PART I. FINANCIAL INFORMATION [Item 1. Financial Statements](index=3&type=section&id=Item%201.%20Financial%20Statements) Unaudited H1 2025 financials report a **$63.3 million net loss**, increased accumulated deficit, and a **going concern warning** [Balance Sheets](index=3&type=section&id=Balance%20Sheets) Balance Sheet Summary (Unaudited) | (in thousands) | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $25,752 | $12,474 | | Marketable securities | $47,464 | $121,140 | | Total current assets | $76,876 | $135,895 | | **Total assets** | **$114,918** | **$175,515** | | **Liabilities & Stockholders' Equity** | | | | Total current liabilities | $20,908 | $25,641 | | **Total liabilities** | **$39,080** | **$44,056** | | Accumulated deficit | ($646,879) | ($583,563) | | **Total stockholders' equity** | **$75,838** | **$131,459** | [Statements of Operations and Comprehensive Loss](index=4&type=section&id=Statements%20of%20Operations%20and%20Comprehensive%20Loss) Statement of Operations Summary (Unaudited) | (in thousands, except per share data) | 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 | $25,784 | $29,509 | $54,600 | $56,918 | | General and administrative | $6,410 | $7,655 | $12,200 | $14,589 | | **Loss from operations** | **($32,194)** | **($37,164)** | **($66,800)** | **($71,507)** | | **Net loss** | **($31,231)** | **($34,740)** | **($63,316)** | **($66,171)** | | Net loss per share, basic and diluted | ($0.41) | ($0.46) | ($0.83) | ($0.87) | [Statements of Cash Flows](index=7&type=section&id=Statements%20of%20Cash%20Flows) Cash Flow Summary (Unaudited) | (in thousands) | Six months ended June 30, 2025 | Six months ended June 30, 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | ($60,306) | ($54,848) | | Net cash provided by investing activities | $73,707 | $57,340 | | Net cash (used in) provided by financing activities | ($123) | $45 | | **Net increase in cash, cash equivalents and restricted cash** | **$13,278** | **$2,537** | [Notes to Unaudited Interim Financial Statements](index=8&type=section&id=Notes%20to%20Unaudited%20Interim%20Financial%20Statements) Notes detail accounting policies, a **going concern warning**, R&D expenses, workforce reduction, and collaboration agreements - The Company has incurred operating losses since inception, with an accumulated deficit of **$646.9 million** as of June 30, 2025[28](index=28&type=chunk) - Management has concluded that **substantial doubt exists about the Company's ability to continue as a going concern**, as its cash, cash equivalents, and marketable securities of **$77.3 million** are not sufficient to fund operations for at least the next twelve months[29](index=29&type=chunk) - In May 2024, the Company entered into a license agreement with Pathos AI, Inc. for its PRMT5 inhibitor, PRT811, receiving a **$3.0 million upfront payment** All performance obligations were satisfied in the second half of 2024[68](index=68&type=chunk)[71](index=71&type=chunk) Research and Development Expenses by Program (Six Months Ended June 30) | (in thousands) | 2025 | 2024 | | :--- | :--- | :--- | | PRT3789 | $8,268 | $8,875 | | PRT7732 | $5,736 | $— | | Discovery programs | $5,756 | $10,603 | | Other | $2,701 | $6,143 | | General costs, including personnel related | $32,139 | $31,297 | | **Total research and development** | **$54,600** | **$56,918** | - During the second quarter of 2025, the Company reduced its workforce by approximately **11%**, incurring one-time costs of **$0.5 million**[88](index=88&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=26&type=section&id=Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses clinical pipeline, Q2/H1 2025 operating expense decreases, liquidity, and Nasdaq delisting [Overview](index=26&type=section&id=Overview) - The company is a clinical-stage precision oncology company with a pipeline including PRT3789 (SMARCA2 degrader), PRT7732 (oral SMARCA2 degrader), precision ADC programs, and KAT6A selective degraders[91](index=91&type=chunk)[94](index=94&type=chunk)[96](index=96&type=chunk)[103](index=103&type=chunk) - PRT3789 has completed Phase 1, with updated data expected by **year-end 2025** A Phase 2 trial in combination with KEYTRUDA is ongoing[95](index=95&type=chunk) - The oral SMARCA2 degrader, PRT7732, is advancing rapidly in a Phase 1 trial, with an initial data update expected by **year-end 2025**[97](index=97&type=chunk) - On March 27, 2025, the company received a **delisting notice from Nasdaq** for failing to maintain a minimum bid price of **$1.00 per share** The company has until September 23, 2025, to regain compliance[105](index=105&type=chunk)[107](index=107&type=chunk) [Results of Operations](index=32&type=section&id=Results%20of%20Operations) Comparison of Operating Results (Three Months Ended June 30) | (in thousands) | 2025 | 2024 | Change | | :--- | :--- | :--- | :--- | | Research and development | $25,784 | $29,509 | ($3,725) | | General and administrative | $6,410 | $7,655 | ($1,245) | | **Total operating expenses** | **$32,194** | **$37,164** | **($4,970)** | | **Net loss** | **($31,231)** | **($34,740)** | **$3,509** | - The decrease in R&D and G&A expenses for Q2 2025 was primarily driven by lower non-cash stock-based compensation expense and a decrease in expenses related to SMARCA2 clinical trials[122](index=122&type=chunk)[125](index=125&type=chunk) Comparison of Operating Results (Six Months Ended June 30) | (in thousands) | 2025 | 2024 | Change | | :--- | :--- | :--- | :--- | | Research and development | $54,600 | $56,918 | ($2,318) | | General and administrative | $12,200 | $14,589 | ($2,389) | | **Total operating expenses** | **$66,800** | **$71,507** | **($4,707)** | | **Net loss** | **($63,316)** | **($66,171)** | **$2,855** | [Liquidity and Capital Resources](index=36&type=section&id=Liquidity%20and%20Capital%20Resources) - As of June 30, 2025, the company had **$77.3 million** in cash, cash equivalents, restricted cash, and marketable securities[136](index=136&type=chunk) - The company states that its current cash position is **not sufficient to fund operating expenses and capital requirements for at least the next twelve months**, raising **substantial doubt about its ability to continue as a going concern**[136](index=136&type=chunk) - The company has a **$400 million effective shelf registration statement** and a **$75 million Open Market Sales Agreement (ATM facility)** in place to potentially raise additional capital[140](index=140&type=chunk)[141](index=141&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=41&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) As a smaller reporting company, no market risk disclosures are required for this item - As a smaller reporting company, Prelude Therapeutics is **not required to provide quantitative and qualitative disclosures about market risk**[155](index=155&type=chunk) [Controls and Procedures](index=41&type=section&id=Item%204.%20Controls%20and%20Procedures) Management confirmed effective disclosure controls and procedures with no material changes to internal controls - Management concluded that the company's disclosure controls and procedures were **effective** as of June 30, 2025[156](index=156&type=chunk) - There were **no changes in internal control over financial reporting** during the quarter that have materially affected, or are reasonably likely to materially affect, internal controls[157](index=157&type=chunk) PART II. OTHER INFORMATION [Legal Proceedings](index=42&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently involved in any material legal proceedings - The company reports **no material legal proceedings**[160](index=160&type=chunk) [Risk Factors](index=42&type=section&id=Item%201A.%20Risk%20Factors) Key risks include potential Nasdaq delisting and substantial doubt about the company's going concern ability - A significant risk is the **potential delisting from Nasdaq** The company received a non-compliance notice on March 27, 2025, for its stock price falling below the **$1.00 minimum bid requirement**[162](index=162&type=chunk)[163](index=163&type=chunk) - The company has until **September 23, 2025**, to regain compliance with Nasdaq's minimum bid price rule, after which it may be eligible for an extension[164](index=164&type=chunk) - The financial statements contain a **'going concern' warning**, indicating **substantial doubt about the company's ability to continue operations** as its current cash will not be sufficient to fund operations for at least the next twelve months[167](index=167&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=44&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) No unregistered sales of equity securities were reported during the period - **None reported**[169](index=169&type=chunk) [Exhibits](index=45&type=section&id=Item%206.%20Exhibits) This section lists filed exhibits, including corporate documents, officer certifications, and XBRL data files

PART I - FINANCIAL INFORMATION [Item 1. Financial Statements](index=4&type=section&id=Item%201.%20FINANCIAL%20STATEMENTS) The company presents its unaudited condensed consolidated financial statements for the three and six months ended June 30, 2025, showing significant improvement in net income and gross margin driven by higher sales and better cost management [Condensed Consolidated Balance Sheets](index=4&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) As of June 30, 2025, total assets increased to **$60.4 million** from **$51.5 million** at year-end 2024, with total stockholders' equity growing significantly to **$36.8 million** from **$29.8 million** | Balance Sheet Items (In thousands) | June 30, 2025 (Unaudited) | December 31, 2024 | | :--- | :--- | :--- | | **Current Assets** | | | | Cash and cash equivalents | $11,853 | $7,075 | | Trade accounts receivable, net | $11,542 | $7,349 | | Inventories, net | $17,167 | $17,636 | | Total current assets | $44,833 | $36,941 | | **Total Assets** | **$60,426** | **$51,499** | | **Current Liabilities** | | | | Accounts payable | $9,835 | $6,327 | | Total current liabilities | $15,920 | $13,974 | | **Total Liabilities** | **$23,663** | **$21,668** | | **Total Stockholders' Equity** | **$36,763** | **$29,831** | [Condensed Consolidated Statements of Operations](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) For Q2 2025, sales increased to **$21.2 million** from **$20.3 million** year-over-year, with gross margin improving to **47.4%** from **37.3%**, leading to net income more than doubling to **$3.7 million** or **$0.96 per diluted share** | Income Statement (In thousands) | Q2 2025 | Q2 2024 | YTD 2025 | YTD 2024 | | :--- | :--- | :--- | :--- | :--- | | Sales, net | $21,165 | $20,254 | $40,219 | $38,485 | | Gross margin | $10,035 | $7,547 | $18,985 | $13,835 | | Operating income | $3,997 | $2,025 | $6,913 | $3,008 | | Net income | $3,741 | $1,664 | $5,873 | $2,345 | | Net income per share-diluted | $0.96 | $0.47 | $1.51 | $0.66 | [Condensed Consolidated Statements of Cash Flows](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Net cash provided by operating activities significantly increased to **$6.0 million** for the first six months of 2025, contributing to a rise in cash and cash equivalents to **$11.9 million** | Cash Flow (In thousands) | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--- | :--- | :--- | | Net cash provided by operating activities | $6,002 | $3,311 | | Net cash used in investing activities | ($1,465) | ($848) | | Net cash provided by (used in) financing activities | $241 | ($2,938) | | **Net change in cash and cash equivalents** | **$4,778** | **($475)** | | **Cash and cash equivalents, end of period** | **$11,853** | **$2,981** | [Notes to Condensed Consolidated Financial Statements](index=8&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) The notes detail accounting policies, the expansion of the BK ONE Solutions business, a new **$6 million** credit facility, customer concentration, and subsequent events including stock option grants - The company is expanding its Solutions business unit under the new brand, BK ONE, which includes SaaS solutions like InteropONE and other future software and hardware applications[37](index=37&type=chunk) - Sales to U.S. government agencies were **11.5%** of total net sales for the first six months of 2025, down from **41.5%** in the same period last year, while two commercial customers accounted for **26.6%** of net sales in the first half of 2025[62](index=62&type=chunk) - The company entered into a new one-year revolving line of credit for up to **$6 million** with Fifth Third Bank in October 2024, with no borrowings under this facility as of June 30, 2025[38](index=38&type=chunk)[64](index=64&type=chunk) - Subsequent to the quarter end, the company granted performance-based stock options for executives and issued shares related to RSU grants upon achieving revenue milestones for the BKR9000 radio[75](index=75&type=chunk)[76](index=76&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations (MD&A)](index=20&type=section&id=Item%202.%20MANAGEMENT%27S%20DISCUSSION%20AND%20ANALYSIS%20OF%20FINANCIAL%20CONDITION%20AND%20RESULTS%20OF%20OPERATIONS) Management discusses Q2 2025 financial results, highlighting a **4.5%** YoY sales increase to **$21.2 million**, significant gross margin improvement to **47.4%**, and nearly doubled operating income, alongside improved liquidity and an undrawn **$6.0 million** credit facility [Executive Summary](index=21&type=section&id=Executive%20Summary) Q2 2025 sales rose **4.5%** YoY to **$21.2 million**, driven by BKR series radio shipments, with gross margin expanding significantly to **47.4%** and net income increasing substantially to **$3.7 million** or **$0.96 per diluted share** - The backlog of unshipped customer orders was approximately **$16.0 million** as of June 30, 2025, compared to **$21.8 million** as of December 31, 2024[89](index=89&type=chunk) | Key Metrics (Q2 2025 vs Q2 2024) | Q2 2025 | Q2 2024 | Change | | :--- | :--- | :--- | :--- | | Sales | ~$21.2M | ~$20.3M | +4.5% | | Gross Profit Margin | 47.4% | 37.3% | +10.1 ppt | | Operating Income | ~$4.0M | ~$2.0M | +100% | | Net Income | ~$3.7M | ~$1.7M | +118% | | Diluted EPS | $0.96 | $0.47 | +104% | [Results of Operations](index=23&type=section&id=Results%20of%20Operations) Net sales for Q2 2025 increased by **4.5%** to **$21.2 million** due to strong BKR series radio sales, while gross profit margin rose to **47.4%** reflecting favorable product mix and manufacturing cost improvements, leading to doubled operating income - The increase in gross profit margins for Q2 and H1 2025 was attributed to a better radio product and accessories sales mix and material cost improvements from transitioning manufacturing to East West Manufacturing, LLC[108](index=108&type=chunk) - SG&A expenses increased by **11.5%** for the six-month period, primarily due to higher engineering and product development costs for the BKR multi-band mobile radio and increased marketing and selling expenses[111](index=111&type=chunk)[112](index=112&type=chunk)[113](index=113&type=chunk) [Liquidity and Capital Resources](index=27&type=section&id=Liquidity%20and%20Capital%20Resources) The company's liquidity strengthened with cash and cash equivalents reaching **$11.9 million** at June 30, 2025, driven by **$6.0 million** in net cash from operations for the first six months, and an undrawn **$6 million** revolving credit facility - Net cash provided by operating activities totaled approximately **$6.0 million** for the first six months of 2025, compared to **$3.3 million** for the same period in 2024[123](index=123&type=chunk) - The company's cash and cash equivalents balance was approximately **$11.9 million** on June 30, 2025[127](index=127&type=chunk) - A Revolving Loan Commitment with Fifth Third Bank provides for a one-year, **$6 million** line of credit (expandable to **$10 million**), which was unused as of the report date[128](index=128&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=29&type=section&id=Item%203.%20QUANTITATIVE%20AND%20QUALITATIVE%20DISCLOSURES%20ABOUT%20MARKET%20RISK) As a "smaller reporting company," the company is not required to provide disclosure under this item - As a "smaller reporting company," the Company is not required to include disclosures about market risk[133](index=133&type=chunk) [Item 4. Controls and Procedures](index=30&type=section&id=Item%204.%20CONTROLS%20AND%20PROCEDURES) Management concluded that the company's disclosure controls and procedures were not effective as of June 30, 2025, due to an un-remediated material weakness in internal control over the income tax provision - The Chief Executive Officer and Chief Financial Officer concluded that the company's disclosure controls and procedures were not effective as of the end of the reporting period[135](index=135&type=chunk) - The ineffectiveness is due to a material weakness in internal control related to the proper design and implementation of controls over the income tax provision[136](index=136&type=chunk) - Management has engaged in implementing a remediation plan, including using third-party assistance and enhancing review processes for complex accounting transactions[138](index=138&type=chunk)[139](index=139&type=chunk) PART II - OTHER INFORMATION [Item 1A. Risk Factors](index=32&type=section&id=Item%201A.%20RISK%20FACTORS) The company highlights a new risk concerning potential adverse effects of changes in U.S. trade policy, including tariffs, which could increase costs, impact the supply chain, and reduce demand due to reliance on foreign electronic components - A specific risk factor has been added regarding changes in U.S. trade policy and tariffs, which could materially affect the business due to its reliance on electronic components from foreign sources[146](index=146&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=33&type=section&id=Item%202.%20UNREGISTERED%20SALES%20OF%20EQUITY%20SECURITIES%20AND%20USE%20OF%20PROCEEDS) This section details the issuance of **89,248** common shares via cashless warrant exercise on May 2, 2025, and confirms no shares were repurchased under the **$5 million** share repurchase program during Q2 2025 - On May 2, 2025, the Company issued **89,248** shares of common stock upon the cashless exercise of a warrant[148](index=148&type=chunk) - No shares were repurchased during the second quarter of 2025 under the company's **$5 million** share repurchase program authorized in December 2021[148](index=148&type=chunk)[150](index=150&type=chunk) [Item 6. Exhibits](index=34&type=section&id=Item%206.%20EXHIBITS) This section provides an index of all exhibits filed with the Form 10-Q, including corporate governance documents, incentive compensation plans, employment agreement amendments, and CEO/CFO certifications - The report includes exhibits such as the 2025 Incentive Compensation Plan, Employee Stock Purchase Plan, amendments to executive employment agreements, and CEO/CFO certifications[155](index=155&type=chunk)

SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (date of earliest event reported): August 14, 2025 AIR INDUSTRIES GROUP (Exact Name of Registrant as Specified in its Charter) | Nevada | 001-35927 | 80-0948413 | | --- | --- | --- | | State of Incorporation | Commission File Number | IRS Employer I.D. Number | | | 1460 Fifth Avenue, Bay Shore, New York 11706 | | | | (Address of Principal Exe ...

Table of Contents 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 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 001-42524 Acuren Corporation (Exact name of registrant as specified in its charter) | | | incorporation or organiza ...

Exhibit 99.1 LAZYDAYS REPORTS SECOND QUARTER 2025 FINANCIAL RESULTS Tampa, FL (August 14, 2025) – Lazydays Holdings, Inc. (NasdaqCM: GORV) ("Lazydays," the "Company" or "we") today reports financial results for the second quarter ended June 30, 2025. Ron Fleming, CEO, said, "We continued to advance our turnaround plan in the second quarter of 2025. Our focus on operational performance resulted in increases in gross profit margins across all products and services compared to the prior year period, and our pu ...

Exhibit 99.1 LAZYDAYS REPORTS SECOND QUARTER 2025 FINANCIAL RESULTS Tampa, FL (August 14, 2025) – Lazydays Holdings, Inc. (NasdaqCM: GORV) ("Lazydays," the "Company" or "we") today reports financial results for the second quarter ended June 30, 2025. Ron Fleming, CEO, said, "We continued to advance our turnaround plan in the second quarter of 2025. Our focus on operational performance resulted in increases in gross profit margins across all products and services compared to the prior year period, and our pu ...

EX-99.1 2 realpha_ex991.htm PRESS RELEASE EXHIBIT 99.1 reAlpha Tech Corp. Announces 1,909% Year-over-Year Revenue Growth for Quarter Ended June 30, 2025 DUBLIN, Ohio, August 14, 2025 (GLOBE NEWSWIRE) -- reAlpha Tech Corp. (Nasdaq: AIRE) (the "Company" or "reAlpha"), an AI-powered real estate technology company, today announced financial results and business highlights for the quarter ended June 30, 2025. Business Highlights · Revenue increased 1,909% to approximately $1.3 million in the second quarter of 20 ...

"The first half of 2025 has been transformational for atai as we continue to advance our mission," stated Srinivas Rao, M.D., Ph.D., Chief Executive Officer and Co-founder of atai. "The planned strategic combination with Beckley Psytech is expected to solidify our position as the global leader in the psychedelic mental health space. By combining our experienced teams and psychedelic expertise as well as adding a late-stage, clinically-validated asset like BPL-003 to our pipeline of wholly owned psychedelic ...

[PART I. FINANCIAL INFORMATION](index=6&type=section&id=PART%20I.%20FINANCIAL%20INFORMATION) Presents Werewolf Therapeutics' unaudited condensed consolidated financial statements and management's discussion for Q2 and H1 2025 [Item 1. Financial Statements](index=6&type=section&id=Item%201.%20Financial%20Statements) Presents Werewolf Therapeutics' unaudited condensed consolidated financial statements for Q2 and H1 2025, showing a net loss and decreased cash [Condensed Consolidated Balance Sheets](index=6&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) Total assets decreased to $92.6 million by June 30, 2025, driven by reduced cash, while equity fell due to net losses Condensed Consolidated Balance Sheet Highlights (in thousands) | Account | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $77,596 | $110,995 | | Total current assets | $80,439 | $113,066 | | Total assets | $92,566 | $126,929 | | **Liabilities & Stockholders' Equity** | | | | Total current liabilities | $15,171 | $15,180 | | Total liabilities | $51,102 | $53,539 | | Accumulated deficit | $(450,659) | $(414,588) | | Total stockholders' equity | $41,464 | $73,390 | [Condensed Consolidated Statements of Operations](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) Net loss for Q2 2025 was $18.0 million, with H1 2025 net loss at $36.1 million, and collaboration revenue at zero Condensed Consolidated Statements of Operations (in thousands, except per share data) | Metric | Q2 2025 | Q2 2024 | H1 2025 | H1 2024 | | :--- | :--- | :--- | :--- | :--- | | Collaboration revenue | $0 | $1,143 | $0 | $1,885 | | Research and development | $13,143 | $15,271 | $26,263 | $28,179 | | General and administrative | $4,399 | $4,832 | $9,270 | $9,828 | | Operating loss | $(17,542) | $(18,960) | $(35,533) | $(36,122) | | Net loss | $(17,982) | $(17,249) | $(36,071) | $(33,442) | | Net loss per share, basic | $(0.40) | $(0.40) | $(0.80) | $(0.79) | [Condensed Consolidated Statements of Stockholders' Equity](index=8&type=section&id=Condensed%20Consolidated%20Statements%20of%20Stockholders'%20Equity) Stockholders' equity decreased from $73.4 million to $41.5 million by June 30, 2025, primarily due to the $36.1 million net loss - Total stockholders' equity declined from **$73.4 million** at December 31, 2024 to **$41.5 million** at June 30, 2025, primarily due to a net loss of **$36.1 million** for the six-month period[26](index=26&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=9&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Net cash used in operating activities increased to $34.1 million in H1 2025, leading to a $33.7 million net decrease in cash Six Months Ended June 30, Cash Flow Summary (in thousands) | Activity | 2025 | 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | $(34,112) | $(29,474) | | Net cash used in investing activities | $0 | $(128) | | Net cash provided by financing activities | $388 | $10,539 | | **Net decrease in cash** | **$(33,724)** | **$(19,063)** | [Notes to Condensed Consolidated Financial Statements](index=10&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) Details accounting policies, the conclusion of the Jazz collaboration, the K2HV loan, and the company's liquidity outlook - The company is an early-stage biopharmaceutical company pioneering therapeutics to stimulate the immune system for cancer treatment[31](index=31&type=chunk) - With **$77.6 million** in cash and cash equivalents as of June 30, 2025, the company expects to fund its operating expenses and capital expenditure requirements for at least the next twelve months, but will require additional funding thereafter[33](index=33&type=chunk) - In June 2024, the company completed its last material performance obligation under the Collaboration Agreement with Jazz Pharmaceuticals, resulting in the recognition of all remaining deferred revenue from that agreement[44](index=44&type=chunk) - In May 2024, the company repaid its loan with Pacific Western Bank and entered into a new loan agreement with K2 HealthVentures (K2HV), drawing down **$30.0 million** in gross proceeds[55](index=55&type=chunk)[56](index=56&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=20&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses financial condition, clinical program updates for WTX-124 and WTX-330, and liquidity, confirming cash sufficiency into Q4 2026 [Overview](index=20&type=section&id=Overview) Werewolf develops conditionally activated immunotherapies, with lead candidates WTX-124 and WTX-330 in Phase 1/1b and Phase 1b/2 trials respectively - The company's most advanced product candidates, WTX-124 (IL-2) and WTX-330 (IL-12), are systemically delivered, conditionally activated INDUKINE molecules for treating various tumor types[91](index=91&type=chunk) - WTX-124 is being evaluated in a Phase 1/1b clinical trial as a monotherapy and in combination with KEYTRUDA, with plans to present interim data from expansion arms in the second half of 2025[92](index=92&type=chunk) - WTX-330 initiated a Phase 1b/2 clinical trial in Q1 2025, with the first patient dosed in Q2 2025 for the treatment of advanced or metastatic solid tumors[93](index=93&type=chunk) [Results of Operations](index=24&type=section&id=Results%20of%20Operations) Q2 2025 saw zero revenue and decreased R&D expenses, while H1 2025 net loss increased to $36.1 million due to lower interest income Comparison of Three Months Ended June 30, (in thousands) | Item | 2025 | 2024 | $ Change | | :--- | :--- | :--- | :--- | | Collaboration revenue | $0 | $1,143 | $(1,143) | | Research and development | $13,143 | $15,271 | $(2,128) | | General and administrative | $4,399 | $4,832 | $(433) | | **Net loss** | **$(17,982)** | **$(17,249)** | **$(733)** | - The **$2.1 million** decrease in Q2 2025 R&D expenses was primarily due to a **$1.8 million** decrease in manufacturing costs for WTX-330 and a **$0.5 million** decrease in personnel costs[116](index=116&type=chunk)[119](index=119&type=chunk) Comparison of Six Months Ended June 30, (in thousands) | Item | 2025 | 2024 | $ Change | | :--- | :--- | :--- | :--- | | Collaboration revenue | $0 | $1,885 | $(1,885) | | Research and development | $26,263 | $28,179 | $(1,916) | | General and administrative | $9,270 | $9,828 | $(558) | | **Net loss** | **$(36,071)** | **$(33,442)** | **$(2,629)** | - The **$1.9 million** decrease in H1 2025 R&D expenses was mainly from a **$2.2 million** reduction in manufacturing costs and a **$0.7 million** decrease in personnel costs, partially offset by a **$0.7 million** increase in clinical trial costs for WTX-124 and WTX-330[126](index=126&type=chunk)[127](index=127&type=chunk) [Liquidity and Capital Resources](index=28&type=section&id=Liquidity%20and%20Capital%20Resources) As of June 30, 2025, the company had $77.6 million in cash, sufficient into Q4 2026, but requires substantial additional funding - As of June 30, 2025, the company had cash and cash equivalents of **$77.6 million**[147](index=147&type=chunk) - Management estimates that existing cash will be sufficient to fund operational expenses and capital expenditure requirements into the fourth quarter of 2026[147](index=147&type=chunk) - The company has an active K2HV Loan Agreement with **$30.0 million** drawn and up to an additional **$20.0 million** available through May 1, 2026, subject to lender consent[139](index=139&type=chunk)[140](index=140&type=chunk) - The company's at-the-market (ATM) offering capacity is limited to an aggregate offering price of up to **$12.5 million** due to the "Baby Shelf Limitation" under Form S-3 rules[145](index=145&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=33&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) As a smaller reporting company, the registrant is exempt from providing market risk disclosures - As a smaller reporting company, the registrant is not required to provide the information for this item[161](index=161&type=chunk) [Item 4. Controls and Procedures](index=33&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded disclosure controls and procedures were effective as of June 30, 2025, with no material changes to internal control over financial reporting - Based on an evaluation as of June 30, 2025, the principal executive officer and principal financial officer concluded that the company's disclosure controls and procedures were effective at the reasonable assurance level[162](index=162&type=chunk) - There were no changes during the most recent fiscal quarter that materially affected, or are reasonably likely to materially affect, the company's internal control over financial reporting[163](index=163&type=chunk) [PART II. OTHER INFORMATION](index=34&type=section&id=PART%20II.%20OTHER%20INFORMATION) Presents other information including significant risk factors and a list of exhibits filed with the Form 10-Q [Item 1A. Risk Factors](index=34&type=section&id=Item%201A.%20Risk%20Factors) Details risks including limited operating history, dependence on early-stage candidates, funding needs, reliance on third parties, and intense competition [Risks Related to Financial Position and Capital Requirements](index=34&type=section&id=Risks%20Related%20to%20Our%20Limited%20Operating%20History,%20Financial%20Position%20and%20Capital%20Requirements) The company faces risks from its limited operating history, accumulated deficit of $450.7 million, ongoing losses, and the need for substantial additional funding - The company has a limited operating history, an accumulated deficit of **$450.7 million** as of June 30, 2025, and expects to incur significant losses for the foreseeable future[166](index=166&type=chunk)[167](index=167&type=chunk) - Substantial additional funding is required to complete the development and commercialization of product candidates, and an inability to raise this capital could force the company to delay, reduce, or eliminate its R&D programs[170](index=170&type=chunk) - The K2HV Loan Agreement contains operating covenants that restrict the company's ability to incur future debt, pay dividends, and dispose of assets, among other limitations[177](index=177&type=chunk) [Risks Related to Discovery, Development, and Commercialization](index=38&type=section&id=Risks%20Related%20to%20the%20Discovery,%20Development,%20Regulatory%20Approval%20and%20Commercialization%20of%20Our%20Product%20Candidates) Business success depends on early-stage candidates and an unproven platform, facing risks in development, manufacturing, and intense competition - The company's business is highly dependent on the success of its initial INDUKINE and INDUCER molecules, which are in early stages of development and require significant additional development[187](index=187&type=chunk) - The PREDATOR platform approach is unproven, and there is no guarantee it will produce commercially valuable products[196](index=196&type=chunk) - Manufacturing the company's novel multi-domain biologics is complex, has never been done at commercial scale, and is subject to risks of delay or failure[200](index=200&type=chunk) - The company faces substantial competition from major pharmaceutical and biotechnology companies developing immunotherapies, including numerous companies developing IL-2 and IL-12 based therapies[238](index=238&type=chunk)[241](index=241&type=chunk)[242](index=242&type=chunk) [Risks Related to Dependence on Third Parties](index=50&type=section&id=Risks%20Related%20to%20Our%20Dependence%20on%20Third%20Parties) Reliance on third-party CROs and CMOs for clinical trials and manufacturing, and a license agreement with Harpoon Therapeutics, poses significant operational risks - The company depends on third-party CROs to conduct preclinical studies and clinical trials and is responsible for ensuring their compliance with regulations like cGCP[259](index=259&type=chunk)[261](index=261&type=chunk) - Without its own clinical manufacturing capabilities, the company relies on third-party CMOs, exposing it to risks of supply disruption, quality issues, and regulatory non-compliance[265](index=265&type=chunk) - The company relies on a license agreement with Harpoon Therapeutics for patent rights essential to its PREDATOR platform and product candidates[285](index=285&type=chunk) [Risks Related to Intellectual Property](index=54&type=section&id=Risks%20Related%20to%20Our%20Intellectual%20Property) Success hinges on obtaining and maintaining patent protection, which is uncertain, and managing risks of infringement claims and trade secret protection - The company's success depends on obtaining and maintaining patent protection for its PREDATOR platform and product candidates, but the scope and validity of such protection are uncertain[275](index=275&type=chunk)[276](index=276&type=chunk) - The company may face third-party claims of intellectual property infringement, which could be expensive and time-consuming to defend and could prevent or delay development efforts[309](index=309&type=chunk) - The company relies on trade secret protection for key aspects of its technology, but it cannot guarantee that these secrets will not be disclosed or independently discovered by competitors[305](index=305&type=chunk) [Risks Related to Regulatory Approval and Legal Compliance](index=65&type=section&id=Risks%20Related%20to%20Regulatory%20Approval%20and%20Marketing%20of%20Our%20Product%20Candidates%20and%20Other%20Legal%20Compliance%20Matters) Regulatory approval is expensive and uncertain, with ongoing compliance burdens, healthcare fraud laws, data privacy regulations, and potential FDA disruptions posing risks - The regulatory approval process is expensive, time-consuming, and uncertain, and the company has no experience in filing for marketing approvals[338](index=338&type=chunk) - Disruptions at the FDA and other government agencies due to funding cuts, personnel losses, or other factors could hinder the timely approval of product candidates[347](index=347&type=chunk) - The company is subject to healthcare fraud and abuse laws, which could expose it to criminal sanctions, civil penalties, and exclusion from government healthcare programs if found non-compliant[415](index=415&type=chunk) - The company must comply with complex and evolving state, national, and international privacy and data security laws, with non-compliance potentially leading to significant fines and reputational damage[425](index=425&type=chunk) [Risks Related to Business Operations and Public Company Status](index=83&type=section&id=Risks%20Related%20to%20Our%20Business%20Operations,%20Employee%20Matters%20and%20Managing%20Growth) Risks include dependence on key personnel, cybersecurity threats, stock price volatility, and increased public company compliance costs - The company is highly dependent on retaining key employees and faces fierce competition for qualified personnel in the Boston area[450](index=450&type=chunk)[451](index=451&type=chunk) - The company is exposed to risks from cyberattacks, which could lead to data loss, operational disruption, and financial loss[453](index=453&type=chunk)[454](index=454&type=chunk) - The company's stock price is volatile, and it may be delisted from Nasdaq if it fails to meet continued listing requirements, such as the minimum bid price[465](index=465&type=chunk)[467](index=467&type=chunk) - In the past, the company has identified material weaknesses in its internal control over financial reporting, which have since been fully remediated[480](index=480&type=chunk) [Item 6. Exhibits](index=91&type=section&id=Item%206.%20Exhibits) Lists exhibits filed with the Form 10-Q, including corporate governance documents and officer certifications - This section lists the exhibits filed with the report, including corporate governance documents, an employment agreement, and officer certifications required by the Sarbanes-Oxley Act[493](index=493&type=chunk)

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