting](index=52&type=section&id=Material%20Weakness%20in%20Internal%20Control%20Over%20Financial%20Reporting) This subsection describes the identified material weakness in internal controls - A **material weakness** was identified in the company's internal control over financial reporting due to the failure to design sufficient and appropriate review controls over certain fair value calculations, including the July 2024 PIPE Warrant Liability[165](index=165&type=chunk) - This material weakness could potentially result in a material misstatement of the company's annual or interim financial statements not being prevented or detected on a timely basis[165](index=165&type=chunk) [Remediation Measures](index=54&type=section&id=Remediation%20Measures) This subsection outlines the steps being taken to address the material weakness - The company has implemented measures to remediate the material weakness, including ensuring appropriate levels of review over the calculation of the fair value of its financial instruments, but there is no assurance these initiatives will ultimately have the intended effects[169](index=169&type=chunk) [Changes in Internal Control Over Financial Reporting](index=54&type=section&id=Changes%20in%20Internal%20Control%20Over%20Financial%20Reporting) This subsection reports any changes to internal controls during the reporting period - Except for the remediation measures related to the material weakness, there have been no other changes in internal control over financial reporting during the three months ended June 30, 2025, that materially affected or are reasonably likely to materially affect it[170](index=170&type=chunk) [PART II — OTHER INFORMATION](index=54&type=section&id=PART%20II%20OTHER%20INFORMATION) This part contains other required disclosures, including legal proceedings, risk factors, and exhibits [Item 1. Legal Proceedings](index=54&type=section&id=Item%201.%20Legal%20Proceedings) This section discloses any material pending legal proceedings - The company is not currently a party to any material litigation or legal proceedings that, in management's opinion, are likely to have a material adverse effect on its business[172](index=172&type=chunk) [Item 1A. Risk Factors](index=54&type=section&id=Item%201A.%20Risk%20Factors) This section highlights key risks that could adversely affect the company's business, financial condition, and results of operations - There is **substantial doubt** about the company's ability to continue as a **going concern** due to incurred losses and the need for significant additional financing to fund development programs and operations[174](index=174&type=chunk)[175](index=175&type=chunk) - The company has identified a **material weakness** in its internal control over financial reporting related to insufficient review controls over fair value measurements, which could adversely affect financial reporting and investor confidence[178](index=178&type=chunk)[179](index=179&type=chunk) - Changes to U.S. fiscal, tax, and other federal policies, including tariffs and tax reforms, could materially and adversely affect the company's business[182](index=182&type=chunk)[183](index=183&type=chunk)[184](index=184&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=58&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) This section reports on sales of unregistered equity securities - No unregistered sales of equity securities or use of proceeds occurred during the reporting period[187](index=187&type=chunk) [Item 3. Defaults Upon Senior Securities](index=58&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) This section reports any defaults on senior securities - No defaults upon senior securities occurred during the reporting period[188](index=188&type=chunk) [Item 4. Mine Safety Disclosures](index=58&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This section addresses mine safety disclosures, if applicable - This item is not applicable to the company[189](index=189&type=chunk) [Item 5. Other Information](index=58&type=section&id=Item%205.%20Other%20Information) This section includes any other information not previously reported - No officer or director adopted or terminated a Rule 10b5-1 or non-Rule 10b5-1 trading arrangement during the three months ended June 30, 2025[189](index=189&type=chunk) [Item 6. Exhibits](index=59&type=section&id=Item%206.%20Exhibits) This section lists the documents filed as exhibits to the report - The exhibits include forms of Pre-Funded Warrants and Warrants, the 2025 Stock Option and Incentive Plan, Registration Rights Agreements, and certifications required by the Sarbanes-Oxley Act[191](index=191&type=chunk) [Signatures](index=60&type=section&id=Signatures) This section contains the legally required signatures of the company's certifying officers - The report was signed by Neil Warma, Chief Executive Officer, and Daniel Geffken, Chief Financial Officer, on August 13, 2025[197](index=197&type=chunk)

Katapult Delivers Second Quarter Gross Originations, Revenue and Adjusted EBITDA Above Outlook Raising Full Year 2025 Gross Originations Outlook Gross Originations, Revenue and Adjusted EBITDA Growth to Continue In Third Quarter PLANO, Texas, August 13, 2025 — Katapult Holdings, Inc. ("Katapult" or the "Company") (NASDAQ: KPLT), an e-commerce-focused financial technology company, today reported its financial results for the second quarter ended June 30, 2025. "We came out of the gate strong in 2025 and that ...

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 June 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 001-40215 Instil Bio, Inc. (Exact name of registrant as specified in its charter) Delaware 83-2072195 (State or other jurisdic ...

Exhibit 99.1 PDS Biotech Reports Second Quarter 2025 Financial Results and Provides Clinical Programs Update Multiple Abstracts Presented at the 2025 American Society of Clinical Oncology Annual Meeting Conference call and webcast today at 8:00 a.m. Eastern Time PRINCETON, N.J., August 13, 2025 -- PDS Biotechnology Corporation (Nasdaq: PDSB) ("PDS Biotech" or the "Company"), a late- stage immunotherapy company focused on transforming how the immune system targets and kills cancers, today provided a business ...

Exhibit 99.1 Aura Biosciences Reports Second Quarter 2025 Financial Results and Business Highlights Continued Clinical Program Execution in the Phase 3 CoMpass Trial in Early Choroidal Melanoma and the Phase 1b/2 Trial in Non-Muscle Invasive Bladder Cancer (NMIBC) Strengthened Balance Sheet with $75 Million Equity Financing; Cash Position Expected to Fund Operations into the First Half of 2027 Metastases to the Choroid Metastases to the choroid is an indication with high unmet medical need and no approved t ...

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 June 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 PERSPECTIVE THERAPEUTICS, INC. (Exact name of registrant as specified in its charter) | Del ...

[FORM 10-Q Filing Information](index=1&type=section&id=FORM%2010-Q) [Registrant Information](index=1&type=section&id=Registrant%20Information) This report is a quarterly filing by Perspective Therapeutics, Inc. for the period ended June 30, 2025, registered in Delaware, listed on NYSE American LLC as CATX, and classified as a non-accelerated filer and smaller reporting company - Company Name: PERSPECTIVE THERAPEUTICS, INC[1](index=1&type=chunk) - Reporting Period: Quarter ended June 30, 2025[1](index=1&type=chunk) Company Registration Information | Metric | Details | | :--- | :--- | | Registered State | Delaware | | Stock Symbol | CATX | | Registered Exchange | NYSE American LLC | | Filing Status | Non-accelerated filer, Smaller reporting company | | Common Stock Par Value | $0.001 | | Common Stock Outstanding (as of August 11, 2025) | 74,262,990 | [CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS](index=3&type=section&id=CAUTIONARY%20NOTE%20REGARDING%20FORWARD-LOOKING%20STATEMENTS) [Forward-Looking Statements](index=3&type=section&id=Forward-Looking%20Statements) This report contains forward-looking statements under the Private Securities Litigation Reform Act of 1995, covering future financial conditions, operations, strategies, and industry trends - Forward-looking statements in this report are intended to qualify for the safe harbor provisions of the Private Securities Litigation Reform Act of 1995[5](index=5&type=chunk) - Forward-looking statements cover the company's future financial condition, operating results, business strategy, management objectives, industry trends, and future events[6](index=6&type=chunk) - Actual results may differ materially from expectations due to risks and uncertainties described in the "Risk Factors" section[7](index=7&type=chunk) [AVAILABLE INFORMATION](index=4&type=section&id=AVAILABLE%20INFORMATION) [Company Website and SEC Filings](index=4&type=section&id=Company%20Website%20and%20SEC%20Filings) The company provides free access to its annual, quarterly, and current reports, and other SEC filings on its website after electronic submission - The company's annual, quarterly, current reports, and other SEC filings and amendments are available for free on its website, www.perspectivetherapeutics.com, after filing with the SEC[9](index=9&type=chunk) [PART I FINANCIAL INFORMATION](index=5&type=section&id=PART%20I%20FINANCIAL%20INFORMATION) [Item 1 Financial Statements](index=5&type=section&id=Item%201%20Financial%20Statements) This section presents the company's unaudited condensed consolidated financial statements for the period ended June 30, 2025, including balance sheets, statements of operations and comprehensive loss, cash flows, and changes in stockholders' equity [Condensed Consolidated Balance Sheets](index=6&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) Presents the company's financial position, including assets, liabilities, and equity, as of June 30, 2025, and December 31, 2024 Condensed Consolidated Balance Sheets Key Data (in thousands of US dollars) | Metric | June 30, 2025 (Unaudited) | December 31, 2024 | | :--- | :--- | :--- | | 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 | | Intangible assets, IPR&D | $50,000 | $50,000 | | Total assets | $310,725 | $341,101 | | Total current liabilities | $12,986 | $18,230 | | Total liabilities | $45,033 | $50,433 | | Total stockholders' equity | $265,692 | $290,668 | | Accumulated deficit | $(271,381) | $(231,719) | - As of June 30, 2025, the company's cash and cash equivalents decreased by **53.15%** year-over-year, total assets decreased by **8.89%**, total liabilities decreased by **10.71%**, total stockholders' equity decreased by **8.59%**, and accumulated deficit increased by **17.16%**[13](index=13&type=chunk) [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) Details the company's revenues, expenses, and net loss for the three and six months ended June 30, 2025, and 2024 Condensed Consolidated Statements of Operations and Comprehensive Loss Key Data (in thousands of US dollars, 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 expenses | $16,620 | $9,275 | $30,952 | $16,727 | | General and administrative expenses | $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) | - For the three months ended June 30, 2025, grant revenue decreased by **44.9%** year-over-year, research and development expenses increased by **79.2%**, operating loss expanded by **68.5%**, net loss expanded by **83.6%**, and loss per share expanded by **61.1%**[14](index=14&type=chunk) - For the six months ended June 30, 2025, grant revenue decreased by **25.7%** year-over-year, research and development expenses increased by **85.0%**, operating loss expanded by **68.2%**, net loss expanded by **65.3%**, and loss per share expanded by **31.7%**[14](index=14&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=8&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Summarizes the cash inflows and outflows from operating, investing, and financing activities for the six months ended June 30, 2025, and 2024 Condensed Consolidated Statements of Cash Flows Key Data (in thousands of US dollars) | Metric | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--- | :--- | :--- | | Net cash (used in) provided by operating activities | $(41,535) | $4,946 | | Net cash (used in) provided by investing activities | $(1,301) | $(50,592) | | Net cash provided by financing activities | $10,105 | $288,412 | | Net (decrease) increase in cash and cash equivalents | $(32,731) | $242,766 | | Cash and cash equivalents at end of period | $28,849 | $252,186 | - For the six months ended June 30, 2025, cash flow from operating activities shifted from a net inflow to a net outflow, cash outflow from investing activities significantly decreased, and cash inflow from financing activities substantially declined, leading to a significant reduction in cash and cash equivalents at period-end[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) Details the changes in the company's common stock, additional paid-in capital, accumulated other comprehensive income (loss), and accumulated deficit for the periods presented Condensed Consolidated Statements of Changes in Stockholders' Equity Key Data (in thousands of US dollars, except shares) | Metric | Balance as of December 31, 2024 | Balance as of March 31, 2025 | Balance as of June 30, 2025 | | :--- | :--- | :--- | :--- | | Common stock shares | 70,671,464 | 74,050,841 | 74,262,990 | | Common stock amount | $70 | $73 | $74 | | Additional paid-in capital | $522,368 | $534,449 | $536,996 | | Accumulated other comprehensive income (loss) | $(51) | $19 | $3 | | Accumulated deficit | $(231,719) | $(249,896) | $(271,381) | | Total stockholders' equity | $290,668 | $284,645 | $265,692 | - As of June 30, 2025, total stockholders' equity decreased by approximately **8.6%** compared to December 31, 2024, primarily due to an increase in net loss, despite an increase in additional paid-in capital from common stock issuance through the ATM agreement[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) Provides detailed explanations and additional information supporting the unaudited 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) Outlines the basis of financial statement presentation and summarizes the company's significant accounting policies, including its business nature and recent corporate actions - The company is a radiopharmaceutical development company focused on advanced therapeutic applications for systemic cancer[22](index=22&type=chunk) - On April 12, 2024, the company completed the sale of its Cesium-131 brachytherapy business, with related financial information presented as discontinued operations[24](index=24&type=chunk) - On June 14, 2024, the company effected a 1-for-10 reverse stock split, and all historical per share data has been retroactively adjusted[25](index=25&type=chunk) - The company currently operates in a single operating and reporting segment: radiopharmaceutical development[26](index=26&type=chunk) Liquidity Position (in thousands of US dollars) | Metric | June 30, 2025 | | :--- | :--- | | Cash, cash equivalents, and short-term investments | $191,600 | | Accumulated deficit | $(271,400) | - The company expects its cash resources as of June 30, 2025, to be sufficient to support its currently planned clinical milestones and operating investments through the end of 2026[28](index=28&type=chunk) [2. Loss per Share](index=12&type=section&id=2.%20Loss%20per%20Share) Explains the calculation of loss per share, including the treatment of potentially dilutive securities - Due to the company's net loss position, common stock warrants and options are considered anti-dilutive in the calculation of diluted loss per share[32](index=32&type=chunk) Potentially Dilutive Securities (in shares) | Security Type | June 30, 2025 | June 30, 2024 | | :--- | :--- | :--- | | Common stock warrants | 415,779 | 416,164 | | Common stock options | 10,185,506 | 6,934,022 | | Total potentially dilutive securities | 10,601,285 | 7,350,186 | [3. Investments and Agreements](index=14&type=section&id=3.%20Investments%20and%20Agreements) Details various investment and financing agreements, including ATM agreements, public offerings, and strategic partnerships - 2024 ATM Agreement: On February 18, 2025, the company sold **3,379,377** shares of common stock through this agreement, generating gross proceeds of approximately **$10.2 million**[36](index=36&type=chunk)[40](index=40&type=chunk) - May 2024 Registered Offering: Completed on May 29, 2024, generating gross proceeds of approximately **$80 million**, involving the issuance of common stock and pre-funded warrants, with all pre-funded warrants exercised in the second quarter of 2025[41](index=41&type=chunk)[42](index=42&type=chunk)[43](index=43&type=chunk) - March 2024 Institutional Investor Private Placement: Completed on March 6, 2024, generating gross proceeds of approximately **$87.4 million**, involving the issuance of **9,200,998** shares of common stock[44](index=44&type=chunk)[45](index=45&type=chunk) - Lantheus Agreements: Include an investment agreement with Lantheus on January 8, 2024 (sale of **5,634,235** shares of common stock), an asset purchase agreement (acquisition of Progenics' radiopharmaceutical manufacturing facility for **$8 million** cash), and an option agreement (Lantheus paid **$28 million** for exclusive negotiation rights for [212Pb]VMT-α-NET license)[47](index=47&type=chunk)[48](index=48&type=chunk)[52](index=52&type=chunk)[53](index=53&type=chunk) - January 2024 Public Offering: Completed on January 22, 2024, generating gross proceeds of approximately **$69 million**, involving the issuance of common stock and pre-funded warrants, with all pre-funded warrants exercised in the fourth quarter of 2024[57](index=57&type=chunk)[58](index=58&type=chunk)[59](index=59&type=chunk) - 2023 ATM Agreement: On April 11, 2024, **3,535,246** shares of common stock were sold, generating gross proceeds of approximately **$49.5 million**, and this agreement was terminated on August 12, 2024[60](index=60&type=chunk)[62](index=62&type=chunk)[63](index=63&type=chunk) [4. Discontinued Operations](index=17&type=section&id=4.%20Discontinued%20Operations) Reports on the financial impact and details of the company's divested Cesium-131 brachytherapy business - The company completed the sale of its Cesium-131 brachytherapy business on April 12, 2024, receiving common stock of GT Medical and cash royalties on future sales[64](index=64&type=chunk)[65](index=65&type=chunk) Discontinued Operations Income (Loss) (in thousands of US dollars) | 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 | | :--- | :--- | :--- | :--- | :--- | | Net sales | $0 | $205 | $0 | $2,178 | | Total gain (loss) from discontinued operations | $514 | $(490) | $514 | $(949) | - In the second quarter of 2025, the company recognized **$0.2 million** in royalty revenue and reduced its environmental waste remediation reserve by **$0.3 million** based on estimates from a hazardous waste disposal vendor[67](index=67&type=chunk) [5. Property and Equipment](index=18&type=section&id=5.%20Property%20and%20Equipment) Provides details on the company's property and equipment, including recent acquisitions and commitments for manufacturing facilities - In 2024, the company purchased buildings in Houston, Chicago, and Los Angeles, planned for the production of its product candidates[70](index=70&type=chunk) - The company entered into equipment and services agreements with Comecer SpA totaling approximately **€49 million** for the procurement of radiopharmaceutical manufacturing equipment[70](index=70&type=chunk) Property and Equipment, Net (in thousands of US dollars) | Metric | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Property and equipment, net | $62,599 | $57,321 | | Construction in progress | $47,991 | $42,601 | [6. Other Intangible Assets](index=19&type=section&id=6.%20Other%20Intangible%20Assets) Discusses the company's intangible assets, specifically in-process research and development (IPR&D) - The company's in-process research and development (IPR&D) asset remained unchanged at **$50 million** as of June 30, 2025, and December 31, 2024[72](index=72&type=chunk) - No impairment testing of intangible assets was conducted in the second quarter of 2025[72](index=72&type=chunk) [7. Available-for-Sale Securities](index=19&type=section&id=7.%20Available-for-Sale%20Securities) Details the company's available-for-sale securities, their fair value, and management's assessment of unrealized losses Fair Value of Available-for-Sale Securities (in thousands of US dollars) | Metric | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Total available-for-sale securities | $162,729 | $165,336 | - The company classifies available-for-sale securities as current assets to meet working capital needs[75](index=75&type=chunk) - As of June 30, 2025, **71** available-for-sale securities were in an unrealized loss position, but the company does not believe a sale of these securities will be required[75](index=75&type=chunk) [8. Fair Value Measurements](index=20&type=section&id=8.%20Fair%20Value%20Measurements) Explains the fair value measurement of the company's financial instruments, primarily cash equivalents and available-for-sale securities Fair Value of Cash Equivalents and Available-for-Sale Securities (in thousands of US dollars) | Metric | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Total cash equivalents | $25,095 | $59,720 | | Total available-for-sale securities | $162,729 | $165,336 | | Total cash equivalents and available-for-sale securities | $187,824 | $225,056 | - The company's cash equivalents and available-for-sale securities are primarily measured at fair value using quoted prices in active markets (Level 1) or observable market data (Level 2), with no Level 3 financial instruments[76](index=76&type=chunk)[77](index=77&type=chunk) [9. Share-Based Compensation](index=21&type=section&id=9.%20Share-Based%20Compensation) Provides information on the company's share-based compensation plans and related expenses - On May 31, 2024, shareholders approved the amended 2020 Equity Incentive Plan, increasing the total authorized common stock by **4,870,092** shares to **12,500,000** shares and adjusting the "evergreen" provision[79](index=79&type=chunk) Share-Based Compensation Expense (in thousands of US dollars) | 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 | | :--- | :--- | :--- | :--- | :--- | | Research and development expenses | $958 | $259 | $1,855 | $522 | | General and administrative expenses | $1,445 | $328 | $2,646 | $687 | | Total share-based compensation expense | $2,403 | $587 | $4,501 | $1,209 | - For the six months ended June 30, 2025, total share-based compensation expense increased by **272.3%** year-over-year[80](index=80&type=chunk) [10. Commitments and Contingencies](index=22&type=section&id=10.%20Commitments%20and%20Contingencies) Details the company's commitments and contingent liabilities, including legal settlements and purchase obligations - The company expects to resolve a shareholder lawsuit for a total amount not exceeding **$0.2 million** and has accrued a corresponding liability[81](index=81&type=chunk) - In May 2025, the company entered into a purchase order with the U.S. Department of Energy (DOE), committing to purchase approximately **$8.4 million** of Thorium-228 between 2025 and 2026[82](index=82&type=chunk) [11. Related Parties](index=22&type=section&id=11.%20Related%20Parties) Discloses transactions and relationships with related parties, specifically Lantheus - Lantheus is a significant shareholder, holding **19.99%** of common stock as of January 8, 2024, and increasing to approximately **19.9%** after the March 2024 private placement[83](index=83&type=chunk)[86](index=86&type=chunk) - On January 8, 2024, the company entered into an asset purchase agreement with Progenics, an affiliate of Lantheus, to acquire its manufacturing facility for **$8 million**[84](index=84&type=chunk) - Lantheus paid **$28 million** for exclusive negotiation rights for [212Pb]VMT-α-NET, of which **$1.4 million** was recognized as "other income from related parties" after the right of first refusal and last look expired on January 8, 2025[85](index=85&type=chunk)[86](index=86&type=chunk) [12. Leases](index=24&type=section&id=12.%20Leases) Provides information on the company's operating leases, including lease expenses, remaining terms, and future payment obligations - The company entered into several new operating lease agreements in 2024 and 2023, including laboratory and office spaces in Iowa, New Jersey, and Washington[88](index=88&type=chunk)[89](index=89&type=chunk)[90](index=90&type=chunk)[92](index=92&type=chunk) Operating Lease Expense (in thousands of US dollars) | 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 | | :--- | :--- | :--- | :--- | :--- | | Operating lease expense | $300 | $200 | $600 | $300 | - As of June 30, 2025, the company's operating leases had a weighted-average remaining term of **2.8 years** and a discount rate of **8%**[93](index=93&type=chunk) Future Operating Lease Payments and Lease Liabilities (in thousands of US dollars) | Year | Amount | | :--- | :--- | | 2025 (remaining six months) | $559 | | 2026 | $647 | | 2027 | $493 | | 2028 | $443 | | Total | $2,142 | | Less: Estimated interest | $(224) | | Total lease liabilities | $1,918 | | Less: Current portion | $(847) | | Non-current lease liabilities | $1,071 | - Asset retirement obligations related to the Richland facility were transferred to GT Medical, but the company retains an estimated **$0.2 million** liability for hazardous waste removal[95](index=95&type=chunk) [13. Note Payable](index=25&type=section&id=13.%20Note%20Payable) Details the company's note payable, including its purpose, interest rate, and maturity - On December 29, 2022, the company obtained a **$1.7 million** promissory note for the purchase of land and buildings in Coralville, Iowa, with an annual interest rate of **6.15%**[96](index=96&type=chunk) Note Payable (in thousands of US dollars) | Metric | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Total note payable | $1,651 | $1,677 | | Less: Current portion | $(54) | $(52) | | Note payable, long-term portion | $1,597 | $1,625 | - The remaining balance of approximately **$1.5 million** on this note 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%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the company's financial condition and operating results for the period ended June 30, 2025, covering business overview, clinical programs, funding, manufacturing, and capital activities [Overview](index=26&type=section&id=Overview) Provides a high-level summary of the company's business as a radiopharmaceutical developer and its focus on targeted cancer therapies - The company is a radiopharmaceutical development company utilizing proprietary Lead-212 (212Pb) alpha-emitting isotope technology to develop targeted therapies and complementary imaging diagnostics (theranostics) for cancer[99](index=99&type=chunk) - The company's VMT-α-NET (neuroendocrine tumors), VMT01 (melanoma), and PSV359 (solid tumors) programs are all in Phase 1/2a imaging and therapeutic clinical trials[100](index=100&type=chunk) [Program Candidates](index=26&type=section&id=Program%20Candidates) Details the progress and key findings of the company's various radiopharmaceutical program candidates in clinical development [VMT-α-NET](index=26&type=section&id=VMT-%CE%B1-NET) Focuses on the development and clinical trial progress of VMT-α-NET for treating SSTR2-expressing neuroendocrine tumors - VMT-α-NET is designed to target tumor cells expressing somatostatin receptor type 2 (SSTR2) for the treatment of unresectable or metastatic SSTR2-expressing neuroendocrine tumors (NETs)[101](index=101&type=chunk) - Phase 1/2a study progress: Cohort 2 completed enrollment of **46** patients, Cohort 3 opened in late June 2025, with **2** patients treated as of July 31, 2025[102](index=102&type=chunk) - Safety data presented at the 2025 ASCO meeting showed no dose-limiting toxicities (DLTs), discontinuations due to adverse events (AEs), or Grade 4/5 treatment-related AEs observed in **42** patients[104](index=104&type=chunk) - Preliminary efficacy data showed **3** confirmed responses and **1** unconfirmed response, with **7** patients achieving disease control in the first **9** patients[105](index=105&type=chunk) [VMT01](index=28&type=section&id=VMT01) Provides an update on the VMT01 program, targeting MC1R-expressing melanoma, including its fast track designation and combination therapy studies - VMT01 targets melanoma expressing melanocortin 1 receptor (MC1R) for the treatment of second-line or later MC1R-positive metastatic melanoma[111](index=111&type=chunk) - In September 2024, the FDA granted Fast Track designation to [212Pb]VMT01[112](index=112&type=chunk) - The company is collaborating with Bristol Myers Squibb to evaluate the safety and tolerability of [212Pb]VMT01 in combination with nivolumab[113](index=113&type=chunk) - Preliminary results showed no DLTs in Cohort 1 and Cohort 2, with AEs mostly Grade 1/2 and no reports of nephrotoxicity[114](index=114&type=chunk)[115](index=115&type=chunk) - The Safety Monitoring Committee (SMC) recommended exploring a lower dose level of **1.5 mCi**, with enrollment open for both monotherapy and combination with nivolumab[117](index=117&type=chunk) [PSV359](index=30&type=section&id=PSV359) Details the development of PSV359, a novel cyclic peptide targeting FAP-α for pan-cancer potential, and its clinical trial initiation - PSV359 is a novel cyclic peptide targeting FAP-α (fibroblast activation protein alpha) expressed on tumor stromal cells and some cancer cells, with pan-cancer target potential[118](index=118&type=chunk) - First-in-human SPECT/CT imaging showed [203Pb]PSV359 had good tumor targeting and retention, with rapid clearance from normal organs[118](index=118&type=chunk)[119](index=119&type=chunk) - An IND application was submitted in December 2024, approved by the FDA in the first quarter of 2025, and the first patient received [212Pb]PSV359 treatment on April 29, 2025[121](index=121&type=chunk) [Discovery Program](index=30&type=section&id=Discovery%20Program) Describes the company's discovery efforts to develop new constructs for potential first-in-human imaging and therapeutic benefits - The company's discovery team is preparing several new constructs for potential first-in-human imaging as a de-risking step for potential therapeutic benefit, including a pre-targeting platform licensed from Stony Brook University[122](index=122&type=chunk) [Intellectual Property](index=30&type=section&id=Intellectual%20Property) Highlights recent patent grants covering the company's 212Pb production technology, VMT-α-NET compound, and lead-specific chelator - The company recently obtained two U.S. patents and one European patent covering its 212Pb scalable production technology, VMT-α-NET compound, and lead-specific chelator[123](index=123&type=chunk) - The 212Pb generation technology patent is valid until **August 2044**, the VMT-α-NET compound patent until **January 2041**, and the lead-specific chelator European patent until **April 2039**[123](index=123&type=chunk) [Funding Requirements](index=30&type=section&id=Funding%20Requirements) Discusses the company's anticipated funding needs to advance its clinical programs and expand operations, and its current liquidity position - The company expects expenses to continue increasing as preclinical activities, clinical trials, and commercialization of product candidates progress[124](index=124&type=chunk) - As of June 30, 2025, the company had **$191.6 million** in cash, cash equivalents, and short-term investments, expected to be sufficient to support its currently planned clinical milestones and operating investments through the end of 2026[126](index=126&type=chunk) - Management anticipates a significant increase in research and development and general and administrative expenses to advance clinical and preclinical assets[126](index=126&type=chunk) [Manufacturing and Supply](index=32&type=section&id=Manufacturing%20and%20Supply) Outlines the company's strategy for manufacturing and supplying its radiopharmaceutical candidates, including partnerships and facility plans - The company assembles and manufactures its radiopharmaceutical product candidates by chelating 212Pb with targeting peptides[127](index=127&type=chunk) - The company plans to utilize a combination of third-party contract manufacturing organizations (CMOs) and its own FDA CGMP-compliant manufacturing sites to produce and distribute doses[127](index=127&type=chunk) - The company entered into a purchase order with the U.S. Department of Energy (DOE), committing to purchase approximately **$8.4 million** of Thorium-228 between 2025 and 2026[128](index=128&type=chunk) - In 2024, the company entered into equipment and services agreements with Comecer SpA totaling approximately **€49 million** for the procurement of radiopharmaceutical manufacturing equipment[129](index=129&type=chunk) [Facility Acquisitions](index=32&type=section&id=Facility%20Acquisitions) Details the company's recent acquisitions of buildings and a manufacturing facility to support its production capabilities - In 2024, the company acquired buildings in Houston, Chicago, and Los Angeles, planned for the manufacturing of its product candidates[130](index=130&type=chunk) - The company also acquired assets and related leases for Lantheus' radiopharmaceutical manufacturing facility in Somerset, New Jersey, achieving its first shipment and patient dosing in October 2024[131](index=131&type=chunk) [Capital Market Activities](index=33&type=section&id=Capital%20Market%20Activities) Reports on the company's recent capital market activities, including its ATM agreement for common stock sales - On August 13, 2024, the company entered into the 2024 ATM Agreement, allowing for the sale of up to **$250 million** of common stock; as of February 18, 2025, **3,379,377** shares of common stock were sold, generating gross proceeds of approximately **$10.2 million**[134](index=134&type=chunk)[138](index=138&type=chunk) [Brachytherapy Divestiture](index=33&type=section&id=Brachytherapy%20Divestiture) Provides an update on the completed divestiture of the Cesium-131 brachytherapy business and related financial impacts - The company completed the sale of its Cesium-131 brachytherapy business to GT Medical Technologies, Inc. on April 12, 2024[139](index=139&type=chunk) - As part of the transaction, the company received common stock of GT Medical and cash royalties on future sales for four years, with royalty rates dependent on sales and product type[140](index=140&type=chunk)[143](index=143&type=chunk) - In the second quarter of 2025, the company recognized **$0.2 million** in royalty revenue and reduced its environmental waste remediation reserve by **$0.3 million**[140](index=140&type=chunk) [Legislative Update](index=33&type=section&id=Legislative%20Update) Informs about recent tax legislation and its anticipated impact on the company's financial performance - On July 4, 2025, the President signed the "One Big Beautiful Bill Act" (OBBBA) tax legislation, which the company does not expect to have a material impact on its 2025 financial results[142](index=142&type=chunk) [Critical Accounting Policies and Estimates](index=35&type=section&id=Critical%20Accounting%20Policies%20and%20Estimates) States that there have been no significant changes to the company's critical accounting policies and estimates - There have been no significant changes to the company's 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) Analyzes the company's operating performance, focusing on changes in grant revenue and operating expenses [Grant Revenue](index=35&type=section&id=Grant%20Revenue) Discusses the trends and sources of the company's grant revenue Grant Revenue (in thousands of US dollars) | 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 | - Grant revenue decreased year-over-year, primarily from work with the National Institutes of Health, as the company currently generates no sales revenue from its alpha-therapeutic product candidates[148](index=148&type=chunk) [Operating Expenses](index=35&type=section&id=Operating%20Expenses) Examines the changes and drivers behind the company's operating expenses, including research and development and general and administrative costs [Research and Development](index=35&type=section&id=Research%20and%20Development) Analyzes the increase in research and development expenses, attributing it to clinical activities, drug costs, and personnel Research and Development Expenses (in thousands of US dollars) | 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 | | :--- | :--- | :--- | :--- | :--- | | Research and development expenses | $16,620 | $9,275 | $30,952 | $16,727 | - Research and development expenses increased by **$7.3 million** and **$14.2 million** for the three and six-month periods, respectively, primarily due to increased clinical site activities, drug and delivery costs, and higher personnel costs, including share-based compensation[149](index=149&type=chunk) - Management expects research and development expenses to continue increasing to invest in new radiopharmaceutical development and expand manufacturing capabilities, while also evaluating the potential impact of trade policies on raw material costs[150](index=150&type=chunk)[151](index=151&type=chunk) [General and Administrative](index=36&type=section&id=General%20and%20Administrative) Discusses the increase in general and administrative expenses, mainly driven by higher personnel costs General and Administrative Expenses (in thousands of US dollars) | 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 | | :--- | :--- | :--- | :--- | :--- | | General and administrative expenses | $7,709 | $5,514 | $15,551 | $11,392 | - General and administrative expenses increased by **$2.2 million** and **$4.2 million** for the three and six-month periods, respectively, primarily due to increased personnel costs, including share-based compensation[153](index=153&type=chunk) [Liquidity and Capital Resources](index=36&type=section&id=Liquidity%20and%20Capital%20Resources) Assesses the company's liquidity position, cash flow trends, and future capital requirements [Cash Flow Summary](index=36&type=section&id=Cash%20Flow%20Summary) Provides a summary of cash flows from operating, investing, and financing activities and their impact on cash and cash equivalents Cash Flow Summary (in thousands of US dollars) | Metric | 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) provided by 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) | - Cash outflow from operating activities increased by **$46.5 million**, primarily due to changes in operating assets and liabilities and an increased net loss[154](index=154&type=chunk) - Cash outflow from investing activities decreased by **$49.3 million**, mainly due to increased maturities of short-term investments, decreased purchases of short-term investments, and reduced increases in property and equipment[155](index=155&type=chunk) - Cash inflow from financing activities decreased by **$278.3 million**, primarily due to reduced proceeds from capital market transactions compared to the prior year[156](index=156&type=chunk) [Sources of Liquidity](index=38&type=section&id=Sources%20of%20Liquidity) Details the various capital market transactions and agreements that have provided liquidity to the company - 2024 ATM Agreement: On February 18, 2025, the company sold **3,379,377** shares of common stock through this agreement, generating gross proceeds of approximately **$10.2 million**[162](index=162&type=chunk) - May 2024 Registered Offering: Generated gross proceeds of approximately **$80 million**, involving the issuance of common stock and pre-funded warrants, with all pre-funded warrants exercised in the second quarter of 2025[163](index=163&type=chunk)[164](index=164&type=chunk)[165](index=165&type=chunk) - March 2024 Institutional Investor Private Placement: Generated gross proceeds of approximately **$87.4 million**, involving the issuance of **9,200,998** shares of common stock[166](index=166&type=chunk) - Lantheus Investment Agreement: The company sold **5,634,235** shares of common stock to Lantheus, representing **19.99%** of its outstanding common stock as of January 8, 2024[167](index=167&type=chunk) - January 2024 Public Offering: Generated gross proceeds of approximately **$69 million**, involving the issuance of common stock and pre-funded warrants, with all pre-funded warrants exercised in the fourth quarter of 2024[168](index=168&type=chunk)[169](index=169&type=chunk)[170](index=170&type=chunk) - 2023 ATM Agreement: On April 11, 2024, common stock was sold, generating gross proceeds of approximately **$49.5 million**[171](index=171&type=chunk) [Funding Requirements](index=42&type=section&id=Funding%20Requirements) Discusses the company's future capital needs, potential financing methods, and factors influencing these requirements - The company expects its cash, cash equivalents, and short-term investments (totaling **$191.6 million** as of June 30, 2025) to be sufficient to support its currently planned clinical milestones and operating investments through the end of 2026[172](index=172&type=chunk) - The company anticipates needing to raise additional capital before achieving profitability, potentially through equity financing, debt financing, strategic collaborations, or licensing agreements[173](index=173&type=chunk)[177](index=177&type=chunk) - Future funding requirements will depend on various factors, including the scope of research and development, regulatory approvals, employee recruitment, intellectual property maintenance, acquisition or licensing of other product candidates, and trade policies[175](index=175&type=chunk)[176](index=176&type=chunk) [Capital expenditures](index=44&type=section&id=Capital%20expenditures) Explains management's approach to capital allocation for research and development, general and administrative functions, clinical trials, and product supply - Management regularly reviews research and development and general and administrative functions to effectively allocate capital in support of clinical trials, preclinical activities, and product supply[178](index=178&type=chunk) [Financing activities](index=44&type=section&id=Financing%20activities) Outlines the expected sources for financing future capital needs, including equity sales, strategic collaborations, and debt financing - Future capital needs are expected to be financed through equity sales, strategic collaborations, debt financing, or other sources that may dilute existing stockholders' equity[179](index=179&type=chunk) [Other Commitments and Contingencies](index=44&type=section&id=Other%20Commitments%20and%20Contingencies) States that there have been no significant changes to other commitments and contingencies beyond those disclosed in the financial statements - Except as disclosed in Note 10 to the financial statements, there have been no significant changes to other commitments and contingencies as of June 30, 2025[180](index=180&type=chunk) [Off-Balance Sheet Arrangements](index=44&type=section&id=Off-Balance%20Sheet%20Arrangements) Confirms that 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%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) As a smaller reporting company, Perspective Therapeutics, Inc. is not required to provide quantitative and qualitative disclosures about market risk - As a smaller reporting company, the company 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%20Controls%20and%20Procedures) Management assessed the effectiveness of the company's disclosure controls and procedures as of June 30, 2025, concluding they are effective, with no material changes to internal controls during the quarter - As of June 30, 2025, the company's disclosure controls and procedures were determined to be effective in design and operation[183](index=183&type=chunk) - No changes in internal control over financial reporting occurred during the quarter that materially affected or are reasonably likely to materially affect internal control[184](index=184&type=chunk) [PART II OTHER INFORMATION](index=46&type=section&id=PART%20II%20OTHER%20INFORMATION) This section provides additional information not covered in Part I, including legal proceedings, risk factors, equity sales, defaults, and exhibits [Item 1 Legal Proceedings](index=46&type=section&id=Item%201%20Legal%20Proceedings) The company is not currently involved in any material legal proceedings and has no pending or threatened litigation that would significantly impact its business or financial condition - The company is not currently involved in any material legal proceedings[185](index=185&type=chunk) [Item 1A Risk Factors](index=46&type=section&id=Item%201A%20Risk%20Factors) There have been no material changes to the risk factors disclosed in the company's 2024 Form 10-K annual report, which investors should carefully consider - There have been no material changes to the risk factors disclosed in the 2024 Form 10-K annual report[186](index=186&type=chunk) [Item 2 Unregistered Sales of Equity Securities and Use of Proceeds](index=46&type=section&id=Item%202%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) There were no unregistered sales of equity securities or use of proceeds during this quarter - No unregistered sales of equity securities and use of proceeds[187](index=187&type=chunk) [Item 3 Defaults Upon Senior Securities](index=46&type=section&id=Item%203%20Defaults%20Upon%20Senior%20Securities) There were no defaults upon senior securities during this quarter - No defaults upon senior securities[188](index=188&type=chunk) [Item 4 Mine Safety Disclosures](index=46&type=section&id=Item%204%20Mine%20Safety%20Disclosures) This item is 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%20Other%20Information) No Rule 10b5-1 trading arrangements were adopted, modified, or terminated by the company's directors or officers during this quarter - No "Rule 10b5-1 trading arrangements" or "non-Rule 10b5-1 trading arrangements" were adopted, modified, or terminated by the company's directors or officers during this quarter[190](index=190&type=chunk) [Item 6 Exhibits](index=47&type=section&id=Item%206%20Exhibits) This section lists all exhibits filed with this report, including corporate charters, certification documents, and XBRL data files - Exhibits include corporate charters, certification documents (e.g., CEO and CFO certifications), and Inline XBRL files[192](index=192&type=chunk) [Signatures](index=48&type=section&id=Signatures) This section contains the official signatures of the company's authorized officers, certifying the accuracy and completeness of the report [Report Signatures](index=48&type=section&id=Report%20Signatures) This report was officially signed by Perspective Therapeutics, Inc.'s CEO, Johan (Thijs) Spoor, and CFO, Juan Graham, on August 13, 2025 - The report was signed on August 13, 2025[194](index=194&type=chunk) - Signatories include CEO Johan (Thijs) Spoor and CFO Juan Graham[194](index=194&type=chunk)

Exhibit 99.1 Sanara MedTech Inc. Reports Second Quarter 2025 Financial Results (Unaudited) Net Revenue Increased 28% Year-Over-Year in Q2; Increased 27% Year-Over-Year in First Six Months of 2025 Announces Process to Evaluate Strategic Alternatives for its Tissue Health Plus, LLC Subsidiary FORT WORTH, TX, August 13, 2025 (GLOBE NEWSWIRE) - Sanara MedTech Inc. ("Sanara," the "Company," "we," "our" or "us") (Nasdaq: SMTI), a medical technology company focused on developing and commercializing transformative ...

[Executive Summary & Recent Developments](index=1&type=section&id=1.%20Executive%20Summary%20%26%20Recent%20Developments) [Company Overview](index=1&type=section&id=1.1%20Company%20Overview) ProMIS Neurosciences Inc. is a clinical-stage biotechnology company focused on developing antibody therapies for misfolded toxic proteins in neurodegenerative diseases, including Alzheimer's, ALS, and Parkinson's disease - ProMIS Neurosciences Inc. is a clinical-stage biotechnology company focused on generating and developing antibody therapies for misfolded toxic proteins in neurodegenerative diseases such as Alzheimer's disease, amyotrophic lateral sclerosis, and Parkinson's disease[1](index=1&type=chunk) [Key Corporate Highlights](index=1&type=section&id=1.2%20Key%20Corporate%20Highlights) ProMIS Neurosciences achieved significant progress in Q2 2025 and July, including PMN310's FDA Fast Track designation, over 50% patient enrollment in PRECISE-AD Phase 1b trial with good safety, and strengthened financial position through financing - The US FDA granted **Fast Track designation** for PMN310 in Alzheimer's disease, enhancing its potential for priority review[1](index=1&type=chunk)[2](index=2&type=chunk) - The PRECISE-AD Phase 1b Alzheimer's disease trial is on track, with **over 50% patient enrollment** and no ARIA cases or patient withdrawals observed to date, reinforcing PMN310's potentially favorable safety profile[1](index=1&type=chunk)[2](index=2&type=chunk) - Financing in July 2025 generated **$21.6 million in gross proceeds**, strengthening the financial position[1](index=1&type=chunk)[2](index=2&type=chunk) [Research & Development Programs](index=1&type=section&id=2.%20Research%20%26%20Development%20Programs) [EpiSelect™ Drug Discovery Engine](index=1&type=section&id=2.1%20EpiSelect%E2%84%A2%20Drug%20Discovery%20Engine) ProMIS's proprietary EpiSelect™ platform identifies uniquely exposed conformational epitopes on toxic misfolded proteins, generating highly selective antibodies or vaccine formulations to avoid off-target effects, successfully applied to PMN310 and candidates for α-synuclein and TDP-43 - EpiSelect™ is a computational platform used to identify uniquely exposed conformational epitopes on toxic misfolded proteins, enabling the generation of misfolding-specific antibody or vaccine formulations[3](index=3&type=chunk) - The platform generated PMN310, a clinical-stage humanized monoclonal antibody candidate, highly selective for **toxic amyloid-beta oligomers (AβO)** with no significant reactivity to amyloid-beta monomers or fibrils, thereby avoiding off-target effects and reducing the risk of ARIA (brain edema and microhemorrhages)[3](index=3&type=chunk) - Specific epitopes for α-synuclein toxic oligomers/soluble fibrils driving synucleinopathies, and for pathogenic TDP-43 in ALS/FTD, have been identified, with lead antibody candidates generated[3](index=3&type=chunk)[4](index=4&type=chunk) [Alzheimer's Disease Program (PMN310)](index=3&type=section&id=2.2%20Alzheimer's%20Disease%20Program%20(PMN310)) PMN310 is ProMIS's lead candidate for Alzheimer's disease, a humanized IgG1 antibody designed to selectively target toxic AβO, aiming to reduce ARIA risk and enhance efficacy, with significant progress in clinical trials and regulatory milestones - PMN310 is the company's lead candidate for AD, a potential best-in-class humanized monoclonal antibody designed to selectively target toxic oligomers while avoiding plaques, potentially reducing or eliminating ARIA risk and improving safety[10](index=10&type=chunk) [PRECISE-AD Phase 1b Trial Progress & Safety](index=1&type=section&id=2.2.1%20PRECISE-AD%20Phase%201b%20Trial%20Progress%20%26%20Safety) The PRECISE-AD Phase 1b Alzheimer's trial is progressing well, with over 50% patient enrollment and no ARIA cases or withdrawals reported to date, demonstrating PMN310's favorable safety profile; the DSMB recommended continuing the trial and advancing to the next dose level - As of August 12, 2025, the PRECISE-AD Phase 1b Alzheimer's disease trial has enrolled **over 50% of the planned 128 patients**[2](index=2&type=chunk)[5](index=5&type=chunk) - No amyloid-related imaging abnormalities (ARIA) cases, including brain edema or microhemorrhages, or patient withdrawals have been observed to date[2](index=2&type=chunk)[5](index=5&type=chunk) - In May 2025, the DSMB recommended the trial continue as planned without modifications and approved advancing from the first cohort's 5mg/kg dose to the second cohort's 10mg/kg dose[5](index=5&type=chunk) [Regulatory Milestones & Biomarker Insights](index=1&type=section&id=2.2.2%20Regulatory%20Milestones%20%26%20Biomarker%20Insights) PMN310 received FDA Fast Track designation in July 2025; studies indicate plasma pT217 or pT181 as biomarkers have three times the effect size of clinical outcome CDR-SB, suggesting higher trial power or smaller sample sizes; 6-month blinded interim results for PMN310 are expected in Q2 2026, with final topline results in Q4 2026 - In July 2025, PMN310 received **FDA Fast Track designation**[2](index=2&type=chunk)[5](index=5&type=chunk)[10](index=10&type=chunk) Biomarker vs. Clinical Outcome Effect Size Comparison | Metric | Cohen's d Effect Size | | :------------------- | :------------------- | | Plasma pT217 or pT181 | Three times that of clinical outcome CDR-SB | | Clinical Outcome CDR-SB | Baseline | - The group-level correlation between plasma pT217 or pT181 and clinical outcome CDR-SB is approximately **0.786**, with a p-value of **0.036**[12](index=12&type=chunk) - ProMIS expects to report 6-month blinded interim results for PRECISE-AD in **Q2 2026**, with topline results anticipated in **Q4 2026**[2](index=2&type=chunk)[12](index=12&type=chunk) [Alzheimer's Disease Vaccine Program (PMN311)](index=5&type=section&id=2.3%20Alzheimer's%20Disease%20Vaccine%20Program%20(PMN311)) ProMIS is advancing the development of its PMN311 Aβ vaccine program for Alzheimer's disease, based on its oligomer-targeting epitopes - ProMIS continues to advance its PMN311 Aβ vaccine program in AD, based on its oligomer-targeting epitopes[6](index=6&type=chunk) [Other Neurodegenerative Disease Programs](index=5&type=section&id=2.4%20Other%20Neurodegenerative%20Disease%20Programs) ProMIS is developing candidates for Parkinson's disease, Multiple System Atrophy, and Amyotrophic Lateral Sclerosis, with PMN442 and PMN267 ready for IND-enabling studies [Parkinson's Disease and Multiple System Atrophy (PMN442)](index=5&type=section&id=2.4.1%20Parkinson's%20Disease%20and%20Multiple%20System%20Atrophy%20(PMN442)) PMN442 is ProMIS's lead candidate for Parkinson's disease, Multiple System Atrophy, and other synucleinopathies, a humanized IgG1 antibody with selective binding and protective activity against pathogenic α-synuclein, ready for IND-enabling studies - PMN442 is ProMIS's lead candidate for PD, MSA, and other synucleinopathies, a humanized IgG1 antibody based on its selective binding and protective activity against pathogenic α-synuclein[7](index=7&type=chunk) - PMN442 is ready for **IND-enabling studies**[7](index=7&type=chunk) [Amyotrophic Lateral Sclerosis (PMN267)](index=5&type=section&id=2.4.2%20Amyotrophic%20Lateral%20Sclerosis%20(PMN267)) PMN267 is a humanized IgG1 antibody targeting toxic misfolded TDP-43, considered a potential therapeutic target for ALS, and is currently ready for IND-enabling studies - PMN267 is a humanized IgG1 antibody targeting toxic misfolded TDP-43, a potential therapeutic target for ALS[12](index=12&type=chunk) - PMN267 is ready for **IND-enabling studies**[12](index=12&type=chunk) [Financial Performance](index=5&type=section&id=3.%20Financial%20Performance) [Second Quarter 2025 Financial Highlights](index=5&type=section&id=3.1%20Second%20Quarter%202025%20Financial%20Highlights) ProMIS saw significant year-over-year increases in Q2 2025 R&D expenses and net loss, primarily due to PRECISE-AD Phase 1b trial expenditures, while raising $21.6 million in gross proceeds through multiple transactions in July 2025, substantially strengthening its cash position Key Financial Data for Q2 2025 (Year-over-Year) | Metric | Q2 2025 | Q2 2024 | YoY Change | | :------------------- | :---------- | :---------- | :----------- | | Cash and Cash Equivalents | $4.5 million | $1.0 million | +$3.5 million | | Research and Development Expenses | $8.7 million | $1.6 million | +$7.1 million | | General and Administrative Expenses | $1.4 million | $1.1 million | +$0.3 million | | Net Loss | $(10.1) million | $(2.6) million | $(7.5) million | - The net loss was primarily attributable to increased expenditures for the PMN310 PRECISE-AD Phase 1b trial[13](index=13&type=chunk) - In July 2025, ProMIS obtained **$21.6 million in gross proceeds** through a registered direct offering, private placement, and warrant exercises[2](index=2&type=chunk)[13](index=13&type=chunk) [Consolidated Balance Sheets](index=8&type=section&id=3.2%20Consolidated%20Balance%20Sheets) As of June 30, 2025, ProMIS's total assets and cash balance significantly decreased from December 31, 2024, while total liabilities substantially increased, resulting in a negative total shareholders' (deficit) equity, reflecting changes in financial position due to clinical trial investments and operating losses Selected Consolidated Balance Sheet Items (As of June 30, 2025 vs. December 31, 2024) | Item | June 30, 2025 | December 31, 2024 | Change | | :--------------------------- | :------------ | :----------- | :------- | | Cash | $4,510,119 | $13,291,167 | $(8,781,048) | | Total Current Assets | $9,509,496 | $18,911,456 | $(9,401,960) | | Total Current Liabilities | $9,824,087 | $2,218,425 | +$7,605,662 | | Total Liabilities | $9,892,074 | $2,423,280 | +$7,468,794 | | Accumulated Deficit | $(108,152,005) | $(90,687,073) | $(17,464,932) | | Total Shareholders' (Deficit) Equity | $(382,578) | $16,488,176 | $(16,870,754) | [Consolidated Statements of Operations](index=9&type=section&id=3.3%20Consolidated%20Statements%20of%20Operations) In Q2 and H1 2025, ProMIS's R&D and total operating expenses significantly increased year-over-year, leading to a substantial expansion in net loss and net loss per share, primarily reflecting increased investment in clinical trials Selected Consolidated Statements of Operations Items (Q2 2025 vs. Q2 2024) | Item | Q2 2025 | Q2 2024 | YoY Change | | :--------------------------- | :---------- | :---------- | :----------- | | Research and Development Expenses | $8,749,784 | $1,625,821 | +$7,123,963 | | General and Administrative Expenses | $1,434,877 | $1,087,885 | +$346,992 | | Total Operating Expenses | $10,184,661 | $2,713,706 | +$7,470,955 | | Net Loss | $(10,117,029) | $(2,623,657) | $(7,493,372) | | Net Loss Per Share (Basic and Diluted) | $(0.29) | $(0.13) | $(0.16) | Selected Consolidated Statements of Operations Items (Six Months Ended June 30, 2025 vs. Six Months Ended June 30, 2024) | Item | H1 2025 | H1 2024 | YoY Change | | :--------------------------- | :---------- | :---------- | :----------- | | Research and Development Expenses | $14,214,034 | $3,749,599 | +$10,464,435 | | General and Administrative Expenses | $3,430,723 | $2,640,758 | +$789,965 | | Total Operating Expenses | $17,644,757 | $6,390,357 | +$11,254,400 | | Net Loss | $(17,464,932) | $(6,258,745) | $(11,206,187) | | Net Loss Per Share (Basic and Diluted) | $(0.50) | $(0.32) | $(0.18) | [Company and Product Information](index=5&type=section&id=4.%20Company%20and%20Product%20Information) [About ProMIS Neurosciences Inc.](index=5&type=section&id=4.1%20About%20ProMIS%20Neurosciences%20Inc.) ProMIS Neurosciences is a clinical-stage biotechnology company dedicated to discovering and developing therapeutic antibodies and vaccines targeting toxic oligomers in neurodegenerative and other misfolded protein diseases, utilizing its proprietary EpiSelect™ target discovery engine to identify disease-specific epitopes - ProMIS Neurosciences is a clinical-stage biotechnology company focused on discovering and developing therapeutic antibodies and vaccines targeting toxic oligomers in neurodegenerative and other misfolded protein diseases[9](index=9&type=chunk) - The company's proprietary target discovery engine, EpiSelect™, has been shown to predict novel disease-specific epitopes (DSEs) on the surface of misfolded protein molecules that cause neurodegenerative and other misfolded protein diseases, including AD, ALS, FTD, MSA, and PD[9](index=9&type=chunk) [About PMN310](index=5&type=section&id=4.2%20About%20PMN310) PMN310 is ProMIS's lead candidate for Alzheimer's disease, a potential best-in-class humanized monoclonal antibody designed to selectively target toxic oligomers while avoiding plaques, potentially reducing or eliminating ARIA risk and improving safety; PMN310 received FDA Fast Track designation in July 2025 - PMN310 is the company's lead candidate for AD, a potential best-in-class humanized monoclonal antibody designed to selectively target toxic oligomers while avoiding plaques, potentially reducing or eliminating ARIA risk and improving safety[10](index=10&type=chunk) - PMN310 received **FDA Fast Track designation** in July 2025[10](index=10&type=chunk) [Forward-Looking Statements](index=5&type=section&id=5.%20Forward-Looking%20Statements) [Forward-Looking Statements](index=5&type=section&id=5.1%20Forward-Looking%20Statements) This press release contains forward-looking statements regarding future events, expectations, and projections, including clinical trial results, pipeline progress, and financial outlook; these statements are based on management's current expectations, assumptions, and estimates, but are subject to known and unknown risks, uncertainties, and other factors that may cause actual results to differ materially from forward-looking information, particularly that preclinical or early clinical results may not be indicative, and regarding the company's ability to continue as a going concern - This press release contains forward-looking information regarding the company's Phase 1b study in AD patients and expected results (including interim results in **H1 2026** and topline results by **end of 2026**), potential benefits of PMN310, pipeline progress, timing of IND-enabling studies, future financial results, and ability to continue as a going concern[11](index=11&type=chunk)[14](index=14&type=chunk) - Forward-looking information is necessarily based on a number of opinions, assumptions, and estimates that, while considered reasonable by the company as of the date of the press release, are subject to known and unknown risks, uncertainties, and other factors that may cause the actual results, level of activity, performance, or achievements to be materially different from those expressed or implied by such forward-looking information[14](index=14&type=chunk) - Important factors that could cause actual results to differ materially from forward-looking information include that preclinical or early clinical results may not be indicative, the company's ability to fund its operations and continue as a going concern, and its accumulated deficit and expectation of ongoing losses[14](index=14&type=chunk) [Contact Information](index=7&type=section&id=6.%20Contact%20Information) [Contact Information](index=7&type=section&id=6.1%20Contact%20Information) This section provides contact details for ProMIS Neurosciences, including the company website, media inquiries email, and investor relations contact - Company Website: **www.promisneurosciences.com**[15](index=15&type=chunk) - Media Inquiries: **info@promisneurosciences.com**[15](index=15&type=chunk) - Investor Relations Contact: **Kaytee Bock Zafereo (katherine.bock@promisneurosciences.com)**[15](index=15&type=chunk)

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2025 For the transition period from to Commission File Number 001-39756 If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to S ...