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PresentationAt this time, I'd like to turn the call over to Greg Duncan, Chief Executive Officer for Dogwood Therapeutics. Please proceed, Mr. Duncan.Good morning, and welcome to today's Dogwood Therapeutics, Inc. Investor Call. [Operator Instructions] And please be advised that today's call is being recorded at the company's request.Greg DuncanChairman & CEO Thank you. Good morning all, and thank you for joining today's exciting investor call for Dogwood Therapeutics. I'm pleased to be joined by our Chief ...

Summary of Dogwood Therapeutics Investor Call - September 29, 2025 Company Overview - **Company**: Dogwood Therapeutics (NasdaqCM: DWTX) - **Focus**: Development of treatments for chemotherapy-induced peripheral neuropathy (CIPN) and cancer-related pain Key Points Industry and Market Context - **CIPN Prevalence**: Approximately 70% of cancer patients undergoing chemotherapy experience neuropathy, with 30% suffering long-term effects six months post-treatment [18] - **Market Opportunity**: The global market for CIPN treatments is estimated at $1.5 billion, with potential expansion into cancer-related pain markets [34] Core Developments - **SP16 License**: Dogwood has secured a global license to develop and commercialize SP16, a first-in-class LRP1 agonist, which is expected to complement the lead compound Halneuron [3][4] - **Halneuron**: A Nav1.7 sodium channel inhibitor currently in a Phase 2b study for CIPN, showing promise in reducing pain without addiction or tolerance [6][8][9] Clinical Trials and Research - **Halneuron Phase 2b Study**: - 82 patients enrolled, targeting a total of 200 [10][11] - Primary endpoint: Average pain score reduction at week four [10] - Safety profile confirmed with only two dropouts [12] - **SP16 Phase 1b Trial**: - Funded by the National Cancer Institute (NCI), with dosing planned to coincide with chemotherapy [14][41] - Focus on safety and tolerability as primary endpoints, with secondary endpoints assessing neuropathic symptoms [41][42] Scientific Insights - **Mechanism of Action**: SP16 exhibits anti-inflammatory and analgesic effects, potentially protecting against nerve damage caused by chemotherapy [4][13][24] - **Preclinical Evidence**: Studies indicate SP16 can reduce hypersensitivity and promote nerve recovery in models of chemotherapy-induced damage [26][28] Financial and Transactional Aspects - **Transaction Structure**: The SP16 deal is an all-stock transaction with no royalties or future development milestones required [40] - **Ownership Implications**: Serpent Pharma will hold approximately 7.31% of Dogwood's stock post-transaction [15][16] Future Outlook - **Milestones**: - Filing of new synthetic IP for Halneuron expected in Q4 2025 [36] - IND filing for SP16 planned for Q4 2025, with patient enrollment in the first half of 2026 [36][51] - **Strategic Positioning**: The combination of Halneuron and SP16 is anticipated to enhance market penetration and create unique revenue pathways [34][35] Additional Considerations - **Expertise**: The management team has a strong background in developing and commercializing pain and neuropathy treatments, having previously worked on drugs like Celebrex and Lyrica [16] - **Community Engagement**: High interest from the medical community in the ongoing trials, reflecting the urgent need for effective treatments for CIPN [12] Conclusion Dogwood Therapeutics is positioned to make significant advancements in the treatment of chemotherapy-induced peripheral neuropathy and cancer-related pain through its innovative pipeline, particularly with the addition of SP16 to its portfolio. The company is focused on leveraging its clinical trials and strategic partnerships to address a critical unmet need in oncology care.

Halneuron® Program - Halneuron® is undergoing a 4-week Phase 2b CINP study, with 80 patients currently randomized to treatment[7] - The Phase 2b study aims to assess the safety and efficacy of Halneuron® in treating moderate-to-severe CINP[9] - The target enrollment for the Phase 2b study is 200 patients, with a potential modification after an interim analysis in Q4 2025[11] - Halneuron® has shown pain relief of approximately 2 months in previous Phase 2 studies, with acceptable safety in over 700 patients[6] - The company plans to file new synthetic Halneuron® IP in Q4 2025 to support Phase 3 and commercialization[39] SP16 Program - The company acquired a royalty-free, global license for Serpin Pharma's SP16 IV formulation to treat neuropathy[13] - Serpin Pharma will receive approximately 382,000 common shares and approximately 179 preferred (A-2) shares, representing a projected 7.31% ownership of DWTX stock on a fully diluted basis, pending a shareholder vote[16] - CKLS ownership is projected to be approximately 83.00% on a fully diluted basis[16] - SP16 is poised to enter a Phase 1b study for CIPN, fully funded by the National Cancer Institute (NCI), with patient enrollment expected to begin in the first half of 2026[13,39] Strategic Rationale - The combined Halneuron® and SP16 programs aim to penetrate the global CINP treatment market, estimated at approximately $1.5 billion[38]

-A first-in-class LRP1 agonist, SP16 phase 1b Chemotherapy Induced Neuropathy (CIPN) Study fully funded by the National Cancer Institute, with projected patient enrollment beginning in the first half of 2026- -SP16 has demonstrated both anti-inflammatory and neural repair activity that has the potential to treat CIPN, synergistically complementing Halneuron®, the Company’s late stage NaV1.7 inhibitor, which has demonstrated significant pain reduction in previous Phase 2 studies- -Webcast today, September 29 ...

智通财经APP讯，长江生命科技(00775)发布公告，诚如首份公告所披露，根据售股协议，向卖方(本公 司全资附属公司)发行买方普通股付款股份及买方Dogwood Therapeutics, Inc(纳斯达克：DWTX)优先股 付款股份乃作为向买方出售目标公司(Pharmagesic (Holdings) Inc)100%股权的代价，及买方优先股付款 股份为卖方提供现金结算权及回购权。于2025年9月26日，卖方与买方订立弃权协议，双方同意就部分 买方优先股付款股份放弃现金结算权及回购权。 诚如首份公告所披露，该等交易导致由目标公司全资拥有的 WEX 与买方进行业务合并。此举让 WEX 可接触买方在医药(包括痛楚舒缓及疼痛相关疾病之药物)的生物科技集资、研发及商品化方面拥有丰富 经验的稳健管理团队。预期在纳入买方的技术、药物研发及产品商品化专长后， WEX 旗舰候选产品 Halneuron® 将能提前公布数据，并加快进入市场。买方作为一家在纳斯达克上市的实体，亦将获准进 入美国资本市场，从而获得更多资金以加快研发 Halneuron® 。本公司透过其于买方所持有的重大权 益，将能获得在买方许可範围内加快研发 H ...

长江生命科技(00775)发布公告，诚如首份公告所披露，根据售股协议，向卖方(本公司全资附属公司)发 行买方普通股付款股份及买方Dogwood Therapeutics,Inc(纳斯达克：DWTX)优先股付款股份乃作为向买 方出售目标公司(Pharmagesic(Holdings)Inc)100%股权的代价，及买方优先股付款股份为卖方提供现金结 算权及回购权。于2025年9月26日，卖方与买方订立弃权协议，双方同意就部分买方优先股付款股份放 弃现金结算权及回购权。 (a)买方将有权要求卖方就买方对买方优先股付款股份所确定的部分放弃现金结算权及回购权，而卖方 同意放弃上述权利，惟须受弃权协议的条款及条件所规限; (b)买方可不时行使其权利，惟不多于每个历季一次; (c)受弃权规限的买方优先股股份(弃权股份)的价值，应根据买方就250万美元与买方于发出弃权通知所 属历季结束时资产负债表上的持股人权益之间的差额进行的真诚估算;及 (d)所有弃权股份的总数不得超过300股(弃权门槛)。 诚如首份公告所披露，该等交易导致由目标公司全资拥有的WEX与买方进行业务合并。此举让WEX可 接触买方在医药(包括痛楚舒缓及疼痛相关 ...

Summary of Dogwood Therapeutics (DWTX) FY Conference Call Company Overview - **Company Name**: Dogwood Therapeutics - **Industry**: Biotechnology - **Focus**: Development of novel non-opioid pain treatments targeting the NAV1.7 sodium channel for chronic pain management, particularly in cancer-related pain and chemotherapy-induced neuropathic pain [1][2][3] Core Product: Halneuron® - **Description**: Halneuron® is a NAV1.7 inhibitor, an injectable therapy aimed at reducing pain associated with cancer and chemotherapy-induced neuropathy [1][5] - **Clinical Stage**: Currently in phase 2b study [1] - **Target Patient Group**: Patients experiencing moderate to severe neuropathic pain post-chemotherapy, with about 70% of chemotherapy patients experiencing neuropathy [2][10] Clinical Data and Results - **Unmet Medical Need**: High demand for effective treatments for cancer-related pain, with millions of patients suffering globally [10] - **Study Results**: - 51% of patients treated with Halneuron® showed a 30% reduction in pain, and a 50% reduction in opioid use [11] - Placebo response rate was 35%, indicating Halneuron®'s effectiveness [11] - Durable effect observed, with patients experiencing pain relief for an average of 58 days post-treatment compared to one week for placebo [12] - **Current Phase 2b Study**: - 200 patients, assessing Halneuron® administered once daily over two weeks [14] - Primary endpoint assessed 30 days after the first dose [14] - Interim results expected by December 2025, with final results projected for mid-2026 [18][19] Regulatory Strategy - **FDA Interaction**: The company has established a good relationship with the FDA, aiming for a collaborative approach to drug approval [24] - **Fast-Track Designation**: Halneuron® has received fast-track review designation from the FDA due to its novel approach and high unmet medical need [15] Intellectual Property (IP) and Commercial Strategy - **Current IP**: Based on the unique process of collecting tetrodotoxin from pufferfish, with plans to file new IP for a synthetic formulation [29] - **Commercialization Strategy**: The company is open to partnerships but prioritizes data-driven decisions for maximizing shareholder value [30][31] Financial Position - **Cash Position**: Approximately $13.5 million on hand, sufficient to fund operations through Q1 of the following year [32] - **Burn Rate**: Low operational costs due to a small team of about 12-13 employees [32] Future Outlook - **Next Steps**: If phase 2b is successful, the company plans to initiate a phase 3 program in early 2027 and explore broader cancer-related pain studies [25][26] - **Potential Market**: With 20 million new cancer cases annually, the commercial opportunity for Halneuron® is significant [16] Additional Insights - **Team Experience**: The management team has a strong background in pain drug development, having successfully brought multiple pain medications to market [4][30] - **Synthetic Formulation**: Development of a synthetic version of tetrodotoxin is expected to improve yield, reduce costs, and enhance regulatory acceptance [21]

Company Overview - Dogwood Therapeutics, Inc. is a development-stage biotechnology company focused on creating new medicines for pain and fatigue-related disorders [3] - The company is publicly traded on Nasdaq under the ticker DWTX [3] Upcoming Events - Dogwood Therapeutics will participate in the H.C. Wainwright 27th Annual Global Investment Conference from September 8 to 10, 2025 [1] - CEO Greg Duncan will engage in a fireside chat with Sean Lee, VP of Equity Research at H.C. Wainwright on September 5, 2025, with the presentation available on-demand [2] Research and Development - The company has a research pipeline that includes a non-opioid analgesic program and an antiviral program [3] - The lead candidate in the analgesic program is Halneuron, which targets voltage-gated sodium channels to reduce pain transmission, showing efficacy in treating cancer-related pain and chronic chemotherapy-induced neuropathic pain [3] - Interim data from the ongoing Phase 2 study of Halneuron for chronic chemotherapy-induced neuropathic pain is expected in Q4 2025 [3] Antiviral Program - Dogwood's antiviral program includes IMC-1 and IMC-2, which are fixed-dose combinations of anti-herpes antivirals and the anti-inflammatory agent celecoxib [4] - IMC-1 is advancing towards Phase 3 development for fibromyalgia, while IMC-2 has shown success in reducing fatigue associated with Long-COVID in clinical trials [4] - The company has reached an agreement with the FDA to use fatigue reduction as the primary endpoint for future IMC-2 research related to Long-COVID [4]

Part I: Financial Information [Item 1. Consolidated Financial Statements](index=3&type=section&id=Item%201.%20Consolidated%20Financial%20Statements) This section presents Dogwood Therapeutics' unaudited condensed consolidated financial statements for the periods ended June 30, 2025 [Condensed Consolidated Balance Sheets](index=3&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) Total assets increased to **$96.7 million**, liabilities decreased to **$14.2 million**, and stockholders' equity turned positive to **$6.9 million** as of June 30, 2025 Condensed Consolidated Balance Sheet Highlights (Unaudited) | Metric | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | **Total Assets** | **$96,692,527** | **$94,308,246** | | Cash | $13,402,809 | $14,847,949 | | Goodwill | $12,458,383 | $11,812,476 | | Intangible assets | $69,303,582 | $65,710,527 | | **Total Liabilities** | **$14,151,904** | **$30,027,223** | | Debt with related party | $0 | $15,381,077 | | **Total stockholders' equity (deficit)** | **$6,878,599** | **($10,124,339)** | [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=4&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) The company reported no revenue, with net loss increasing to **$14.7 million** for the six months ended June 30, 2025, driven by a **$6.1 million** debt conversion loss and higher R&D expenses Statement of Operations Highlights (Unaudited, Six Months Ended June 30) | Metric | 2025 | 2024 | | :--- | :--- | :--- | | Revenue | $0 | $0 | | Research and development expenses | $5,006,941 | $679,801 | | General and administrative expenses | $3,346,100 | $1,704,124 | | Loss from operations | ($8,353,041) | ($2,383,925) | | Loss on debt conversion with related party | ($6,134,120) | $0 | | **Net loss** | **($14,732,305)** | **($2,341,168)** | | Net loss per common share, basic and diluted | ($9.51) | ($2.78) | [Condensed Consolidated Statements of Cash Flows](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Net cash used in operating activities increased to **$8.7 million**, while financing activities provided **$7.3 million**, resulting in a **$1.5 million** net decrease in cash for the six months ended June 30, 2025 Cash Flow Summary (Unaudited, Six Months Ended June 30) | Metric | 2025 | 2024 | | :--- | :--- | :--- | | 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, beginning of period | $14,847,949 | $3,316,946 | | Cash, end of period | $13,402,809 | $3,020,183 | - Non-cash financing activities for the six months ended June 30, 2025, included the conversion of **$19.5 million** in related-party debt and **$0.4 million** in accrued interest into Series A-1 Non-Voting Convertible Preferred Stock[15](index=15&type=chunk) [Notes to Condensed Consolidated Financial Statements](index=7&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) The notes detail the company's business focus, going concern issues, the Pharmagesic acquisition, debt conversion, and recent equity financing activities - The company is a pre-revenue, development-stage biopharmaceutical firm focused on two main areas: Nav 1.7 modulation for pain (lead candidate Halneuron®) and antiviral therapies for fatigue-related illnesses (IMC-1, IMC-2)[18](index=18&type=chunk) - Management has concluded there is substantial doubt about the Company's ability to operate as a going concern within one year, as current cash is insufficient to fund operations beyond the first quarter of 2026. Additional financing is required[23](index=23&type=chunk) - On October 7, 2024, the company acquired Pharmagesic (Holdings) Inc. in a business combination, which was accounted for using the acquisition method. This transaction brought in the Halneuron® program[17](index=17&type=chunk)[58](index=58&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=26&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the company's financial condition, operations, and liquidity, highlighting increased expenses from clinical trials and the need for additional financing due to going concern issues [Overview](index=27&type=section&id=Overview) The company focuses on developing pain and fatigue medicines, with lead candidate Halneuron® in a Phase 2b trial and antiviral programs seeking partnerships - The lead product candidate, Halneuron®, is in a Phase 2b clinical trial (HALT-CINP-203) for chemotherapy-induced neuropathic pain (CINP)[125](index=125&type=chunk) - An interim analysis of the HALT-CINP-203 trial is expected in the fourth quarter of 2025, with top-line data anticipated in the second half of 2026[126](index=126&type=chunk) - The antiviral programs for IMC-1 (fibromyalgia) and IMC-2 (Long-COVID) are secondary priorities, and the company is seeking partnerships to advance them[127](index=127&type=chunk)[130](index=130&type=chunk) [Results of Operations](index=29&type=section&id=Results%20of%20Operations) Operating expenses significantly increased for the six months ended June 30, 2025, driven by a **$4.3 million** rise in R&D and a **$1.6 million** increase in G&A expenses Comparison of Operating Expenses (Six Months Ended June 30) | Expense Category | 2025 | 2024 | Change | | :--- | :--- | :--- | :--- | | Research and development | $5,006,941 | $679,801 | +$4,327,140 | | General and administrative | $3,346,100 | $1,704,124 | +$1,641,976 | | **Total operating expenses** | **$8,353,041** | **$2,383,925** | **+$5,969,116** | [Liquidity and Capital Resources](index=29&type=section&id=Liquidity%20and%20Capital%20Resources) With **$13.4 million** cash as of June 30, 2025, the company's liquidity is limited to Q1 2026, necessitating additional financing due to going concern issues - The company's cash on hand of approximately **$13.4 million** as of June 30, 2025, is expected to fund operations only through the first quarter of 2026[138](index=138&type=chunk)[143](index=143&type=chunk) - A registered direct offering in March 2025 raised net proceeds of approximately **$4.25 million**[141](index=141&type=chunk) - Substantial doubt exists regarding the company's ability to continue as a going concern, and it will need to raise additional funds through equity, debt, or partnerships to continue its strategy[143](index=143&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) As a smaller reporting company, Dogwood Therapeutics is not required to provide market risk disclosures - 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 as of June 30, 2025, with no material changes in internal control over financial reporting - Based on an evaluation, the Chief Executive Officer and Chief Financial Officer concluded that the company's disclosure controls and procedures were effective as of June 30, 2025[156](index=156&type=chunk) - There were no changes in internal control over financial reporting during the quarter that materially affected, or are reasonably likely to materially affect, these controls[157](index=157&type=chunk) Part II: Other Information [Item 1. Legal Proceedings](index=33&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently a party to any material pending or ongoing litigation - The company does not currently have any pending or ongoing material litigation[160](index=160&type=chunk) [Item 1A. Risk Factors](index=33&type=section&id=Item%201A.%20Risk%20Factors) No material changes from previously disclosed risk factors in the 2024 Annual Report on Form 10-K are reported - No material changes from risk factors previously disclosed in the 2024 Annual Report on Form 10-K are reported[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) The company reports no unregistered sales of equity securities during the period - None[162](index=162&type=chunk) [Item 5. Other Information](index=33&type=section&id=Item%205.%20Other%20Information) No director or officer adopted or terminated any Rule 10b5-1 trading arrangements during the six months ended June 30, 2025 - No director or officer adopted or terminated any 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 refers to the Exhibit Index, listing all exhibits filed with or incorporated by reference into this Quarterly Report on Form 10-Q