markdown [PART I. FINANCIAL INFORMATION](index=7&type=section&id=PART%20I.%20FINANCIAL%20INFORMATION) This part covers financial statements, management's analysis, market risk, and internal controls [Item 1. Condensed Financial Statements.](index=7&type=section&id=Item%201.%20Condensed%20Financial%20Statements.) This section presents the unaudited condensed consolidated financial statements, including the balance sheets, statements of operations, stockholders' equity, and cash flows, along with detailed notes explaining significant accounting policies, liquidity, recent acquisitions, and other financial disclosures for the periods ended June 30, 2025, and December 31, 2024 [Condensed Consolidated Balance Sheets](index=7&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) This section presents the company's financial position, detailing assets, liabilities, and equity | Metric | June 30, 2025 (Unaudited) | December 31, 2024 | | :-------------------------------- | :------------------------ | :------------------ | | Cash and cash equivalents | $8,512,824 | $12,657,178 | | Deposits, planned business acquisition | - | $5,994,503 | | Stock subscription receivable | $2,997,547 | - | | Total Current Assets | $12,539,459 | $19,610,389 | | Goodwill | $13,554,163 | - | | In-process research and development | $8,261,000 | - | | Total Assets | $34,621,304 | $19,966,684 | | Accounts payable and accrued expenses | $12,093,163 | $5,170,166 | | Total Current Liabilities | $15,171,776 | $5,330,010 | | Total Liabilities | $15,171,776 | $5,372,708 | | Total Stockholders' Equity | $19,449,528 | $14,593,976 | | Accumulated deficit | $(127,316,953) | $(111,124,569) | - **Total assets** increased significantly from **$19.97 million** at December 31, 2024, to **$34.62 million** at June 30, 2025, primarily due to the recognition of **goodwill** and **in-process research and development assets** from the **Kineta merger**[15](index=15&type=chunk) - **Cash and cash equivalents** decreased by approximately **$4.14 million** from December 31, 2024, to June 30, 2025[15](index=15&type=chunk) [Condensed Consolidated Statements of Operations](index=8&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) This section details the company's financial performance, including revenues, expenses, and net loss | 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 | $4,926,936 | $2,823,064 | $9,508,608 | $6,412,077 | | General and administrative expenses | $4,949,020 | $795,660 | $7,384,371 | $1,812,401 | | Operating Loss | $(9,875,956) | $(3,618,724) | $(16,892,979) | $(8,224,478) | | Grant income | $322,655 | - | $575,209 | - | | Interest expense | - | $(1,357,458) | - | $(1,612,580) | | Net Loss | $(9,523,835) | $(5,265,235) | $(16,188,206) | $(10,107,377) | | Net Loss per share, basic and diluted | $(0.21) | $(0.43) | $(0.36) | $(0.83) | | Weighted-average shares outstanding | 44,555,095 | 12,178,522 | 44,983,198 | 12,176,127 | - **Net loss** for the three months ended June 30, 2025, increased to **$9.52 million** from **$5.27 million** in the prior year, primarily driven by higher **R&D** and **G&A expenses**, partially offset by grant income and reduced interest expense[17](index=17&type=chunk) - **Weighted-average shares outstanding** significantly increased from **12.18 million** to **44.55 million** for the three months ended June 30, 2025, impacting the **net loss per share**[17](index=17&type=chunk) [Condensed Consolidated Statements of Stockholders' Equity](index=9&type=section&id=Condensed%20Consolidated%20Statements%20of%20Stockholders'%20Equity) This section outlines changes in equity, including common stock, paid-in capital, and accumulated deficit | Metric | January 1, 2025 | June 30, 2025 | | :----------------------------------- | :-------------- | :------------ | | Preferred Stock Dollars | $278,530 | $278,530 | | Common Stock Dollars | $42,324 | $49,913 | | Additional Paid in Capital | $125,397,691 | $146,438,038 | | Accumulated Deficit | $(111,124,569) | $(127,316,953) | | Total Stockholders' Equity (Deficit) | $14,593,976 | $19,449,528 | | Common Shares Outstanding | 42,323,759 | 49,913,946 | - **Total stockholders' equity** increased from **$14.59 million** at January 1, 2025, to **$19.45 million** at June 30, 2025, primarily due to increases in **additional paid-in capital** from common stock issuances and warrant exercises, despite an increased **accumulated deficit**[20](index=20&type=chunk) - The number of **common shares outstanding** increased from **42.32 million** at January 1, 2025, to **49.91 million** at June 30, 2025, reflecting issuances related to warrant exercises, the **Kineta merger**, and other capital raises[20](index=20&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=10&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) This section summarizes cash flows from operating, investing, and financing activities | Cash Flow Activity | Six months ended June 30, 2025 | Six months ended June 30, 2024 | | :--------------------------------- | :----------------------------- | :----------------------------- | | Net cash flows from Operating activities | $(10,986,584) | $(8,900,053) | | Net cash flows from Investing activities | $(1,307,511) | $(36,498) | | Net cash flows from Financing activities | $8,149,741 | $17,582,805 | | Net change in cash and cash equivalents | $(4,144,354) | $8,646,254 | | Cash and cash equivalents at end of period | $8,512,824 | $12,311,286 | - **Net cash used in operating activities** increased to **$(10.99 million)** for the six months ended June 30, 2025, from **$(8.90 million)** in the prior year, primarily due to higher **net losses**[22](index=22&type=chunk) - **Investing activities** used significantly more cash, **$1.31 million**, in the first half of 2025 compared to **$0.04 million** in 2024, largely due to the **Kineta acquisition**[22](index=22&type=chunk) [Notes to Unaudited Condensed Consolidated Financial Statements](index=11&type=section&id=Notes%20to%20Unaudited%20Condensed%20Consolidated%20Financial%20Statements) This section provides detailed explanations and disclosures for the unaudited financial statements [Note 1—Description of business and basis of presentation](index=11&type=section&id=Note%201%E2%80%94Description%20of%20business%20and%20basis%20of%20presentation) This note describes the company's business and the basis for financial statement presentation - **TuHURA Biosciences, Inc.** is a clinical-stage immuno-oncology company developing novel therapeutics to overcome cancer immunotherapy resistance, utilizing three distinct technologies: **Immune FxTM (IFx)**, **TBS-2025** (**VISTA-inhibiting antibody**), and Delta Opioid Receptor technology[24](index=24&type=chunk)[25](index=25&type=chunk)[27](index=27&type=chunk) - In June 2025, the company initiated a **Phase 3 registration trial** for its lead product candidate, **IFx-2.0**, as an adjunctive therapy to **Keytruda®** for advanced or metastatic Merkel cell carcinoma[25](index=25&type=chunk)[30](index=30&type=chunk) - The company acquired rights to **TBS-2025**, a novel **VISTA-inhibiting monoclonal antibody**, through the **Kineta acquisition** on June 30, 2025, and plans to investigate it in a Phase 2 trial for **mutated NPM1 AML**[26](index=26&type=chunk)[33](index=33&type=chunk) - A **private placement** in June 2025 raised approximately **$12.6 million** through the issuance of **common stock** and **warrants**, with **$8.9 million** purchased by June 30, 2025, and the remaining **$3.7 million** due by December 31, 2025[29](index=29&type=chunk)[31](index=31&type=chunk) [Note 2—Summary of significant accounting policies](index=13&type=section&id=Note%202%E2%80%94Summary%20of%20significant%20accounting%20policies) This note outlines key accounting principles and methods used in financial statements - The condensed consolidated financial statements are prepared in accordance with **U.S. GAAP** and include wholly-owned subsidiaries, with all intercompany balances eliminated[36](index=36&type=chunk)[37](index=37&type=chunk) - The company expenses **research and development costs** as incurred and accounts for **stock-based awards** using the fair value-based method with the **Black-Scholes valuation model**[40](index=40&type=chunk)[42](index=42&type=chunk) - Acquired businesses are accounted for using the **acquisition method**, with acquired **in-process research and development (IPR&D)** capitalized as an **indefinite-lived intangible asset** not subject to amortization until completion or abandonment[43](index=43&type=chunk)[45](index=45&type=chunk) - The company operates in one **reportable segment** focused on cancer treatment, consistent with how its chief operating decision maker reviews performance[46](index=46&type=chunk)[47](index=47&type=chunk) [Note 3—Liquidity and management's plans](index=17&type=section&id=Note%203%E2%80%94Liquidity%20and%20management's%20plans) This note discusses the company's liquidity and management's plans for future funding - The company has historically incurred negative **cash flows from operations**, with **$11.0 million** used in the six months ended June 30, 2025[52](index=52&type=chunk)[53](index=53&type=chunk) - As of June 30, 2025, **cash and cash equivalents** totaled **$8.5 million**, which is expected to fund operations into the late fourth quarter of 2025[53](index=53&type=chunk) - There is substantial doubt about the company's ability to continue as a **going concern** for the next 12 months, necessitating additional fundraising through equity, debt, grants, or commercial partnerships[55](index=55&type=chunk) [Note 4—Acquisition](index=18&type=section&id=Note%204%E2%80%94Acquisition) This note details the financial impact and accounting treatment of the recent acquisition - On June 30, 2025, **TuHURA** acquired **100% of Kineta**, a clinical-biotechnology company, for its **VISTA blocking immunotherapy** (renamed **TBS-2025**) and related assets[56](index=56&type=chunk) | Purchase Consideration | Amount | | :------------------------------------------ | :------------- | | Exclusivity cash deposit | $5,994,502 | | Equity issued to Kineta shareholders | $6,396,017 | | Holdback liability to be issued in equity | $2,519,644 | | Cash previously advanced | $1,650,000 | | **Fair value of consideration** | **$16,560,163** | | Assets Acquired: | | | Cash | $390,721 | | Acquired in-process research and development | $8,261,000 | | **Total assets acquired** | **$8,651,721** | | Liabilities Assumed: | | | Accrued expenses, assumed debt, severance | $(5,645,721) | | **Total liabilities assumed** | **$(5,645,721)** | | Net assets acquired | $3,006,000 | | **Goodwill** | **$13,554,163** | - The **acquisition** resulted in the recognition of **$13.55 million** in **goodwill** and **$8.26 million** in **in-process research and development (IPR&D)** intangible assets[59](index=59&type=chunk) - The company incurred approximately **$3.9 million** in initial transaction costs for the **Kineta merger**, recorded under **general and administrative expenses**[63](index=63&type=chunk) [Note 5—Net loss per share](index=20&type=section&id=Note%205%E2%80%94Net%20loss%20per%20share) This note explains the calculation of basic and diluted net loss per share | 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 loss attributable to common stockholders | $(9,525,924) | $(5,265,235) | $(16,192,384) | $(10,107,377) | | Weighted-average common shares outstanding | 44,555,095 | 12,178,522 | 44,983,198 | 12,176,127 | | Net loss per share, basic and diluted | $(0.21) | $(0.43) | $(0.36) | $(0.83) | - Basic and diluted **net loss per share** for the three months ended June 30, 2025, was **$(0.21)**, an improvement from **$(0.43)** in the prior year, despite a higher **net loss**, due to a significant increase in **weighted-average shares outstanding**[66](index=66&type=chunk) - Potential dilutive securities, including preferred stock, convertible notes, **stock options**, and **warrants**, were excluded from diluted EPS calculations as their effect would be anti-dilutive due to **net losses**[67](index=67&type=chunk)[68](index=68&type=chunk) [Note 6—Other current assets](index=21&type=section&id=Note%206%E2%80%94Other%20current%20assets) This note provides a breakdown of the company's other current assets | Other Current Assets | June 30, 2025 | December 31, 2024 | | :------------------------- | :------------ | :---------------- | | Employee Retention Tax Credit | $214,699 | $214,699 | | NIH Grant Receivable | $194,670 | $222,702 | | Clinical trial deposit | $204,955 | $204,955 | | Other current assets | $414,764 | $316,352 | | **Total** | **$1,029,088** | **$958,708** | - **Total other current assets** increased slightly to **$1.03 million** at June 30, 2025, from **$0.96 million** at December 31, 2024, primarily driven by an increase in 'Other current assets'[69](index=69&type=chunk) [Note 7—Property and equipment, net](index=21&type=section&id=Note%207%E2%80%94Property%20and%20equipment,%20net) This note details the company's property and equipment, net of depreciation | Property and Equipment | June 30, 2025 | December 31, 2024 | | :--------------------------- | :------------ | :---------------- | | Furniture and fixtures | $170,607 | $170,607 | | Leasehold improvements | $544,629 | $544,629 | | Machinery and office equipment | $1,471,417 | $1,423,183 | | Software | $72,394 | $72,394 | | Less accumulated depreciation | $(2,114,876) | $(2,087,447) | | **Net Property and equipment** | **$144,171** | **$123,366** | - **Net property and equipment** increased to **$0.14 million** at June 30, 2025, from **$0.12 million** at December 31, 2024, mainly due to additions in machinery and office equipment[70](index=70&type=chunk) - Depreciation and amortization expense for **property and equipment** was approximately **$0.03 million** for the six months ended June 30, 2025, compared to **$0.07 million** for the same period in 2024[70](index=70&type=chunk) [Note 8—Accounts payable, debt, and accrued expenses](index=21&type=section&id=Note%208%E2%80%94Accounts%20payable,%20debt,%20and%20accrued%20expenses) This note provides a breakdown of accounts payable, debt, and accrued expenses | Accounts Payable and Accrued Expenses | June 30, 2025 | December 31, 2024 | | :------------------------------------------ | :------------ | :---------------- | | Trade accounts payable | $3,646,806 | $3,152,816 | | Accrued compensation | $809,237 | $1,161,650 | | Assumed liabilities from Kineta merger | $5,211,727 | - | | Other accrued expenses | $2,425,393 | $855,700 | | **Total** | **$12,093,163** | **$5,170,166** | - **Total accounts payable and accrued expenses** significantly increased to **$12.09 million** at June 30, 2025, from **$5.17 million** at December 31, 2024, primarily due to **$5.21 million** in **liabilities assumed** from the **Kineta merger**[71](index=71&type=chunk) - The company assumed debt with a fair value of **$0.43 million** from the **Kineta merger**, which was settled and paid in July 2025[71](index=71&type=chunk) [Note 9—Income taxes](index=23&type=section&id=Note%209%E2%80%94Income%20taxes) This note discusses the company's income tax position and valuation allowances - The company has provided a full **valuation allowance** for **deferred tax assets** as of June 30, 2025, and December 31, 2024, due to its history of **operating losses**, indicating that the benefit of these assets is not likely to be realized[73](index=73&type=chunk) [Note 10—Stockholders' equity](index=23&type=section&id=Note%2010%E2%80%94Stockholders'%20equity) This note details changes in stockholders' equity, including stock and warrants - As of June 30, 2025, the company had **49.91 million shares** of **common stock outstanding**, authorized up to **200 million shares**[75](index=75&type=chunk) - The June 2025 **Private Placement** involved the issuance of **4.76 million common shares** and an equal number of **warrants** for approximately **$12.6 million**, with **$8.9 million** received by June 30, 2025, and the remaining **$3.7 million** due by December 31, 2025[77](index=77&type=chunk) | Warrant Type | Outstanding at June 30, 2025 | Weighted Average Exercise Price | Expiration Dates | | :------------------------------------------ | :--------------------------- | :------------------------------ | :----------------------------- | | Legacy TuHURA common stock warrants | 8,324,808 | $4.52 | Oct 2025 to Aug 2029 | | Historical Kintara common stock warrants | 10,199 | $757.65 | June 2025 to April 2027 | | TuHURA Warrants from 2025 Securities Purchase Agreement | 3,363,076 | $3.32 | December 2030 | | TuHURA Warrants issued to placement agent | 134,523 | $3.32 | December 2030 | | 2024 common stock warrants issued to financial advisor | 297,029 | $0.01 | April 2027 | | **Total** | **12,129,635** | | | [Note 11—Stock option plans](index=25&type=section&id=Note%2011%E2%80%94Stock%20option%20plans) This note outlines the company's stock option plans and related compensation | Stock Option Activity | Number of Options | Weighted Average Exercise Price | | :-------------------------- | :---------------- | :------------------------------ | | Outstanding at Dec 31, 2024 | 6,403,818 | $5.11 | | Forfeited and cancelled | (131,193) | $3.69 | | Exercised | (271,853) | $2.09 | | Granted | 505,298 | $3.39 | | **Outstanding at June 30, 2025** | **6,506,070** | **$5.13** | | Exercisable at June 30, 2025 | 2,312,493 | $5.99 | - Total **stock-based compensation expense** for the six months ended June 30, 2025, was **$2.83 million**, significantly higher than **$0.61 million** in the prior year, allocated to **general and administrative** (**$0.99 million**) and **research and development** (**$1.84 million**)[84](index=84&type=chunk) - As of June 30, 2025, approximately **$14.0 million** of unrecognized **stock compensation expense** remains, to be recognized over the next three years[83](index=83&type=chunk) [Note 12—Commitments and contingencies](index=26&type=section&id=Note%2012%E2%80%94Commitments%20and%20contingencies) This note discloses contractual commitments and potential contingent liabilities | Lease Commitments | Amount | | :-------------------------------- | :------- | | Year ending December 31, 2025 (6 months) | $86,823 | | Year ending December 31, 2026 | $43,411 | | Interest portion of right of use liability | $(5,265) | | **Operating lease liabilities** | **$124,969** | | Employment Agreement Commitments | Amount | | :----------------------------------- | :--------- | | Year ending December 31, 2025 (6 months) | $437,000 | | Year ending December 31, 2026 | $874,000 | | **Total** | **$1,311,000** | [Note 13—Subsequent events](index=26&type=section&id=Note%2013%E2%80%94Subsequent%20events) This note reports significant events occurring after the reporting period - Subsequent to the **Kineta Merger**, the company entered into consulting agreements with six former Kineta employees, involving cash payments and **stock awards** (approximately **0.13 million shares** at **$2.50** per share) and notes payable totaling **$0.59 million**[90](index=90&type=chunk) - The company filed a registration statement on **Form S-1** on August 12, 2025, for the resale of **common stock** and shares underlying **warrants** issued in the June 2025 **Private Placement**[91](index=91&type=chunk)[92](index=92&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=29&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) This section provides an overview of the company's financial condition, results of operations, and liquidity, highlighting recent developments such as the Kineta merger and private placement [Overview](index=29&type=section&id=Overview) This section covers the company's business, financial performance, and future outlook - **TuHURA Biosciences** is a clinical-stage immuno-oncology company focused on developing novel therapeutics to overcome resistance to cancer immunotherapies, leveraging its **Immune FxTM**, **TBS-2025**, and Delta Opioid Receptor technologies[95](index=95&type=chunk)[96](index=96&type=chunk)[97](index=97&type=chunk)[98](index=98&type=chunk) - The company has incurred significant **operating losses** since inception, with **net losses** of **$16.2 million** and **$10.1 million** for the six months ended June 30, 2025 and 2024, respectively, and an **accumulated deficit** of **$127.3 million** as of June 30, 2025[100](index=100&type=chunk) - The company expects **operating losses** to increase substantially as it advances product candidates through preclinical and clinical development and incurs costs associated with operating as a public company, requiring substantial additional funding[100](index=100&type=chunk)[101](index=101&type=chunk)[102](index=102&type=chunk) [Recent Developments](index=31&type=section&id=Recent%20Developments) This section highlights key recent events impacting the company's financial and operational status - In June 2025, the company completed a **private placement** offering of **common stock** and **warrants**, raising approximately **$12.6 million**, with **$8.9 million** received by June 30, 2025, tied to key milestones including **FDA clearance** and **Phase 3 trial initiation**[105](index=105&type=chunk)[106](index=106&type=chunk)[107](index=107&type=chunk) - The **Kineta Merger** closed on June 30, 2025, resulting in Kineta stockholders receiving approximately **2.87 million shares** of **TuHURA common stock**, plus deferred shares and potential cash consideration[111](index=111&type=chunk)[112](index=112&type=chunk) [Components of Our Results of Operations](index=33&type=section&id=Components%20of%20Our%20Results%20of%20Operations) This section details the primary revenue and expense categories contributing to the company's financial results - The company has not generated any revenue from product sales and does not expect to in the near future[113](index=113&type=chunk) - **Research and development expenses**, recognized as incurred, primarily relate to the development of **IFx-2.0**, **IFx-3.0**, manufacturing, clinical studies, and preclinical activities, and are expected to increase substantially[114](index=114&type=chunk)[115](index=115&type=chunk)[117](index=117&type=chunk) - **General and administrative expenses**, consisting of salaries, legal, accounting, and facility costs, are also anticipated to increase to support **R&D**, potential commercialization, and public company compliance[119](index=119&type=chunk) - Other income (expense) includes interest income, interest expense on convertible notes (now converted), grant income, and non-cash changes in the fair value of derivative liabilities[120](index=120&type=chunk) [Results of Operations](index=36&type=section&id=Results%20of%20Operations) This section analyzes the company's financial performance over the reported periods [Comparisons for the Three Months Ended June 30, 2025, and June 30, 2024](index=36&type=section&id=Comparisons%20for%20the%20Three%20Months%20Ended%20June%2030,%202025,%20and%20June%2030,%202024) This section compares the company's financial performance for the three-month periods ended June 30, 2025, and 2024 | Metric | June 30, 2025 | June 30, 2024 | Change | | :-------------------------------- | :------------ | :------------ | :----------- | | Research and development | $4,926,936 | $2,823,064 | $2,103,872 | | General and administrative | $4,949,020 | $795,660 | $4,153,360 | | Total operating expenses | $9,875,956 | $3,618,724 | $6,257,232 | | Loss from operations | $(9,875,956) | $(3,618,724) | $(6,257,232) | | Grant income | $322,655 | - | $322,655 | | Interest expense | - | $(1,357,458) | $1,357,458 | | Net loss | $(9,523,835) | $(5,265,235) | $(4,258,600) | - **Research and development expenses** increased by **$2.10 million**, driven by ongoing clinical development of **IFx-2.0**, preclinical research for **IFx-3.0** and MDSCs, and higher personnel costs[123](index=123&type=chunk)[126](index=126&type=chunk) - **General and administrative expenses** surged by **$4.15 million**, primarily due to increased non-cash **stock compensation**, **Kineta acquisition merger transaction costs**, and public company **operating expenses**[124](index=124&type=chunk) [Comparisons for the Six Months Ended June 30, 2025, and June 30, 2024](index=38&type=section&id=Comparisons%20for%20the%20Six%20Months%20Ended%20June%2030,%202025,%20and%20June%2030,%202024) This section compares the company's financial performance for the six-month periods ended June 30, 2025, and 2024 | Metric | June 30, 2025 | June 30, 2024 | Change | | :-------------------------------- | :------------ | :------------ | :----------- | | Research and development | $9,508,608 | $6,412,077 | $3,096,531 | | General and administrative | $7,384,371 | $1,812,401 | $5,571,970 | | Total operating expenses | $16,892,979 | $8,224,478 | $8,668,501 | | Loss from operations | $(16,892,979) | $(8,224,478) | $(8,668,501) | | Grant income | $575,209 | - | $575,209 | | Interest expense | - | $(1,612,580) | $1,612,580 | | Net loss | $(16,188,206) | $(10,107,377) | $(6,080,829) | - For the six months, **R&D expenses** increased by **$3.10 million**, primarily due to **IFx-2.0** clinical development, preclinical research for **IFx-3.0** and MDSCs, and a **$2.20 million** increase in personnel and facilities-related costs[131](index=131&type=chunk) - **General and administrative expenses** rose by **$5.57 million**, mainly attributable to higher non-cash **stock compensation**, **Kineta acquisition transaction costs**, and expenses associated with being a public company[132](index=132&type=chunk) [Liquidity and Capital Resources](index=40&type=section&id=Liquidity%20and%20Capital%20Resources) This section assesses the company's ability to meet its financial obligations and fund future operations - The company has an **accumulated deficit** of **$127.3 million** as of June 30, 2025, and has consistently incurred **net losses** and negative **cash flows from operations**[137](index=137&type=chunk) - **Net cash used in operating activities** was **$(10.99 million)** for the six months ended June 30, 2025, compared to **$(8.90 million)** for the same period in 2024[137](index=137&type=chunk) - As of June 30, 2025, **cash and cash equivalents** totaled **$8.51 million**, with an additional **$3.00 million** in gross proceeds received in July 2025 from the **Securities Purchase Agreement**, expected to fund operations through late Q4 2025[138](index=138&type=chunk)[150](index=150&type=chunk) - Future funding requirements are substantial and will depend on the progress of product candidates, regulatory approvals, and commercialization efforts, necessitating additional capital through equity, debt, or collaborations[151](index=151&type=chunk)[152](index=152&type=chunk) [Critical Accounting Policies and Significant Judgments and Estimates](index=44&type=section&id=Critical%20Accounting%20Policies%20and%20Significant%20Judgments%20and%20Estimates) This section outlines the accounting policies requiring significant management judgment and estimation - Key **accounting policies** requiring significant estimates and judgments include accrued **research and development expenses**, **stock-based compensation expense** (using the **Black-Scholes model**), common stock valuations, and the valuation of **intangible assets** from the **Kineta acquisition**[153](index=153&type=chunk)[154](index=154&type=chunk)[158](index=158&type=chunk)[159](index=159&type=chunk)[162](index=162&type=chunk)[164](index=164&type=chunk) - The valuation of acquired **in-process research and development (IPR&D)** involves significant measurement uncertainty due to a lack of historical data, relying on life science studies, industry data, and peer company information[167](index=167&type=chunk) [Recently Issued and Adopted Accounting Pronouncements](index=47&type=section&id=Recently%20Issued%20and%20Adopted%20Accounting%20Pronouncements) This section discusses new accounting standards and their impact on the company's financial statements - The company adopted ASU 2023-07, **Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures**, which did not have a material impact on its condensed consolidated financial statements[46](index=46&type=chunk)[169](index=169&type=chunk) [Off-Balance Sheet Arrangements](index=47&type=section&id=Off-Balance%20Sheet%20Arrangements) This section discloses any off-balance sheet arrangements that could materially affect the company's financial condition - The company does not have any **off-balance sheet arrangements** as defined under SEC rules[170](index=170&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=48&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) This section discusses the company's exposure to market risks, primarily interest rate risks and inflation risks, and management's assessment of their impact - The company is exposed to **interest rate risk** through its cash and short-term money market investments, though historical fluctuations in interest income have not been significant[171](index=171&type=chunk)[172](index=172&type=chunk) - **Inflation risk** primarily affects the company's labor and **research and development contract costs**, but management believes it has not had a material effect on results of operations during the periods presented[173](index=173&type=chunk) [Item 4. Controls and Procedures](index=48&type=section&id=Item%204.%20Controls%20and%20Procedures) This section details the effectiveness of the company's disclosure controls and procedures and internal control over financial reporting, as evaluated by management - Management, with the participation of the CEO and CFO, concluded that the company's **disclosure controls and procedures** were effective at the reasonable assurance level as of June 30, 2025[175](index=175&type=chunk) - Management also concluded that the company's **internal control over financial reporting** was effective as of June 30, 2025, based on the **COSO framework**[176](index=176&type=chunk) - There were no material changes in **internal control over financial reporting** during the most recently completed fiscal quarter[178](index=178&type=chunk) [PART II. OTHER INFORMATION](index=49&type=section&id=PART%20II.%20OTHER%20INFORMATION) This part includes legal proceedings, risk factors, equity sales, and other corporate information [Item 1. Legal Proceedings.](index=49&type=section&id=Item%201.%20Legal%20Proceedings.) This section confirms the absence of any material legal proceedings or claims against the company - As of the date of this quarterly report, the company is not a party to any material legal matters or claims[180](index=180&type=chunk) [Item 1A. Risk Factors.](index=49&type=section&id=Item%201A.%20Risk%20Factors.) This section updates the risk factors, noting no material changes from the Annual Report on Form 10-K, except for new risks specifically related to the Kineta Merger - No material changes to **risk factors** were identified from the Annual Report on **Form 10-K**, except for those related to the **Kineta Merger**[181](index=181&type=chunk)[182](index=182&type=chunk) - **Risks related to the Kineta Merger** include potential declines in the market price of **common stock** due to sales by former Kineta stockholders and significant non-recurring and integration costs associated with combining operations[183](index=183&type=chunk)[184](index=184&type=chunk)[185](index=185&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=49&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) This section discloses the details of unregistered sales of equity securities, specifically the June 2025 private placement - On June 2, 2025, the company entered into a **securities purchase agreement** for a **private placement** of **4.76 million shares** of **common stock** and equal number of **warrants**, for an aggregate offering amount of approximately **$12.6 million**, under Section 4(a)(2) and/or Rule 506(b) of the **Securities Act**[186](index=186&type=chunk) [Item 3. Defaults Upon Senior Securities.](index=49&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities.) This section confirms that there have been no defaults upon senior securities - There were no defaults upon senior securities[187](index=187&type=chunk) [Item 4. Mine Safety Disclosures.](index=51&type=section&id=Item%204.%20Mine%20Safety%20Disclosures.) This section states that mine safety disclosures are not applicable to the company - Mine safety disclosures are not applicable to the company[188](index=188&type=chunk) [Item 5. Other Information.](index=51&type=section&id=Item%205.%20Other%20Information.) This section provides other information, including details on director and officer trading arrangements - None of the company's directors or officers adopted or terminated a **Rule 10b5-1 trading plan** or arrangement, or a non-Rule 10b5-1 trading plan or arrangement, during the six months ended June 30, 2025[191](index=191&type=chunk) [Item 6. Exhibits.](index=52&type=section&id=Item%206.%20Exhibits.) This section lists all exhibits filed as part of the Form 10-Q, including merger agreements, articles of incorporation, bylaws, warrant forms, and certifications - The exhibits include the **Agreement and Plan of Merger** for the **Kineta acquisition**, Articles of Incorporation, Amended and Restated Bylaws, various forms of **common stock purchase warrants**, and certifications of principal executive and financial officers[193](index=193&type=chunk)[194](index=194&type=chunk) [Signatures](index=55&type=section&id=Signatures) This section contains the signatures of authorized officers, certifying the report - The report is duly signed on August 14, 2025, by James A. Bianco, M.D., President and Chief Executive Officer, and Dan Dearborn, Chief Financial Officer[201](index=201&type=chunk)
TuHURA Biosciences, Inc.(HURA) - 2025 Q4 - Annual Report