Clinical Trials - Enrollment of 100 patients in the ongoing Halneuron® Phase 2b trial, with 80 patients completing treatment, and interim analysis expected in Q4 2025[1][2] - Halneuron® has received fast track designation from the FDA for the treatment of chemotherapy-induced neuropathic pain (CINP)[7] - The forthcoming SP16 IV Phase 1b trial is fully funded by the National Cancer Institute and will commence after FDA consultation[8] Financial Performance - Net loss attributable to common stockholders for Q3 2025 was $15.7 million, or $8.20 per share, compared to a net loss of $2.3 million, or $2.05 per share, in Q3 2024[5] - Research and development expenses for Q3 2025 were $14.5 million, a significant increase from $0.5 million in Q3 2024, primarily due to $12.0 million in acquired in-process R&D expenses related to SP16[3] - General and administrative expenses decreased to $1.3 million in Q3 2025 from $1.8 million in Q3 2024, mainly due to reduced legal and accounting fees[4] Assets and Liabilities - Cash on hand as of September 30, 2025, was $10.1 million, providing operational runway through Q1 2026[5] - Total assets as of September 30, 2025, were $91.99 million, down from $94.31 million at the end of 2024[16] - Total liabilities decreased to $14.61 million as of September 30, 2025, from $30.03 million at the end of 2024[16] Licensing and Partnerships - The company secured an exclusive worldwide, royalty-free license to develop and commercialize SP16 for cancer-related pain[1]

Core Viewpoint - Dogwood Therapeutics, Inc. is advancing its clinical trials and expanding its pipeline with a focus on pain management and neuropathy, reporting significant financial results for Q3 2025, including a notable increase in research and development expenses due to new initiatives and partnerships [2][3][5]. Financial Performance - Research and development expenses for Q3 2025 were $14.5 million, a substantial increase from $0.5 million in Q3 2024, primarily due to $12.0 million in acquired in-process research and development expenses related to the licensing of SP16 and increased clinical trial costs [3]. - General and administrative expenses decreased to $1.3 million in Q3 2025 from $1.8 million in Q3 2024, attributed to lower legal and accounting fees [4]. - The net loss attributable to common stockholders for Q3 2025 was $15.7 million, or $8.20 per share, compared to a net loss of $2.3 million, or $2.05 per share, in Q3 2024 [5]. Clinical Development - The company has enrolled 100 patients in the ongoing Halneuron Phase 2b trial, with 80 patients completing treatment, and plans to release an interim analysis in Q4 2025 [9]. - Halneuron is a non-opioid analgesic in Phase 2b development for chemotherapy-induced neuropathic pain, having received fast track designation from the FDA [7]. - SP16, a new pipeline asset, is a first-in-class candidate aimed at treating cancer-related pain and is fully funded for its Phase 1b study by the National Cancer Institute [2][10]. Pipeline Overview - The research pipeline includes two first-in-class candidates: Halneuron and SP16 IV, targeting pain and neuropathic disorders [6]. - SP16 IV acts as an LRP1 agonist, showing potential for anti-inflammatory effects and nerve damage repair in preclinical studies [8].

Core Viewpoint - Dogwood Therapeutics, Inc. is set to report its third quarter 2025 financial results on November 6, 2025, before the market opens [1] Company Overview - Dogwood Therapeutics is a development-stage biotechnology company focused on creating new medicines for pain and neuropathic disorders [1]

Core Insights - Dogwood Therapeutics, Inc. is a development-stage biotechnology company focused on creating new medicines for pain and neuropathic disorders [1] Company Participation - The CEO, Greg Duncan, will participate in the Maxim Growth Summit organized by Maxim Group LLC [1] - The Summit is scheduled for October 22 - 23, 2025, at the Hard Rock Hotel in New York City [1]

Core Insights - Dogwood Therapeutics, Inc. is a development-stage biotechnology company focused on creating new medicines for pain management [1] - The Chief Medical Officer will present the Halneuron® pain management research program at the 19th Annual Pain Therapeutics Summit on October 14, 2025 [1] - Halneuron® is a highly purified version of tetrodotoxin aimed at treating Chemotherapy Induced Neuropathic Pain (CINP) [1] Company Overview - Dogwood Therapeutics is engaged in the development of innovative treatments for pain, specifically targeting conditions arising from chemotherapy [1] - The company is in the development stage, indicating ongoing research and potential future product offerings [1] Research Program Details - The Halneuron® program focuses on addressing peripheral neuropathic pain that occurs after chemotherapy with certain agents [1] - The presentation at the Pain Therapeutics Summit will provide insights into the research and development progress of Halneuron® [1]

Core Viewpoint - Premarket trading is showing notable activity with significant price movements indicating potential investment opportunities before the market opens [1] Premarket Gainers - Concorde International Group Ltd. (CIGL) increased by 53% to $3.94 [3] - Fermi Inc. Common Stock (FRMI) rose by 13% to $36.99 [3] - Kodiak AI, Inc. (KDK) also saw a 13% increase, reaching $6.76 [3] - AngioDynamics, Inc. (ANGO) gained 12%, trading at $12.45 [3] - Angel Studios, Inc. (ANGX) was up 11% at $8.51 [3] - Spruce Biosciences, Inc. (SPRB) increased by 9% to $9.75 [3] - K Wave Media Ltd. (KWM) rose by 9% to $2.66 [3] - Shoals Technologies Group, Inc. (SHLS) saw an 8% increase, trading at $8.59 [3] - StableX Technologies, Inc. (SBLX) was up 7% at $5.65 [3] Premarket Losers - Uni-Fuels Holdings Limited (UFG) decreased by 51% to $2.42 [4] - Akanda Corp. (AKAN) fell by 13% to $2.91 [4] - Equifax Inc. (EFX) dropped 11%, trading at $224.57 [4] - TransUnion (TRU) also saw an 11% decline, reaching $73.24 [4] - Bolt Biotherapeutics, Inc. (BOLT) decreased by 11% to $4.99 [4] - Dogwood Therapeutics, Inc. (DWTX) fell by 8% to $6.50 [4] - Galaxy Payroll Group Limited (GLXG) decreased by 8% to $4.52 [4] - Old Market Capital Corporation (OMCC) dropped 7% to $5.08 [4] - Entero Therapeutics, Inc. (ENTO) fell by 7% to $3.96 [4] - Flux Power Holdings, Inc. (FLUX) decreased by 7% to $3.74 [4]

Core Insights - Dogwood Therapeutics is committed to improving the lives of cancer patients suffering from chemotherapy-induced peripheral neuropathy, a condition lacking FDA-approved treatments [2][3] Company Developments - The company has secured a global license to develop and commercialize SP16, a first-in-class LRP1 agonist, which will complement its lead compound, Halneuron [3][4] - SP16 is administered intravenously and has shown a dual mechanism of action in preclinical research, indicating potential benefits for patients with chemotherapy-induced neuropathy [3][4] Mechanism of Action - SP16 exhibits both anti-inflammatory and analgesic effects, along with enhanced protein signaling linked to cell survival, growth, and proliferation [4] - The potential use of SP16 alongside Halneuron aims to treat chemotherapy-induced peripheral neuropathy and may also help prevent or repair damage from chemotherapy's off-target effects [4]

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]

Core Insights - Dogwood Therapeutics has secured a royalty-free global license for Serpin Pharma's intravenous formulation of SP16 to manage cancer-related pain, particularly chemotherapy-induced neuropathy [2][3] - SP16 is a first-in-class LRP1 agonist that has shown both anti-inflammatory and neural repair activity, with a Phase 1b study fully funded by the National Cancer Institute set to begin patient enrollment in the first half of 2026 [1][3] - The licensing agreement includes the issuance of shares representing 7.31% of Dogwood's common stock on a fully diluted basis [10] Company Developments - The CEO of Dogwood Therapeutics emphasized that the SP16 in-license aligns with the company's strategic objective to expand its research pipeline in pain and neuropathy management [4] - Halneuron, Dogwood's lead product candidate, is currently in Phase 2b development for treating chemotherapy-induced neuropathic pain and has received fast-track designation from the FDA [7][13] - Interim data from the ongoing Halneuron Phase 2b study is expected in December 2025, with over eighty patients already recruited [7][14] Research and Clinical Insights - SP16 IV mimics the anti-inflammatory and immunomodulatory actions of alpha-1-antitrypsin, showing promise in addressing symptoms and damage associated with chemotherapy-induced peripheral neuropathy [4][8] - The combination of SP16 with Halneuron may provide adjunctive improvement for non-pain symptoms related to cancer treatment [6] - The unique approach of SP16 reflects the significant unmet medical need in managing cancer-related pain and neuropathy [3][4]