Virios Therapeutics(VIRI) - 2025 Q2 - Quarterly Report

PART I — FINANCIAL INFORMATION This section presents the unaudited condensed consolidated financial statements and related notes for Dogwood Therapeutics, Inc Item 1. Financial Statements This section presents unaudited condensed consolidated financial statements and notes, covering balance sheets, operations, equity, and cash flows Condensed Consolidated Balance Sheets This section provides a snapshot of the company's financial position at specific dates, detailing assets, liabilities, and equity Total Assets | Date | Amount ($) | | :--- | :--- | | June 30, 2025 | 96,692,527 | | December 31, 2024 | 94,308,246 | Total Liabilities | Date | Amount ($) | | :--- | :--- | | June 30, 2025 | 14,151,904 | | December 31, 2024 | 30,027,223 | Total Stockholders' Equity (Deficit) | Date | Amount ($) | | :--- | :--- | | June 30, 2025 | 6,878,599 | | December 31, 2024 | (10,124,339) | Cash and Cash Equivalents | Date | Amount ($) | | :--- | :--- | | June 30, 2025 | 13,402,809 | | December 31, 2024 | 14,847,949 | Goodwill | Date | Amount ($) | | :--- | :--- | | June 30, 2025 | 12,458,383 | | December 31, 2024 | 11,812,476 | In-process research and development assets | Date | Amount ($) | | :--- | :--- | | June 30, 2025 | 69,303,582 | | December 31, 2024 | 65,710,527 | Condensed Consolidated Statements of Operations and Comprehensive Loss This section details the company's financial performance over specific periods, including net loss, expenses, and earnings per share Net Loss | Period | June 30, 2025 (3 months) | June 30, 2024 (3 months) | June 30, 2025 (6 months) | June 30, 2024 (6 months) | | :--- | :--- | :--- | :--- | :--- | | Net Loss ($) | (3,807,353) | (1,049,833) | (14,732,305) | (2,341,168) | Research and Development Expenses | Period | June 30, 2025 (3 months) | June 30, 2024 (3 months) | June 30, 2025 (6 months) | June 30, 2024 (6 months) | | :--- | :--- | :--- | :--- | :--- | | R&D Expenses ($) | 2,569,943 | 336,084 | 5,006,941 | 679,801 | General and Administrative Expenses | Period | June 30, 2025 (3 months) | June 30, 2024 (3 months) | June 30, 2025 (6 months) | June 30, 2024 (6 months) | | :--- | :--- | :--- | :--- | :--- | | G&A Expenses ($) | 1,353,172 | 733,740 | 3,346,100 | 1,704,124 | Earnings Per Share (EPS) | Period | June 30, 2025 (3 months) | June 30, 2024 (3 months) | June 30, 2025 (6 months) | June 30, 2024 (6 months) | | :--- | :--- | :--- | :--- | :--- | | EPS ($) | (1.99) | (1.15) | (9.51) | (2.78) | - Loss on debt conversion with related party for the six months ended June 30, 2025: $6,134,120[12] Condensed Consolidated Statements of Changes in Series A Non-Voting Convertible Preferred Stock and Stockholders' Equity (Deficit) This section outlines changes in preferred stock and stockholders' equity, reflecting financing activities and accumulated deficit - Total Stockholders' Equity (Deficit) at June 30, 2025: $6,878,599[14] - Total Stockholders' Equity (Deficit) at December 31, 2024: $(10,124,339)[14] - Conversion of loan payable plus interest into Series A-1 Non-Voting Convertible Preferred Stock: $24,994,461[14] - Proceeds from registered direct offering of common stock, net of offering costs: $4,252,793[14] - Accrual of paid-in-kind dividends on Series A Non-Voting Convertible Preferred Stock: $(1,256,662)[14] Condensed Consolidated Statements of Cash Flows This section reports cash inflows and outflows from operating, investing, and financing activities over specific periods Summary of Cash Flows | Period | June 30, 2025 (6 months) | June 30, 2024 (6 months) | | :--- | :--- | :--- | | Net Cash Used in Operating Activities ($) | (8,708,672) | (1,749,160) | | Net Cash Provided by Financing Activities ($) | 7,252,245 | 1,452,397 | | Net Decrease in Cash ($) | (1,456,427) | (296,763) | Cash, End of Period | Period | June 30, 2025 | June 30, 2024 | | :--- | :--- | :--- | | Cash, End of Period ($) | 13,402,809 | 3,020,183 | - Non-cash financing activity: Conversion of debt with related party into Series A-1 Non-Voting Convertible Preferred Stock: $19,500,000[15] - Non-cash financing activity: Accrual of paid-in-kind dividends on Series A Non-Voting Convertible Preferred Stock: $1,256,662[15] Notes to Condensed Consolidated Financial Statements This section provides detailed explanations and disclosures supporting the condensed consolidated financial statements 1 Organization and Nature of Business This note describes the company's corporate identity, business focus, development pipeline, and going concern considerations - Company changed name from Virios Therapeutics, Inc. to Dogwood Therapeutics, Inc. on October 9, 2024, following the acquisition of Pharmagesic (Holdings) Inc. on October 7, 2024[17] - The Company is a pre-revenue, development-stage biopharmaceutical company focused on developing new medicines for pain and fatigue-related disorders[18] - Research pipeline focuses on Nav 1.7 modulation for chronic/acute pain (lead candidate: Halneuron®) and combination antiviral therapies for reactivated herpes virus mediated illnesses (IMC-1, IMC-2)[18] - Halneuron® Phase 2b CINP study ("HALT-CINP-203") commenced in Q1 2025[18] - The Company has incurred significant losses and negative cash flows from operating activities since inception, with an accumulated deficit of $88,551,251 as of June 30, 2025[19] - Substantial doubt exists about the Company's ability to operate as a going concern beyond Q1 2026 without additional financing[23] - On March 12, 2025, a $19.5 million loan from Conjoint Inc. (plus accrued interest) was converted into 284.2638 shares of Series A-1 Non-Voting Convertible Preferred Stock[20][21] - On March 14, 2025, the Company closed a registered direct offering, generating approximately $4.25 million in net proceeds[22] 2 Summary of Significant Accounting Policies This note outlines the key accounting principles and methods used in preparing the interim financial statements - Interim financial statements are unaudited and prepared in accordance with SEC rules for interim financial information, not including all U.S. GAAP disclosures for complete financial statements[24] - The Company operates in one reportable segment: development of clinical and preclinical product candidates for pain and fatigue illness[28] - On October 9, 2024, the Company effected a 25-for-1 reverse stock split, retroactively adjusted for all periods presented[26] - The Company is an emerging growth company and has elected to use the extended transition period for complying with new or revised accounting standards until December 31, 2025[52][153] - Recent Accounting Pronouncements: FASB issued ASU 2023-09 (Improvements to Income Tax Disclosures), ASU 2024-03 (Expense Disaggregation Disclosures), and ASU 2025-03 (Determining the Accounting Acquirer in the Acquisition of a Variable Interest Entity), all of which the Company is currently evaluating for impact[53][56][57] 3 Business Combination This note details the acquisition of Pharmagesic (Holdings) Inc. and its impact on the company's financial position - On October 7, 2024, the Company acquired 100% of Pharmagesic (Holdings) Inc. from Sealbond Limited, accounted for under the acquisition method[58][62] - Total consideration paid for the acquisition was approximately $71.3 million, consisting of common stock ($893,093) and Series A Preferred Stock ($70,372,634)[63] Acquired Assets and Assumed Liabilities | Asset/Liability | Amount ($) | | :--- | :--- | | Cash | 3,762,000 | | Prepaid expenses and other current assets | 380,000 | | Property and equipment | 19,000 | | In-process research and development assets | 69,500,000 | | Goodwill | 12,493,727 | | Right-of-use asset - operating leases | 230,000 | | Accounts payable | 904,000 | | Accrued expenses and other current liabilities | 2,017,000 | | Deferred tax liability | 11,968,000 | | Operating lease liabilities | 230,000 | | Net assets acquired | 71,265,727 | Acquired Intangible Assets and Goodwill | Asset | Combination Date Fair Value ($) | Carrying Value as of June 30, 2025 ($) | | :--- | :--- | :--- | | Halneuron® for Cancer Related Pain | 59,900,000 | 59,730,713 | | Halneuron® for Chemotherapy Induced Neuropathic Pain | 9,600,000 | 9,572,869 | | Total in-process research and development (IPR&D) | 69,500,000 | 69,303,582 | | Goodwill | 12,493,727 | 12,458,383 | 4 Prepaid Expenses and Other Current Assets This note provides a breakdown of prepaid expenses and other current assets, including clinical research costs and insurance - Prepaid expenses and other current assets decreased from $1,696,513 at December 31, 2024, to $1,301,485 at June 30, 2025[68] - Significant components at June 30, 2025, include Prepaid clinical research costs ($795,724) and Prepaid insurance ($347,811)[68] 5 Property and Equipment This note details the company's property and equipment, including changes in net book value over the period - Net property and equipment decreased slightly from $16,811 at December 31, 2024, to $16,179 at June 30, 2025[69] 6 License Agreement This note describes the company's long-term know-how license agreement with the University of Alabama - The Company has a Know-How License Agreement with the University of Alabama (UA) since 2012, which granted UA a 10% non-voting (later voting) membership interest, converted to Common Stock upon Corporate Conversion[70] - The agreement is in effect for 25 years and will terminate on June 1, 2037[70] 7 Accrued Expenses This note provides a breakdown of accrued expenses, including compensation, clinical research costs, and interest - Accrued expenses decreased from $1,894,835 at December 31, 2024, to $1,332,574 at June 30, 2025[71] - Major components at June 30, 2025, include Accrued compensation ($496,448), Accrued clinical research costs ($446,942), and Accrued interest on preferred members' interests and related party loan ($188,085)[71] 8 Leases This note details the company's operating lease arrangements, including lease terms, expenses, and future commitments - The Company acquired an operating lease for an office in Vancouver, British Columbia, as part of the Pharmagesic Combination, expiring August 31, 2028[73] - Total lease expense for the six months ended June 30, 2025, was $55,231[74] - Future minimum annual commitments under operating leases total $210,482, with a present value of $186,990[74] - Weighted-average remaining lease term is 3.2 years, with a weighted-average discount rate of 7.82%[74] 9 Promissory Note with Related Party This note describes the loan agreement with Conjoint Inc., its conversion into preferred stock, and the resulting loss - On October 7, 2024, the Company entered into a Loan Agreement with Conjoint Inc. (an affiliate of CKLS) for $19.5 million, disbursed in two tranches ($16.5M on Oct 7, 2024, $3.0M on Feb 18, 2025)[75] - The loan bore interest at SOFR + 2.00% and was due October 7, 2027[77] - On March 12, 2025, the $19,926,891 principal and accrued interest was converted into 284.2638 shares of Series A-1 Non-Voting Convertible Preferred Stock[78] - A loss on debt extinguishment of $6,134,120 was recognized due to the conversion[79] - As of December 31, 2024, the fair value of the related party note payable was approximately $15.7 million[80] 10 Stockholders' Equity This note details the company's capital structure, including preferred stock, common stock, and equity financing activities Preferred Stock This section outlines the authorization and issuance of the company's preferred stock - Board authorized to issue up to 2,000,000 shares of preferred stock[81] - As of June 30, 2025, 1,997,446 shares of preferred stock were authorized, with no shares issued and outstanding (excluding Series A and A-1)[82] Series A Preferred Stock This section details the designation, issuance, rights, conversion terms, and redemption conditions of Series A Preferred Stock - 2,270 shares designated as Series A Preferred Stock in October 2024[83] - As of June 30, 2025, 2,269.1494 shares were issued and outstanding[84] - Series A Preferred Stock generally has no voting rights but requires majority holder approval for adverse changes to its rights or certain corporate actions[85] - Each share is convertible into 10,000 shares of Common Stock upon stockholder approval of the Conversion Proposal, subject to beneficial ownership limitations[87] - Redeemable for cash at holder's option under certain conditions (e.g., futile Phase 2b study, delisting, failure to complete interim analysis by Dec 31, 2025, or June 30, 2026)[87] - Holders received a 5.0% PIK dividend, with 55.345 shares issued on April 7, 2025[88] Form of Repurchase Agreement This section describes Sealbond's option to acquire intellectual property related to tetrodotoxin and Halneuron® - Sealbond has an option to acquire all of the Company's intellectual property, rights, and interests related to tetrodotoxin and Halneuron® for a cash settlement value, upon certain conditional events[89][90] Contingent Value Rights Agreement This section explains the contingent value rights granted to common stockholders and their payment terms - Each Common Stock holder as of October 17, 2024, received one contractual contingent value right (CVR)[91] - CVR holders are entitled to 87.75% of any Upfront Payment or Milestone Payment received by the Company quarterly, subject to deductions[92][93] - CVRs are generally non-transferable and do not grant shareholder rights[94] - The fair value of CVRs was determined to be immaterial at issuance and as of June 30, 2025, due to no imminent transactions indicating value[95] Series A-1 Preferred Stock This section details the designation, issuance, ranking, voting rights, and conversion terms of Series A-1 Preferred Stock - 284.2638 shares designated as Series A-1 Preferred Stock in March 2025, all issued and outstanding as of June 30, 2025[96] - Ranks on parity with Common Stock for liquidation distributions[97] - Generally non-voting, but requires majority holder approval for adverse changes to its rights or certain corporate actions[98][100] - Convertible into 10,000 shares of Common Stock per share upon stockholder approval, subject to beneficial ownership limitations[101] Common Stock This section outlines the authorized shares and par value of the company's common stock - Authorized 43,000,000 shares of Common Stock with a par value of $0.0001 per share[102] Registered Direct Offering This section details the issuance of common stock in a registered direct offering and the resulting net proceeds - On March 12, 2025, the Company issued 578,950 shares of Common Stock at $8.26 per share in a registered direct offering[103] - Gross proceeds were approximately $4.78 million, with net proceeds of approximately $4.25 million[103] 11 Related Parties This note identifies transactions and relationships with related parties, including consulting services and loan agreements - The Company contracts Gendreau Consulting, LLC (managed by the CMO) for drug development and clinical trial activities[104] - Payments to Gendreau: $52,000 (3 months ended June 30, 2025) and $240,577 (6 months ended June 30, 2025)[104] - CMO's spouse serves as Chief Safety Officer for the HALT-CINP-203 clinical trial, and CMO's daughter assists with clinical site activities[104] - Conjoint Inc., an affiliate of CKLS, is a related party involved in the $19.5 million loan and subsequent debt conversion[104][75] 12 Commitments and Contingencies This note addresses potential claims and litigation, confirming no material pending or ongoing legal proceedings - The Company is subject to claims by third parties but currently has no pending or ongoing material litigation[105][106][160] 13 Share-based compensation This note details the company's equity incentive plan, stock options, and warrants, including related expenses Equity Incentive Plan This section outlines the company's equity incentive plan, including shares reserved, options outstanding, and compensation expense - Stockholders approved an increase of 108,612 shares to the 2020 Equity Incentive Plan, totaling 191,112 shares reserved[107] - As of June 30, 2025, 182 shares were available for future grants[107] - Options outstanding at June 30, 2025: 190,930 shares with a weighted average exercise price of $44.72 and a remaining contractual term of 8.68 years[108] - Share-based compensation expense for stock options: $65,027 (3 months ended June 30, 2025) and $149,501 (6 months ended June 30, 2025)[110] - Unrecognized compensation expense for stock options at June 30, 2025, was $433,190[110] Stock Options for Unregistered Securities This section details non-qualified stock options granted to a former president, including exercise price and vesting - 11,700 non-qualified stock options granted to former President Richard Burch, exercisable at $250.00 per share, 100% vested at grant date, with a remaining contractual term of 5.47 years[111] - No unrecognized compensation expense for these options[111] Underwriters Warrants This section describes outstanding underwriters' warrants, including exercise price and remaining contractual term - Warrants outstanding at June 30, 2025: 7,755 shares with a weighted average exercise price of $279.77 and a remaining contractual term of 0.66 years[114] - No warrant exercises for the six months ended June 30, 2025 and 2024[113] 14 Income Taxes This note provides information on foreign losses, deferred tax expense, net operating loss carryforwards, and tax legislation impact - Foreign loss before taxes for the six months ended June 30, 2025, was $1,165,970, compared to $0 in the prior year, due to acquired Canadian operations[115] - Deferred tax expense for the six months ended June 30, 2025, was $190,691 (foreign component)[117] - As of December 31, 2024, the Company had U.S. federal NOL carryforwards of approximately $36.7 million (indefinite carryforward), state NOLs of $45.8 million (expiring 2037), Canadian non-capital loss carryforwards of $25.3 million (expiring 2025), and Hong Kong tax losses of $58.1 million (no expiry)[117] - The recently enacted One Big Beautiful Bill Act (OBBBA) is not expected to have a material impact on the Company's consolidated financial statements due to substantial NOLs and a full valuation allowance for domestic deferred tax assets[118] Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations This section provides management's perspective on the company's financial condition, operational results, and future outlook CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS This section highlights that the report contains forward-looking statements subject to substantial risks and uncertainties - This report contains forward-looking statements subject to substantial risks and uncertainties, including those detailed in the 2024 Annual Report on Form 10-K[120][121] - Forward-looking statements cover business strategies, regulatory approval, clinical trial timing and costs, reliance on third parties, competitive position, market size, intellectual property, financial condition, liquidity, and growth strategies[122][123] Overview This section provides a high-level summary of the company's business, product pipeline, and strategic focus areas - Dogwood Therapeutics is a pre-revenue, development-stage biopharmaceutical company focused on pain and fatigue-related disorders[124] - Pipeline includes Nav 1.7 modulation (Halneuron® for pain) and combination antiviral therapies (IMC-1, IMC-2 for herpes virus mediated illnesses like fibromyalgia and Long-COVID)[124] Nav 1.7 Non-Opioid Analgesic Program This section details the development of Halneuron® for chemotherapy-induced neuropathic pain, including clinical trial status - Lead product candidate, Halneuron®, is in Phase 2b clinical development (HALT-CINP-203) for chemotherapy-induced neuropathic pain (CINP)[125] - Dosing of patients in HALT-CINP-203 commenced in Q1 2025, targeting approximately 200 patients[126] - Interim analysis of HALT-CINP-203 data (40-50% patient enrollment) is expected in Q4 2025, with top-line data in H2 2026[126] Antiviral Program This section describes the company's antiviral therapies, IMC-1 and IMC-2, targeting fibromyalgia and Long-COVID fatigue - Halneuron® became the primary focus after the October 2024 Combination[127] - IMC-1 (famciclovir + celecoxib) targets fibromyalgia, and IMC-2 (valacyclovir + celecoxib) targets Long-COVID fatigue[127] - FDA agreement on fatigue reduction as an approvable endpoint for Long-COVID candidates like IMC-2[130] - NIH budget cuts for COVID/Long-COVID research create uncertainty for IMC-2 funding and partnerships[130] - Finding a Phase 3 program partner for IMC-1 (fibromyalgia) remains a top business development priority[130] Exchange and Cancellation Agreement This section explains the conversion of a $19.5 million loan from Conjoint Inc. into Series A-1 Preferred Stock - On March 12, 2025, a $19.5 million loan from Conjoint Inc. (plus accrued interest of $426,891) was converted into 284.2638 shares of Series A-1 Non-Voting Convertible Preferred Stock[131][132][15] - Each Series A-1 Preferred Stock share is convertible into 10,000 shares of Common Stock upon stockholder approval[132] Registered Direct Offering This section details the March 2025 registered direct offering, including shares issued and net proceeds generated - On March 14, 2025, the Company closed a registered direct offering of 578,950 shares of Common Stock at $8.26 per share[133] - Gross proceeds: approximately $4.78 million; Net proceeds: approximately $4.25 million[133] Results of Operations This section analyzes the company's financial performance, focusing on changes in research and development and general and administrative expenses Research and Development Expenses This section details the significant increase in R&D expenses, primarily due to the Pharmagesic acquisition and clinical trial costs - R&D expenses increased by $2.2 million for the three months ended June 30, 2025 (from $336,084 to $2,569,943), and by $4.3 million for the six months ended June 30, 2025 (from $679,801 to $5,006,941), compared to prior periods[135][136] - Increases primarily due to the Pharmagesic Combination, HALT-CINP-203 clinical trial costs ($1.6M for 3 months, $3.4M for 6 months), drug development/manufacturing, and personnel costs[136] General and Administrative Expenses This section explains the increase in G&A expenses, driven by legal, professional fees, salaries, and public company costs - G&A expenses increased by $0.6 million for the three months ended June 30, 2025 (from $733,740 to $1,353,172), and by $1.6 million for the six months ended June 30, 2025 (from $1,704,124 to $3,346,100), compared to prior periods[135][137] - Increases primarily due to legal and professional fees ($0.2M for 3 months, $0.8M for 6 months related to Combination), salaries, public company expenses, and franchise tax fees[137] Liquidity and Capital Resources This section assesses the company's ability to meet short-term and long-term obligations, including cash position and financing needs - As of June 30, 2025, cash totaled $13.4 million[138] - Anticipated cash on hand will fund operations through Q1 2026[143] - Additional financing (equity, debt, collaborations) is required beyond Q1 2026, raising substantial doubt about the Company's ability to continue as a going concern[143] - Global economic volatility, including conflicts and sanctions, may hinder timely and favorable financing[139][140] Equity Financings This section summarizes recent equity offerings and the net proceeds generated to support company operations - March 14, 2025: Closed registered direct offering, raising $4.25 million net proceeds[141] - May 22, 2024: Closed public offering, raising $1.4 million net proceeds[141] Debt Financings This section details debt-related activities, including loan proceeds and the conversion of debt into preferred stock - February 18, 2025: Received $3.0 million loan proceeds from Conjoint Inc.[142] - No debt outstanding at June 30, 2025, due to the Debt Exchange and Cancellation Transaction[142] - Debt with related party, net of issuance costs, was $15,381,077 at December 31, 2024[142] Future Capital Requirements This section outlines the company's projected funding needs and the substantial doubt about its going concern ability - Current cash ($13.4M) expected to fund operations through Q1 2026[143] - Requires additional financing beyond Q1 2026 for ongoing clinical trials and operations[143] - Failure to secure financing could materially affect strategy, value, and delay product development[143] Summary of Cash Flows This section provides a high-level overview of cash flows from operating and financing activities | Activity | 2025 ($) | 2024 ($) | | :--- | :--- | :--- | | Operating activities | (8,708,672) | (1,749,160) | | Financing activities | 7,252,245 | 1,452,397 | | Decrease in cash | (1,456,427) | (296,763) | Cash Flows for the Six Months Ended June 30, 2025 and 2024 This section provides a detailed analysis of cash flows from operating and financing activities for the specified periods - Operating Activities (6 months ended June 30, 2025): Net cash used was $8.7 million, driven by a $14.7 million net loss, partially offset by non-cash items ($6.5 million, including $6.1 million loss on debt conversion) and changes in operating assets/liabilities[145] - Operating Activities (6 months ended June 30, 2024): Net cash used was $1.7 million, primarily due to a $2.3 million net loss, partially offset by changes in operating assets/liabilities and share-based compensation[146] - Financing Activities (6 months ended June 30, 2025): Net cash provided was $7.3 million, from $3.0 million loan proceeds and $4.8 million gross proceeds from the March 2025 offering[147] - Financing Activities (6 months ended June 30, 2024): Net cash provided was $1.4 million, from public offering proceeds[148] Off-Balance Sheet Arrangements This section confirms the absence of any off-balance sheet arrangements as of the reporting date - As of June 30, 2025, the Company had no off-balance sheet arrangements[149] Discussion of Critical Accounting Policies and Significant Judgements and Estimates This section confirms no significant changes to critical accounting policies from the prior annual report - No significant changes to critical accounting policies from those described in the 2024 Annual Report on Form 10-K during the six months ended June 30, 2025[150] JOBS Act This section explains the company's status as an emerging growth company and its elected exemptions under the JOBS Act - The Company is an "emerging growth company" under the JOBS Act and has elected to use the extended transition period for new accounting standards[151] - Exemptions include not requiring an auditor's attestation report on internal controls, reduced compensation disclosure, and exemption from mandatory audit firm rotation[152] - These exemptions apply until December 31, 2025, or until the Company no longer meets emerging growth company requirements[153] Item 3. Quantitative and Qualitative Disclosures about Market Risk This item is not required for smaller reporting companies, and thus no disclosures are provided - This item is not required for smaller reporting companies[154] Item 4. Controls and Procedures Management concluded that disclosure controls and procedures were effective, with no material changes in internal control over financial reporting Evaluation of Disclosure Controls and Procedures Management, including CEO and CFO, evaluated and concluded on the effectiveness of disclosure controls and procedures - Management, with CEO and CFO participation, evaluated disclosure controls and procedures as of June 30, 2025[155] - Conclusion: Disclosure controls and procedures were effective in ensuring timely and accurate reporting of required information[156] Changes in Internal Control Over Financial Reporting This section confirms that no material changes occurred in internal control over financial reporting during the quarter - No material changes in internal control over financial reporting occurred during the quarter ended June 30, 2025[157] PART II — OTHER INFORMATION This section provides additional information not covered in the financial statements, including legal, risk, and exhibit details Item 1. Legal Proceedings The company is subject to claims in the ordinary course of business but currently has no pending or ongoing material litigation - No pending or ongoing material litigation as of the report date[160] Item 1A. Risk Factors This section confirms no material changes to the risk factors previously disclosed in the company's 2024 Annual Report - No material changes from risk factors previously disclosed in the 2024 Annual Report on Form 10-K[161] Item 2. Unregistered Sales of Equity Securities and Use of Proceeds This section reports no unregistered sales of equity securities or use of proceeds for the period - None to report[162] Item 3. Defaults Upon Senior Securities This section reports no defaults upon senior securities for the period - None to report[163] Item 4. Mine Safety Disclosures This item is not applicable to the company's operations - Not applicable[164] Item 5. Other Information This section provides other relevant information, including details on Rule 10b5-1 trading arrangements Rule 10b5-1 Trading Arrangements This section confirms no directors or officers adopted or terminated Rule 10b5-1 trading arrangements - No director or officer adopted or terminated any Rule 10b5-1 trading arrangement or non-Rule 10b5-1 trading arrangement during the six months ended June 30, 2025[165] Item 6. Exhibits This section lists all exhibits filed with the Quarterly Report, including certificates, plans, and certifications Exhibit Index This section provides an index of all exhibits, including legal documents, equity plans, and regulatory certifications - Includes Certificate of Designation of Series A-1 Non-Voting Convertible Preferred Stock (March 12, 2025)[169] - Includes Certificate of Validation for Series A Preferred Stock (May 8, 2025)[169] - Lists Dogwood Therapeutics, Inc. Amended and Restated 2020 Equity Incentive Plan, as amended[169] - Contains CEO and CFO certifications pursuant to Sections 302 and 906 of the Sarbanes-Oxley Act of 2002[169] - Includes XBRL Instance Document and Taxonomy Extension Documents[169] Signatures This section confirms the official signing of the report by the Chief Financial Officer and Chief Executive Officer - Report signed on August 13, 2025[172] - Signed by Angela Walsh, Chief Financial Officer, Corporate Secretary and Treasurer[172] - Signed by Greg Duncan, Chairman of the Board of Directors and Chief Executive Officer[174]