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Virios Therapeutics(VIRI) - 2025 Q2 - Quarterly Report
2025-08-13 14:18
[PART I — FINANCIAL INFORMATION](index=3&type=section&id=PART%20I%20%E2%80%94%20FINANCIAL%20INFORMATION) This section presents the unaudited condensed consolidated financial statements and related notes for Dogwood Therapeutics, Inc [Item 1. Financial Statements](index=3&type=section&id=Item%201.%20Financial%20Statements) This section presents unaudited condensed consolidated financial statements and notes, covering balance sheets, operations, equity, and cash flows [Condensed Consolidated Balance Sheets](index=3&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) 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](index=4&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) 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](index=12&type=chunk) [Condensed Consolidated Statements of Changes in Series A Non-Voting Convertible Preferred Stock and Stockholders' Equity (Deficit)](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Changes%20in%20Series%20A%20Non-Voting%20Convertible%20Preferred%20Stock%20and%20Stockholders'%20Equity%20(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: **$6,878,599**[14](index=14&type=chunk) - Total Stockholders' Equity (Deficit) at December 31, 2024: **$(10,124,339)**[14](index=14&type=chunk) - Conversion of loan payable plus interest into Series A-1 Non-Voting Convertible Preferred Stock: **$24,994,461**[14](index=14&type=chunk) - Proceeds from registered direct offering of common stock, net of offering costs: **$4,252,793**[14](index=14&type=chunk) - Accrual of paid-in-kind dividends on Series A Non-Voting Convertible Preferred Stock: **$(1,256,662)**[14](index=14&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) 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](index=15&type=chunk) - Non-cash financing activity: Accrual of paid-in-kind dividends on Series A Non-Voting Convertible Preferred Stock: **$1,256,662**[15](index=15&type=chunk) [Notes to Condensed Consolidated Financial Statements](index=7&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) This section provides detailed explanations and disclosures supporting the condensed consolidated financial statements [1 Organization and Nature of Business](index=7&type=section&id=1%20Organization%20and%20Nature%20of%20Business) 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](index=17&type=chunk) - The Company is a pre-revenue, development-stage biopharmaceutical company focused on developing new medicines for pain and fatigue-related disorders[18](index=18&type=chunk) - 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](index=18&type=chunk) - **Halneuron® Phase 2b CINP study (\"HALT-CINP-203\")** commenced in Q1 2025[18](index=18&type=chunk) - 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](index=19&type=chunk) - Substantial doubt exists about the Company's ability to operate as a going concern beyond **Q1 2026** without additional financing[23](index=23&type=chunk) - 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](index=20&type=chunk)[21](index=21&type=chunk) - On March 14, 2025, the Company closed a registered direct offering, generating approximately **$4.25 million** in net proceeds[22](index=22&type=chunk) [2 Summary of Significant Accounting Policies](index=8&type=section&id=2%20Summary%20of%20Significant%20Accounting%20Policies) 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](index=24&type=chunk) - The Company operates in one reportable segment: development of clinical and preclinical product candidates for pain and fatigue illness[28](index=28&type=chunk) - On October 9, 2024, the Company effected a **25-for-1 reverse stock split**, retroactively adjusted for all periods presented[26](index=26&type=chunk) - 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](index=52&type=chunk)[153](index=153&type=chunk) - 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](index=53&type=chunk)[56](index=56&type=chunk)[57](index=57&type=chunk) [3 Business Combination](index=14&type=section&id=3%20Business%20Combination) 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](index=58&type=chunk)[62](index=62&type=chunk) - Total consideration paid for the acquisition was approximately **$71.3 million**, consisting of common stock (**$893,093**) and Series A Preferred Stock (**$70,372,634**)[63](index=63&type=chunk) Acquired Assets and Assumed Liabilities | Asset/Liability | Amount ($) | | :--- | :--- | | 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](index=17&type=section&id=4%20Prepaid%20Expenses%20and%20Other%20Current%20Assets) 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](index=68&type=chunk) - Significant components at June 30, 2025, include Prepaid clinical research costs (**$795,724**) and Prepaid insurance (**$347,811**)[68](index=68&type=chunk) [5 Property and Equipment](index=17&type=section&id=5%20Property%20and%20Equipment) 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](index=69&type=chunk) [6 License Agreement](index=17&type=section&id=6%20License%20Agreement) 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](index=70&type=chunk) - The agreement is in effect for **25 years** and will terminate on **June 1, 2037**[70](index=70&type=chunk) [7 Accrued Expenses](index=17&type=section&id=7%20Accrued%20Expenses) 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](index=71&type=chunk) - 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](index=71&type=chunk) [8 Leases](index=18&type=section&id=8%20Leases) 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](index=73&type=chunk) - Total lease expense for the six months ended June 30, 2025, was **$55,231**[74](index=74&type=chunk) - Future minimum annual commitments under operating leases total **$210,482**, with a present value of **$186,990**[74](index=74&type=chunk) - Weighted-average remaining lease term is **3.2 years**, with a weighted-average discount rate of **7.82%**[74](index=74&type=chunk) [9 Promissory Note with Related Party](index=18&type=section&id=9%20Promissory%20Note%20with%20Related%20Party) 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](index=75&type=chunk) - The loan bore interest at **SOFR + 2.00%** and was due **October 7, 2027**[77](index=77&type=chunk) - 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](index=78&type=chunk) - A loss on debt extinguishment of **$6,134,120** was recognized due to the conversion[79](index=79&type=chunk) - As of December 31, 2024, the fair value of the related party note payable was approximately **$15.7 million**[80](index=80&type=chunk) [10 Stockholders' Equity](index=19&type=section&id=10%20Stockholders'%20Equity) This note details the company's capital structure, including preferred stock, common stock, and equity financing activities [Preferred Stock](index=19&type=section&id=Preferred%20Stock) 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](index=81&type=chunk) - 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](index=82&type=chunk) [Series A Preferred Stock](index=19&type=section&id=Series%20A%20Preferred%20Stock) 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](index=83&type=chunk) - As of June 30, 2025, **2,269.1494 shares** were issued and outstanding[84](index=84&type=chunk) - 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](index=85&type=chunk) - Each share is convertible into **10,000 shares of Common Stock** upon stockholder approval of the Conversion Proposal, subject to beneficial ownership limitations[87](index=87&type=chunk) - 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](index=87&type=chunk) - Holders received a **5.0% PIK dividend**, with **55.345 shares** issued on April 7, 2025[88](index=88&type=chunk) [Form of Repurchase Agreement](index=20&type=section&id=Form%20of%20Repurchase%20Agreement) 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](index=89&type=chunk)[90](index=90&type=chunk) [Contingent Value Rights Agreement](index=21&type=section&id=Contingent%20Value%20Rights%20Agreement) 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](index=91&type=chunk) - CVR holders are entitled to **87.75%** of any Upfront Payment or Milestone Payment received by the Company quarterly, subject to deductions[92](index=92&type=chunk)[93](index=93&type=chunk) - CVRs are generally non-transferable and do not grant shareholder rights[94](index=94&type=chunk) - 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](index=95&type=chunk) [Series A-1 Preferred Stock](index=21&type=section&id=Series%20A-1%20Preferred%20Stock) 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](index=96&type=chunk) - Ranks on parity with Common Stock for liquidation distributions[97](index=97&type=chunk) - Generally non-voting, but requires majority holder approval for adverse changes to its rights or certain corporate actions[98](index=98&type=chunk)[100](index=100&type=chunk) - Convertible into **10,000 shares of Common Stock** per share upon stockholder approval, subject to beneficial ownership limitations[101](index=101&type=chunk) [Common Stock](index=22&type=section&id=Common%20Stock) 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](index=102&type=chunk) [Registered Direct Offering](index=22&type=section&id=Registered%20Direct%20Offering) 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](index=103&type=chunk) - Gross proceeds were approximately **$4.78 million**, with net proceeds of approximately **$4.25 million**[103](index=103&type=chunk) [11 Related Parties](index=22&type=section&id=11%20Related%20Parties) 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](index=104&type=chunk) - Payments to Gendreau: **$52,000** (3 months ended June 30, 2025) and **$240,577** (6 months ended June 30, 2025)[104](index=104&type=chunk) - 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](index=104&type=chunk) - Conjoint Inc., an affiliate of CKLS, is a related party involved in the **$19.5 million** loan and subsequent debt conversion[104](index=104&type=chunk)[75](index=75&type=chunk) [12 Commitments and Contingencies](index=22&type=section&id=12%20Commitments%20and%20Contingencies) 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](index=105&type=chunk)[106](index=106&type=chunk)[160](index=160&type=chunk) [13 Share-based compensation](index=23&type=section&id=13%20Share-based%20compensation) This note details the company's equity incentive plan, stock options, and warrants, including related expenses [Equity Incentive Plan](index=23&type=section&id=Equity%20Incentive%20Plan) 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](index=107&type=chunk) - As of June 30, 2025, **182 shares** were available for future grants[107](index=107&type=chunk) - 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](index=108&type=chunk) - 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](index=110&type=chunk) - Unrecognized compensation expense for stock options at June 30, 2025, was **$433,190**[110](index=110&type=chunk) [Stock Options for Unregistered Securities](index=24&type=section&id=Stock%20Options%20for%20Unregistered%20Securities) 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](index=111&type=chunk) - No unrecognized compensation expense for these options[111](index=111&type=chunk) [Underwriters Warrants](index=24&type=section&id=Underwriters%20Warrants) 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](index=114&type=chunk) - No warrant exercises for the six months ended June 30, 2025 and 2024[113](index=113&type=chunk) [14 Income Taxes](index=24&type=section&id=14%20Income%20Taxes) 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](index=115&type=chunk) - Deferred tax expense for the six months ended June 30, 2025, was **$190,691** (foreign component)[117](index=117&type=chunk) - 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](index=117&type=chunk) - 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](index=118&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=26&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) This section provides management's perspective on the company's financial condition, operational results, and future outlook [CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS](index=26&type=section&id=CAUTIONARY%20NOTE%20REGARDING%20FORWARD-LOOKING%20STATEMENTS) 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](index=120&type=chunk)[121](index=121&type=chunk) - 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](index=122&type=chunk)[123](index=123&type=chunk) [Overview](index=27&type=section&id=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](index=124&type=chunk) - 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](index=124&type=chunk) [Nav 1.7 Non-Opioid Analgesic Program](index=27&type=section&id=Nav%201.7%20Non-Opioid%20Analgesic%20Program) 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](index=125&type=chunk) - Dosing of patients in HALT-CINP-203 commenced in **Q1 2025**, targeting approximately **200 patients**[126](index=126&type=chunk) - Interim analysis of HALT-CINP-203 data (**40-50% patient enrollment**) is expected in **Q4 2025**, with top-line data in **H2 2026**[126](index=126&type=chunk) [Antiviral Program](index=27&type=section&id=Antiviral%20Program) 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](index=127&type=chunk) - IMC-1 (famciclovir + celecoxib) targets fibromyalgia, and IMC-2 (valacyclovir + celecoxib) targets Long-COVID fatigue[127](index=127&type=chunk) - FDA agreement on fatigue reduction as an approvable endpoint for Long-COVID candidates like IMC-2[130](index=130&type=chunk) - NIH budget cuts for COVID/Long-COVID research create uncertainty for IMC-2 funding and partnerships[130](index=130&type=chunk) - Finding a Phase 3 program partner for IMC-1 (fibromyalgia) remains a top business development priority[130](index=130&type=chunk) [Exchange and Cancellation Agreement](index=28&type=section&id=Exchange%20and%20Cancellation%20Agreement) 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](index=131&type=chunk)[132](index=132&type=chunk)[15](index=15&type=chunk) - Each Series A-1 Preferred Stock share is convertible into **10,000 shares of Common Stock** upon stockholder approval[132](index=132&type=chunk) [Registered Direct Offering](index=28&type=section&id=Registered%20Direct%20Offering) 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](index=133&type=chunk) - Gross proceeds: approximately **$4.78 million**; Net proceeds: approximately **$4.25 million**[133](index=133&type=chunk) [Results of Operations](index=29&type=section&id=Results%20of%20Operations) This section analyzes the company's financial performance, focusing on changes in research and development and general and administrative expenses [Research and Development Expenses](index=29&type=section&id=Research%20and%20Development%20Expenses) 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](index=135&type=chunk)[136](index=136&type=chunk) - 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](index=136&type=chunk) [General and Administrative Expenses](index=29&type=section&id=General%20and%20Administrative%20Expenses) 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](index=135&type=chunk)[137](index=137&type=chunk) - 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](index=137&type=chunk) [Liquidity and Capital Resources](index=29&type=section&id=Liquidity%20and%20Capital%20Resources) 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](index=138&type=chunk) - Anticipated cash on hand will fund operations through **Q1 2026**[143](index=143&type=chunk) - 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](index=143&type=chunk) - Global economic volatility, including conflicts and sanctions, may hinder timely and favorable financing[139](index=139&type=chunk)[140](index=140&type=chunk) [Equity Financings](index=30&type=section&id=Equity%20Financings) 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](index=141&type=chunk) - May 22, 2024: Closed public offering, raising **$1.4 million** net proceeds[141](index=141&type=chunk) [Debt Financings](index=30&type=section&id=Debt%20Financings) 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](index=142&type=chunk) - No debt outstanding at June 30, 2025, due to the Debt Exchange and Cancellation Transaction[142](index=142&type=chunk) - Debt with related party, net of issuance costs, was **$15,381,077** at December 31, 2024[142](index=142&type=chunk) [Future Capital Requirements](index=30&type=section&id=Future%20Capital%20Requirements) This section outlines the company's projected funding needs and the substantial doubt about its going concern ability - Current cash (**$13.4M**) expected to fund operations through **Q1 2026**[143](index=143&type=chunk) - Requires additional financing beyond **Q1 2026** for ongoing clinical trials and operations[143](index=143&type=chunk) - Failure to secure financing could materially affect strategy, value, and delay product development[143](index=143&type=chunk) [Summary of Cash Flows](index=30&type=section&id=Summary%20of%20Cash%20Flows) This section provides a high-level overview of cash flows from operating and financing activities | Activity | 2025 ($) | 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](index=31&type=section&id=Cash%20Flows%20for%20the%20Six%20Months%20Ended%20June%2030,%202025%20and%202024) 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](index=145&type=chunk) - 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](index=146&type=chunk) - 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](index=147&type=chunk) - Financing Activities (6 months ended June 30, 2024): Net cash provided was **$1.4 million**, from public offering proceeds[148](index=148&type=chunk) [Off-Balance Sheet Arrangements](index=31&type=section&id=Off-Balance%20Sheet%20Arrangements) 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](index=149&type=chunk) [Discussion of Critical Accounting Policies and Significant Judgements and Estimates](index=31&type=section&id=Discussion%20of%20Critical%20Accounting%20Policies%20and%20Significant%20Judgements%20and%20Estimates) 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](index=150&type=chunk) [JOBS Act](index=31&type=section&id=JOBS%20Act) 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](index=151&type=chunk) - Exemptions include not requiring an auditor's attestation report on internal controls, reduced compensation disclosure, and exemption from mandatory audit firm rotation[152](index=152&type=chunk) - These exemptions apply until **December 31, 2025**, or until the Company no longer meets emerging growth company requirements[153](index=153&type=chunk) [Item 3. Quantitative and Qualitative Disclosures about Market Risk](index=32&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20about%20Market%20Risk) 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](index=154&type=chunk) [Item 4. Controls and Procedures](index=32&type=section&id=Item%204.%20Controls%20and%20Procedures) 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](index=32&type=section&id=Evaluation%20of%20Disclosure%20Controls%20and%20Procedures) 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](index=155&type=chunk) - Conclusion: Disclosure controls and procedures were effective in ensuring timely and accurate reporting of required information[156](index=156&type=chunk) [Changes in Internal Control Over Financial Reporting](index=32&type=section&id=Changes%20in%20Internal%20Control%20Over%20Financial%20Reporting) 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](index=157&type=chunk) [PART II — OTHER INFORMATION](index=33&type=section&id=PART%20II%20%E2%80%94%20OTHER%20INFORMATION) This section provides additional information not covered in the financial statements, including legal, risk, and exhibit details [Item 1. Legal Proceedings](index=33&type=section&id=Item%201.%20Legal%20Proceedings) 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](index=160&type=chunk) [Item 1A. Risk Factors](index=33&type=section&id=Item%201A.%20Risk%20Factors) 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](index=161&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 reports no unregistered sales of equity securities or use of proceeds for the period - None to report[162](index=162&type=chunk) [Item 3. Defaults Upon Senior Securities](index=33&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) This section reports no defaults upon senior securities for the period - None to report[163](index=163&type=chunk) [Item 4. Mine Safety Disclosures](index=33&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company's operations - Not applicable[164](index=164&type=chunk) [Item 5. Other Information](index=33&type=section&id=Item%205.%20Other%20Information) This section provides other relevant information, including details on Rule 10b5-1 trading arrangements [Rule 10b5-1 Trading Arrangements](index=33&type=section&id=Rule%2010b5-1%20Trading%20Arrangements) 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](index=165&type=chunk) [Item 6. Exhibits](index=33&type=section&id=Item%206.%20Exhibits) This section lists all exhibits filed with the Quarterly Report, including certificates, plans, and certifications [Exhibit Index](index=34&type=section&id=Exhibit%20Index) 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](index=169&type=chunk) - Includes Certificate of Validation for Series A Preferred Stock (**May 8, 2025**)[169](index=169&type=chunk) - Lists Dogwood Therapeutics, Inc. Amended and Restated 2020 Equity Incentive Plan, as amended[169](index=169&type=chunk) - Contains CEO and CFO certifications pursuant to Sections 302 and 906 of the Sarbanes-Oxley Act of 2002[169](index=169&type=chunk) - Includes XBRL Instance Document and Taxonomy Extension Documents[169](index=169&type=chunk) [Signatures](index=35&type=section&id=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](index=172&type=chunk) - Signed by Angela Walsh, Chief Financial Officer, Corporate Secretary and Treasurer[172](index=172&type=chunk) - Signed by Greg Duncan, Chairman of the Board of Directors and Chief Executive Officer[174](index=174&type=chunk)
Virios Therapeutics(VIRI) - 2025 Q2 - Quarterly Results
2025-08-13 13:15
[Executive Summary & Recent Developments](index=1&type=section&id=Executive%20Summary%20%26%20Recent%20Developments) Dogwood Therapeutics reported Q2 2025 progress in its Halneuron® trial and financial position, with CEO and CMO commentary highlighting pipeline potential and target mechanisms [Q2 2025 Highlights](index=1&type=section&id=Q2%202025%20Highlights) Dogwood Therapeutics reported key progress in its Halneuron® Phase 2b trial, including patient enrollment and a low discontinuation rate, with interim data expected in Q4 2025. The company also highlighted its cash position, providing an operational runway through Q1 2026 - Enrollment to-date of **52 patients** in the ongoing Halneuron® Phase 2b Trial for Chemotherapy-Induced Neuropathic Pain (CINP)[1](index=1&type=chunk)[3](index=3&type=chunk) - Halneuron® CINP Phase 2b study interim data readout remains on track for **Q4 2025**[1](index=1&type=chunk) - Low discontinuation rate (**5.8%**) due to adverse events in the first **38 patients** completing the trial, suggesting Halneuron® and placebo treatment have been generally well tolerated[1](index=1&type=chunk) - Cash on hand of **$13.4 million** provides operational runway through **Q1 2026**[1](index=1&type=chunk) [CEO & CMO Commentary](index=1&type=section&id=CEO%20%26%20CMO%20Commentary) The CEO emphasized the potential for Halneuron® to be the first FDA-approved CINP treatment and the opportunity to expand the NaV 1.7 research pipeline to other pain forms. The CMO highlighted the fundamental role of the NaV 1.7 sodium channel in pain transmission as a critical treatment target - CEO Greg Duncan believes Halneuron® has the potential to be the **first and only FDA-approved CINP treatment** and highlights its significant potential to expand the NaV 1.7 research pipeline to other forms of pain, including diabetic peripheral neuropathy, post herpetic neuralgia, and acute surgical pain[2](index=2&type=chunk) - CMO Michael Gendreau, MD, PhD, stated that the NaV 1.7 sodium channel plays a **fundamental role in pain transmission**, making its modulation applicable to both chronic and acute pain states, as evidenced by conditions like Congenital Insensitivity to Pain Syndrome[2](index=2&type=chunk) [Proprietary Pipeline Overview](index=3&type=section&id=Proprietary%20Pipeline%20Overview) Dogwood's pipeline includes Halneuron® for CINP in Phase 2b and an antiviral program with IMC-1 for Fibromyalgia (Phase 3 ready) and IMC-2 for Long-COVID (Phase 2a) [Halneuron® Program](index=3&type=section&id=Halneuron%C2%AE%20Program) Halneuron® is a non-opioid, NaV 1.7 inhibitor in Phase 2b development for chemotherapy-induced neuropathic pain (CINP), having received FDA Fast Track designation. Interim data from the ongoing study are anticipated in Q4 2025 - Halneuron® is in **Phase 2b development** as a non-opioid, NaV 1.7 inhibitor to treat pain conditions, including neuropathic pain associated with chemotherapy treatment[9](index=9&type=chunk) - Halneuron® has been granted **Fast Track designation** from the FDA for the treatment of CINP[9](index=9&type=chunk) - Interim data from the ongoing Phase 2b CINP study are expected in **Q4 2025**[9](index=9&type=chunk) [Antiviral Program](index=3&type=section&id=Antiviral%20Program) Dogwood's antiviral program includes IMC-1 for Fibromyalgia, which is Phase 3 ready with Fast Track designation, and IMC-2 for Long-COVID, currently in Phase 2a, with external funding paused due to government resource clarity issues [IMC-1 (Fibromyalgia)](index=3&type=section&id=IMC-1%20(Fibromyalgia)) IMC-1, a combination antiviral treatment for Fibromyalgia (FM), is ready for Phase 3 development and has received FDA Fast Track designation for FM - IMC-1 (famciclovir + celecoxib) is ready for **Phase 3 development** as a combination antiviral treatment for Fibromyalgia (FM)[9](index=9&type=chunk) - IMC-1 has been granted **Fast Track designation** by the FDA for the treatment of FM[9](index=9&type=chunk) [IMC-2 (Long-COVID)](index=3&type=section&id=IMC-2%20(Long-COVID)) IMC-2, a combination antiviral treatment for Long-COVID, is in Phase 2a development. External research funding and partnership discussions are currently paused due to uncertainties regarding U.S. Government commitment to COVID illness funding. The FDA has agreed to use reduction in fatigue as the primary endpoint for future IMC-2 research - IMC-2 (valacyclovir + celecoxib) is in **Phase 2a development** as a combination antiviral treatment for Long-COVID[9](index=9&type=chunk) - Current external research funding and partnership discussions for IMC-2 have been **paused** due to pervasive reductions in government health funding and a lack of clarity on U.S. Government resources for COVID illness[9](index=9&type=chunk) - The company has reached an agreement with FDA on using **reduction in fatigue as the primary endpoint** for future IMC-2 Long-COVID research[12](index=12&type=chunk) [Second Quarter 2025 Financial Results](index=3&type=section&id=Second%20Quarter%202025%20Financial%20Results) Dogwood Therapeutics reported a significant increase in operating expenses and net loss for Q2 2025, primarily driven by higher R&D and G&A costs [Operating Expenses](index=3&type=section&id=Operating%20Expenses) Operating expenses significantly increased in Q2 2025 compared to Q2 2024, primarily driven by higher research and development costs related to clinical trials and general and administrative expenses due to legal, accounting, and public company costs [Research and Development Expenses](index=3&type=section&id=Research%20and%20Development%20Expenses) Research and development expenses for Q2 2025 increased by $2.2 million year-over-year, primarily due to the business combination with Pharmagesic, leading to higher clinical trial, drug development, and personnel costs Research and Development Expenses (Q2 2025 vs Q2 2024) | Metric | Q2 2025 | Q2 2024 | Change | | :------------------- | :-------- | :-------- | :----- | | R&D Expenses | $2.5 million | $0.3 million | +$2.2 million | - The **$2.2 million increase** was primarily due to the business combination with Pharmagesic, including increases in expenses for clinical trials (**$1.6 million** related to Halneuron® CINP Phase 2b study), drug development and manufacturing costs (**$0.5 million**), and salaries and related personnel costs (**$0.2 million**), offset by a decrease in regulatory costs (**$0.1 million**)[6](index=6&type=chunk) [General and Administrative Expenses](index=3&type=section&id=General%20and%20Administrative%20Expenses) General and administrative expenses for Q2 2025 rose by $0.6 million compared to Q2 2024, mainly driven by increased legal and accounting fees, personnel costs, and expenses associated with being a public company General and Administrative Expenses (Q2 2025 vs Q2 2024) | Metric | Q2 2025 | Q2 2024 | Change | | :------------------- | :-------- | :-------- | :----- | | G&A Expenses | $1.3 million | $0.7 million | +$0.6 million | - The **$0.6 million increase** was primarily due to increases in legal and accounting fees (**$0.2 million**), salaries and related personnel costs (**$0.2 million**), expenses associated with being a public company (**$0.1 million**), and other general and administrative costs (**$0.1 million**)[7](index=7&type=chunk) [Net Loss and EPS](index=3&type=section&id=Net%20Loss%20and%20EPS) Dogwood Therapeutics reported a significantly higher net loss attributable to common stockholders in Q2 2025, reaching $3.8 million, compared to $1.0 million in Q2 2024, resulting in a basic and diluted net loss per share of $1.99 Net Loss and EPS (Q2 2025 vs Q2 2024) | Metric | Q2 2025 | Q2 2024 | | :--------------------------------------- | :-------- | :-------- | | Net Loss Attributable to Common Stockholders | $(3.8) million | $(1.0) million | | Basic and Diluted Net Loss Per Share | $(1.99) | $(1.15) | [Financial Statements](index=8&type=section&id=Financial%20Statements) The financial statements reveal increased operating expenses and net losses for Q2 2025, alongside a stronger balance sheet with improved stockholders' equity [Condensed Statements of Operations](index=8&type=section&id=Condensed%20Statements%20of%20Operations) The condensed statements of operations show a significant increase in operating expenses and net loss for both the three and six months ended June 30, 2025, compared to the prior year, primarily driven by increased R&D and G&A costs, and a substantial loss on debt conversion for the six-month period Condensed Statements of Operations Data (Three Months Ended June 30) | Statements of Operations Data | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | | :---------------------------- | :------------------------------- | :------------------------------- | | Revenue | $ — | $ — | | Research and development | $2,569,943 | $336,084 | | General and administrative | $1,353,172 | $733,740 | | Total operating expenses | $3,923,115 | $1,069,824 | | Loss from operations | $(3,923,115) | $(1,069,824) | | Total other income (expense), net | $115,911 | $19,991 | | Loss before income taxes | $(3,807,204) | $(1,049,833) | | Deferred income tax provision | $(149) | $— | | Net Loss | $(3,807,353) | $(1,049,833) | | Net loss attributable to common stockholders | $(3,807,353) | $(1,049,833) | | Net loss per share of common stock — basic and diluted | $(1.99) | $(1.15) | | Weighted average shares outstanding — basic and diluted | 1,911,128 | 916,031 | Condensed Statements of Operations Data (Six Months Ended June 30) | Statements of Operations Data | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :---------------------------- | :------------------------------- | :------------------------------- | | Revenue | $ — | $ — | | Research and development | $5,006,941 | $679,801 | | General and administrative | $3,346,100 | $1,704,124 | | Total operating expenses | $8,353,041 | $2,383,925 | | Loss from operations | $(8,353,041) | $(2,383,925) | | Loss on debt conversion with related party | $(6,134,120) | $— | | Interest income (expense), net | $(35,711) | $42,757 | | Exchange gain (loss), net | $(18,742) | $— | | Total other income (expense), net | $(6,188,573) | $42,757 | | Loss before income taxes | $(14,541,614) | $(2,341,168) | | Deferred income tax provision | $(190,691) | $— | | Net Loss | $(14,732,305) | $(2,341,168) | | Accrual of paid-in kind dividends on Series A non-voting convertible preferred stock | $(1,256,662) | $— | | Net loss attributable to common stockholders | $(15,988,967) | $(2,341,168) | | Net loss per share of common stock — basic and diluted | $(9.51) | $(2.78) | | Weighted average shares outstanding — basic and diluted | 1,680,827 | 843,174 | [Condensed Consolidated Balance Sheet](index=10&type=section&id=Condensed%20Consolidated%20Balance%20Sheet) As of June 30, 2025, Dogwood Therapeutics reported $13.4 million in cash, total assets of $96.7 million, and a significant improvement in stockholders' equity, moving from a deficit of $10.1 million at December 31, 2024, to a positive $6.9 million Condensed Consolidated Balance Sheet Data | Data | June 30, 2025 | December 31, 2024 | | :-------------------------- | :-------------- | :---------------- | | Cash | $13,402,809 | $14,847,949 | | Total assets | $96,692,527 | $94,308,246 | | Total liabilities | $14,151,904 | $30,027,223 | | Total stockholders' equity (deficit) | $6,878,599 | $(10,124,339) | [About Dogwood Therapeutics](index=5&type=section&id=About%20Dogwood%20Therapeutics) Dogwood Therapeutics is a development-stage biopharmaceutical company focused on developing new medicines for pain and fatigue-related disorders. Its research pipeline includes a non-opioid analgesic program, with Halneuron® as its lead candidate, and an antiviral program featuring IMC-1 and IMC-2 for conditions like fibromyalgia and Long-COVID - Dogwood Therapeutics (Nasdaq: DWTX) is a development-stage biopharmaceutical company focused on developing new medicines to treat **pain and fatigue-related disorders**[11](index=11&type=chunk) - The Dogwood research pipeline includes **two separate mechanistic platforms**: a non-opioid analgesic program and an antiviral program[11](index=11&type=chunk) - The non-opioid, NaV 1.7 analgesic program is centered on Halneuron®, a highly specific voltage-gated sodium channel modulator, which has demonstrated **pain reduction** in general cancer pain and chronic chemotherapy-induced neuropathic pain (CINP)[11](index=11&type=chunk) - The antiviral program includes IMC-1 and IMC-2, novel, proprietary, fixed-dose combinations of anti-herpes antivirals and celecoxib, applied to illnesses believed to be related to reactivation of previously dormant herpesviruses, such as **fibromyalgia (FM) and Long-COVID (LC)**[12](index=12&type=chunk) [Forward-Looking Statements](index=5&type=section&id=Forward-Looking%20Statements) This section contains standard forward-looking statements, subject to substantial risks and uncertainties, as defined by the U.S. Private Securities Litigation Reform Act of 1995. These statements are based on current expectations and assumptions, with risks detailed in the company's Form 10-K, and Dogwood undertakes no obligation to update them except as required by law - Statements in this press release are "**forward-looking statements**" under the U.S. Private Securities Litigation Reform Act of 1995, subject to substantial risks and uncertainties[14](index=14&type=chunk) - Forward-looking statements are based on Dogwood's current expectations and are subject to inherent uncertainties, risks, and assumptions, including those related to the **completion, timing, and results of current and future clinical studies**[14](index=14&type=chunk) - These risks and uncertainties are described more fully in the "**Risk Factors**" section of the Annual Report on Form 10-K for the year ended December 31, 2024[16](index=16&type=chunk) - Dogwood undertakes **no duty to update** such information except as required under applicable law[16](index=16&type=chunk) [Investor Relations](index=7&type=section&id=Investor%20Relations) This section provides contact information for investor relations inquiries - Investor Relations contact: **CORE IR, (516) 222-2560, IR@dwtx.com**[17](index=17&type=chunk)
Viridien: 2025 Interim Financial Report available
Globenewswire· 2025-07-31 17:17
Core Viewpoint - Viridien has filed its interim financial report for the period ending June 30, 2025, with the Autorité des Marchés Financiers (AMF), indicating ongoing transparency and compliance with regulatory requirements [3]. Company Overview - Viridien is an advanced technology, digital, and Earth data company focused on sustainable solutions for complex challenges in natural resources, energy transition, and infrastructure [4]. - The company employs approximately 3,400 people globally and is listed on Euronext Paris SA under the ticker VIRI [4]. Financial Reporting - The interim financial report is accessible on the company's website, specifically in the Investors section under "Regulated information" and "Results and Publications" [3]. Contact Information - The legal department can be contacted at the registered office located at 27 avenue Carnot, 91300 Massy [5].
2025 second-quarter results Solid performance amid a volatile environment Annual Net Cash Flow objective reaffirmed
GlobeNewswire News Room· 2025-07-31 15:45
Core Insights - Viridien reported solid performance in Q2 2025, achieving a net cash flow of $30 million, reaffirming its full-year target of $100 million despite a volatile market environment [2][20]. Financial Performance - Q2 2025 revenue reached $234 million, a decrease of 26% year-on-year, while adjusted EBITDAs were $68 million, down 55% [12][30]. - The company generated a net cash flow of $30 million in Q2 2025, compared to a negative cash flow of $6 million in Q2 2024 [14][30]. - Net income for Q2 2025 was $6 million, a significant drop from $35 million in Q2 2024 [12][30]. Segment Performance - Geoscience segment revenue was $115 million, up 10% year-on-year, driven by increased demand for high-quality subsurface imaging [7][31]. - Data, Digital and Energy Transition (DDE) segment revenue was $181 million, reflecting a 3% increase year-on-year, primarily due to Geoscience [4][31]. - Sensing and Monitoring (SMO) segment revenue increased by 14% to $93 million, with strong performance in land activities [9][31]. Operational Highlights - The company achieved a 39% margin in adjusted EBITDAs for the Geoscience segment, an increase of approximately 270 basis points year-on-year [6][31]. - Earth Data segment adjusted EBITDAs reached $101 million, up 6% year-on-year, benefiting from improved margins following the end of a vessel capacity agreement [8][31]. - The company has a healthy Geoscience backlog of $317 million, up 29% from the previous year [32]. Cash Flow and Debt Management - The company reported a total net cash flow of $10 million for the first half of 2025, with significant pressure on working capital due to overdue receivables from PEMEX [14][18]. - Net debt increased by 8% to $997 million as of June 30, 2025, compared to $921 million at the end of 2024 [18][37]. - A successful refinancing effort extended bond maturity to October 2030, providing ample liquidity with a $125 million revolving credit facility [14][18]. Market Outlook - The oil price environment remains volatile but consistently above $60 per barrel, supporting exploration and development commitments from oil and gas companies [20][23]. - Viridien expects to maintain momentum in its operations, driven by a strong backlog and anticipated licensing activities towards year-end [2][20].
2025 second-quarter results Solid performance amid a volatile environment Annual Net Cash Flow objective reaffirmed
Globenewswire· 2025-07-31 15:45
Core Insights - Viridien reported solid performance in Q2 2025, achieving a net cash flow of $30 million, reaffirming its full-year target of $100 million despite a volatile environment [2][21] - The company experienced year-on-year growth in segment revenue and margins, driven by a focus on offshore markets and leading oil companies [2][7] Financial Performance - Segment revenue for Q2 2025 was $274 million, up 6% from $258 million in Q2 2024, while H1 2025 revenue increased by 8% to $575 million [30] - Adjusted EBITDAs for Q2 2025 reached $107 million, a 14% increase year-on-year, with a margin of 39% [7][30] - Consolidated IFRS revenue for Q2 2025 was $234 million, down 26% from $317 million in Q2 2024, with EBITDAs at $68 million, a decrease of 55% [13][30] Segment Performance - Data, Digital and Energy Transition (DDE) segment revenue was $181 million in Q2 2025, a 3% increase year-on-year, driven by Geoscience [4][30] - Geoscience (GEO) segment revenue was $115 million, up 10% from $105 million in Q2 2024, with a strong backlog supporting future growth [30] - Sensing and Monitoring (SMO) segment revenue increased by 14% to $93 million, primarily driven by land segment activities [10][30] Cash Flow and Debt Management - The company generated a net cash flow of $30 million in Q2 2025, with a total of $10 million for H1 2025, despite significant working capital pressures [15][18] - Net debt increased by 6% to $997 million as of June 30, 2025, compared to $941 million at the end of 2024 [19][30] - Bond maturity was extended to October 2030 following successful refinancing, with $125 million available in revolving credit facilities [7][18] Market Outlook - The oil price environment remains volatile but consistently above $60 per barrel, supporting exploration and development commitments from oil and gas companies [21] - Viridien expects to maintain momentum in generating cash flow, supported by a healthy Geoscience backlog and anticipated licensing activity [2][21]
Announcement of Q2 2025 Financial Results on Thursday, July 31, after market close
Globenewswire· 2025-07-17 05:30
Core Viewpoint - Viridien is set to announce its second quarter 2025 financial results on July 31, after market close, indicating a significant upcoming event for stakeholders [1]. Company Overview - Viridien is an advanced technology, digital, and Earth data company focused on sustainable solutions for complex challenges in natural resources, digital, energy transition, and infrastructure [3]. - The company employs approximately 3,400 people globally and is listed on Euronext Paris SA under the ticker VIRI [3]. Conference Call Details - Participants must register for the conference call to receive a dial-in number and PIN code, with options to join via live webcast [2]. - A replay of the conference call will be available for 12 months in audio format on the company's website [2]. - The press release and presentation will be accessible on the company's website at 5:45 PM (CET) on July 31, followed by an English-language conference call at 6:00 PM (CET) [6].
Viridien sets new seismic data acquisition standard with launch of Sercel Accel – the world’s first onshore drop node solution
Globenewswire· 2025-06-03 05:30
Core Insights - Viridien has launched the Sercel Accel, the first onshore drop node solution aimed at transforming land seismic data acquisition [1][5] - The Accel solution significantly reduces deployment time and labor requirements, enhancing operational efficiency and reducing costs by up to 30% [2][5] Product Features - Accel eliminates the need for nodes to be buried or planted, streamlining logistics and improving in-field agility [2] - The solution is powered by the Sercel QuietSeis MEMS sensor, ensuring total data integrity and reliability [3] - Accel includes modular Solution Packs that combine nodes, software, and services, allowing customization based on project needs [4] Company Overview - Viridien is a technology and Earth data company focused on sustainable solutions for natural resources and infrastructure challenges, employing around 3,400 people globally [6]
Virios Therapeutics(VIRI) - 2025 Q1 - Quarterly Report
2025-05-09 15:28
Part I: Financial Information [Item 1. Consolidated Financial Statements](index=3&type=section&id=Item%201.%20Consolidated%20Financial%20Statements) This section presents the unaudited condensed consolidated financial statements for Q1 2025, detailing a **$10.9 million net loss**, **$97.0 million total assets**, and financing activities that improved equity and Nasdaq compliance, despite going concern doubts [Condensed Consolidated Balance Sheets](index=3&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) Condensed Consolidated Balance Sheet Highlights (Unaudited) | Account | March 31, 2025 ($) | December 31, 2024 ($) | | :--- | :--- | :--- | | Cash | $17,539,004 | $14,847,949 | | Total Assets | $96,984,688 | $94,308,246 | | Total Liabilities | $14,235,733 | $30,027,223 | | Total Stockholders' Equity (Deficit) | $7,086,931 | $(10,124,339) | [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=4&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) Condensed Consolidated Statements of Operations (Unaudited) | Account | Three Months Ended March 31, 2025 ($) | Three Months Ended March 31, 2024 ($) | | :--- | :--- | :--- | | Revenue | $0 | $0 | | Research and development | $2,436,998 | $343,717 | | General and administrative expenses | $1,992,928 | $970,384 | | Loss from operations | $(4,429,926) | $(1,314,101) | | Loss on debt conversion with related party | $(6,134,120) | $0 | | Net loss | $(10,924,952) | $(1,291,335) | | Net loss per common share, basic and diluted | $(8.45) | $(1.68) | [Condensed Consolidated Statements of Changes in Series A Non-Voting Convertible Preferred Stock and Stockholders' Equity (Deficit)](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Changes%20in%20Stockholders%27%20Equity%20%28Deficit%29) - Stockholders' equity (deficit) improved from a deficit of **$(10.1) million** at year-end 2024 to positive equity of **$7.1 million** at March 31, 2025, primarily driven by the conversion of debt into **$25.0 million** of Series A-1 Preferred Stock and **$4.3 million** in net proceeds from a common stock offering, which offset the **$10.9 million** net loss for the quarter[14](index=14&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Condensed Consolidated Statements of Cash Flows (Unaudited) | Cash Flow Activity | Three Months Ended March 31, 2025 ($) | Three Months Ended March 31, 2024 ($) | | :--- | :--- | :--- | | Net cash used in operating activities | $(4,682,554) | $(937,414) | | Net cash provided by financing activities | $7,372,378 | $0 | | Net increase (decrease) in cash | $2,689,824 | $(937,414) | | Cash, end of period | $17,539,004 | $2,379,532 | [Notes to Condensed Consolidated Financial Statements](index=7&type=section&id=Notes%20to%20Condensed%20Financial%20Statements) These notes detail accounting policies, the company's pre-revenue biopharmaceutical nature, significant development risks, and substantial doubt about going concern, alongside the Pharmagesic acquisition and Q1 2025 financing activities crucial for Nasdaq compliance - The company is a pre-revenue, development-stage biopharmaceutical company focused on developing medicines for pain and fatigue-related disorders, with a pipeline including Halneuron® for pain and antiviral therapies IMC-1 and IMC-2[19](index=19&type=chunk) - Management has concluded there is substantial doubt about the Company's ability to operate as a going concern for at least 12 months from the financial statement issuance date, as current cash is insufficient to fund operations beyond Q1 2026[24](index=24&type=chunk) - In March 2025, the company converted **$19.5 million** in principal and **$0.4 million** in accrued interest from a related-party loan into 284.2638 shares of Series A-1 Preferred Stock, resulting in a **$6.1 million** loss on debt extinguishment[83](index=83&type=chunk)[86](index=86&type=chunk) - In March 2025, the company raised approximately **$4.25 million** in net proceeds through a registered direct offering of 578,950 shares of common stock at **$8.26 per share**[23](index=23&type=chunk)[110](index=110&type=chunk) - The company regained compliance with Nasdaq's minimum stockholders' equity requirement on April 8, 2025, following the debt conversion and equity offering[25](index=25&type=chunk)[26](index=26&type=chunk)[141](index=141&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=25&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the company's financial condition and operational results, highlighting its pre-revenue biopharmaceutical status, increased R&D and G&A expenses, and liquidity challenges with **$17.5 million cash** funding operations only through Q1 2026, raising going concern doubts - The company's lead product candidate, Halneuron®, commenced its Phase 2b clinical trial (HALT-CINP-203) in Q1 2025 for chemotherapy-induced neuropathic pain, with an interim analysis expected in Q4 2025 and top-line data anticipated in the second half of 2026[129](index=129&type=chunk) Operating Expense Comparison (Q1 2025 vs. Q1 2024) | Expense Category | Q1 2025 ($) | Q1 2024 ($) | Change ($) | | :--- | :--- | :--- | :--- | | Research and Development | $2.4 million | $0.3 million | +$2.1 million | | General and Administrative | $2.0 million | $1.0 million | +$1.0 million | - The increase in R&D expenses was primarily due to **$1.8 million** in costs for the HALT-CINP-203 study, while the rise in G&A expenses was driven by **$0.6 million** in legal/professional fees related to the Combination and increased personnel costs[143](index=143&type=chunk)[144](index=144&type=chunk) - As of March 31, 2025, the company had **$17.5 million** in cash, which is anticipated to fund operations only through the first quarter of 2026, raising substantial doubt about the company's ability to continue as a going concern[145](index=145&type=chunk)[150](index=150&type=chunk) [Item 3. Quantitative and Qualitative Disclosures about Market Risk](index=31&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20about%20Market%20Risk) As a smaller reporting company, the company is not required to provide disclosures on quantitative and qualitative market risk - This item is not required for smaller reporting companies[162](index=162&type=chunk) [Item 4. Controls and Procedures](index=31&type=section&id=Item%204.%20Controls%20and%20Procedures) Management, including the CEO and CFO, concluded that disclosure controls and procedures were effective as of March 31, 2025, with no material changes to internal control over financial reporting during the quarter - Based on an evaluation as of the end of the reporting period, the CEO and CFO concluded that the company's disclosure controls and procedures were effective[164](index=164&type=chunk) - There were no changes in internal control over financial reporting during the quarter that materially affected, or are reasonably likely to materially affect, such controls[165](index=165&type=chunk) Part II: Other Information [Item 1. Legal Proceedings](index=32&type=section&id=Item%201.%20Legal%20Proceedings) The company reports no pending or ongoing material legal proceedings - The company does not currently have any pending or ongoing material litigation[167](index=167&type=chunk) [Item 1A. Risk Factors](index=32&type=section&id=Item%201A.%20Risk%20Factors) This section refers readers to the detailed risk factors outlined in the company's 2024 Annual Report on Form 10-K - Readers are referred to the risk factors section of the 2024 Annual Report on Form 10-K for information on risks that could materially affect the business[168](index=168&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=32&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company reported no unregistered sales of equity securities or use of proceeds during the period - None reported[169](index=169&type=chunk) [Item 3. Defaults Upon Senior Securities](index=32&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) The company reported no defaults upon senior securities - None reported[170](index=170&type=chunk) [Item 4. Mine Safety Disclosures](index=32&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company's operations - Not applicable[171](index=171&type=chunk) [Item 5. Other Information](index=32&type=section&id=Item%205.%20Other%20Information) This section discloses no Rule 10b5-1 trading arrangement changes by directors or officers, and the board's ratification of a Series A Preferred Stock dividend payment on May 8, 2025 - No director or officer adopted or terminated a Rule 10b5-1 trading arrangement during the three months ended March 31, 2025[172](index=172&type=chunk) - On May 8, 2025, the board of directors ratified the payment of a dividend of 55.345 shares of Series A Preferred Stock to holders of Series A Preferred Stock[173](index=173&type=chunk) [Item 6. Exhibits](index=32&type=section&id=Item%206.%20Exhibits) This section refers to the Exhibit Index, listing all documents filed as exhibits with this Quarterly Report on Form 10-Q - Refers to the Exhibit Index for a list of filed documents[174](index=174&type=chunk)
Virios Therapeutics(VIRI) - 2025 Q1 - Quarterly Results
2025-05-08 13:20
Financial Performance - Net loss attributable to common stockholders for Q1 2025 was $12.2 million, or $8.45 per share, compared to a net loss of $1.3 million, or $1.68 per share, in Q1 2024[9] - Research and development expenses for Q1 2025 were $2.4 million, a significant increase of 700% compared to $0.3 million in Q1 2024, primarily due to clinical trial expenses[7] - General and administrative expenses for Q1 2025 were $2.0 million, up 100% from $1.0 million in Q1 2024, driven by increased legal and accounting fees[8] Cash and Assets - Cash on hand as of March 31, 2025, was $17.5 million, providing operational runway through Q1 2026[4] - Total assets increased to $96.98 million as of March 31, 2025, compared to $94.31 million at the end of 2024[20] - Total liabilities decreased to $14.24 million as of March 31, 2025, down from $30.03 million at the end of 2024[20] Regulatory and Development Updates - Dogwood Therapeutics commenced dosing in its Halneuron® Phase 2b Chemotherapy Induced Neuropathic Pain program, aiming to be the first FDA approved therapy for this condition[3] - Halneuron® has been granted fast track designation by the FDA for the treatment of chemotherapy induced neuropathic pain, with interim data expected in Q4 2025[10] Shareholder and Equity Changes - An affiliate of the company's largest shareholder converted a $19.5 million loan into equity, improving the company's balance sheet[3] - The company received confirmation from Nasdaq that it has regained compliance with the minimum stockholders' equity requirement of $2.5 million[5]
Viridien secures sale of Sercel Marlin Offshore Logistics solution to ONGC
Globenewswire· 2025-05-06 05:30
Core Insights - Viridien has sold its Sercel Marlin™ Offshore Logistics management solution to Oil and Natural Gas Corporation (ONGC) to improve operational efficiency and safety in ONGC's Western offshore exploration and production (E&P) operations in India [1][2] - The deal includes a five-year contract for dedicated on-premises software and support services, which will enhance ONGC's logistics through real-time vessel tracking and improved operational planning [1][2] - The integration of advanced AI and machine learning algorithms in the Sercel Marlin solution aims to future-proof ONGC's operations and support its carbon neutrality objectives [2][3] Company Overview - Viridien is a technology and digital company focused on Earth data, aiming to resolve complex challenges in natural resources, energy transition, and infrastructure [4] - The company employs approximately 3,400 people globally and is listed on Euronext Paris SA under the ticker VIRI [4]