Core Insights - Dogwood Therapeutics has achieved over 50% enrollment in its HALT-CINP Phase 2b trial for chemotherapy-induced neuropathic pain, with top line results expected in Q3 2026 [1][4] - The low early termination rate of 4.3% among the first 116 patients indicates that the Halneuron treatment is well tolerated [1][2] - If successful, Halneuron could become the first approved therapy for chemotherapy-induced neuropathic pain, addressing a significant unmet medical need [2] Enrollment and Study Design - The HALT-CINP trial is designed to provide over 80% statistical power to detect treatment differences between Halneuron and placebo upon unblinding in Q3 2026 [3] - The trial involves 8 subcutaneous doses of Halneuron or placebo over 14 days, with a total follow-up of 28 days to assess safety and effectiveness [4] Interim Results - An interim analysis of 97 patients showed that those treated with Halneuron demonstrated significant pain improvement compared to placebo, with an average duration of chemotherapy-induced neuropathic pain of 5 years [2] - The overall dropout rate of approximately 4.0% is significantly lower than typical rates observed in studies of other FDA-approved chronic pain medications [2] Company Overview - Dogwood Therapeutics is focused on developing new medicines for pain and neuropathic disorders, with Halneuron as its lead product candidate currently in Phase 2b development [5] - Halneuron has received fast track designation from the FDA for treating chemotherapy-induced neuropathic pain and is a non-opioid analgesic targeting voltage-gated sodium channels [5] Future Developments - The company is also developing SP16 IV, which has potential applications in treating neuropathy and repairing nerve damage following chemotherapy, with funding from the National Cancer Institute for its upcoming Phase 1b trial [5]

Core Viewpoint - Dogwood Therapeutics, Inc. has entered into a securities purchase agreement for up to approximately $12.5 million in gross proceeds through a registered direct offering and a concurrent private placement, aimed at advancing the development of its non-opioid medicines for pain and neuropathy treatment [1][3] Group 1: Offerings Details - The offerings consist of the issuance of 4,386,037 shares of common stock and warrants to purchase an equal number of shares, priced at $2.85 per share [1][2] - The registered offering includes 2,338,948 shares of common stock, while the private offering includes pre-funded warrants for 2,047,089 shares and warrants for 4,386,037 shares [2] Group 2: Use of Proceeds - The net proceeds from the offerings will be utilized to advance the clinical development of Halneuron® and for working capital and general corporate purposes [3][4] - The company aims to support the ongoing Phase 2b final data readout for Halneuron® and pursue strategic opportunities to enhance its research portfolio [3] Group 3: Company Overview - Dogwood Therapeutics is focused on developing new non-opioid medicines for pain and neuropathic disorders, with its lead product candidate Halneuron® currently in Phase 2b development for chemotherapy-induced neuropathic pain [8] - Halneuron® has received fast track designation from the FDA, and the company also has another candidate, SP16 IV, which is set to enter a Phase 1b trial funded by the National Cancer Institute [8]

Core Viewpoint - Changjiang Life Sciences Technology (0775.HK) announced positive interim results from the ongoing Phase 2b study of Halneuron for chemotherapy-induced neuropathic pain (CINP) conducted by its biopharmaceutical subsidiary Dogwood Therapeutics (DWTX.US) [1] Group 1 - The independent statistical review committee analyzed data from 97 patients who completed treatment and found a positive difference in pain improvement between patients receiving Halneuron and those receiving a placebo [1] - The current recruitment trend for the Phase 2b trial is expected to provide approximately 80% to 85% statistical power to detect differences in Halneuron treatment [1] - Dogwood anticipates obtaining preliminary results by the third quarter of 2026 based on the current recruitment pace and interim assessment results [1] Group 2 - The results of the independent interim analysis have strengthened the company's confidence that Halneuron could provide a treatment option for CINP patients, where standard therapies are currently lacking [1] - The analysis supports the strategic vision of the group to develop pain and related condition medications through Dogwood [1]

Group 1 - The core announcement is regarding the positive interim results from the ongoing Phase 2b study of Halneuron for chemotherapy-induced neuropathic pain (CINP) conducted by Dogwood Therapeutics, Inc. [1] - The study involved 97 patients who completed treatment, showing a significant difference in pain improvement between those receiving Halneuron and those on placebo [1]. - The average duration of CINP among the study participants was 5 years, with 67% of patients concurrently on stable doses of other chronic pain medications [2]. Group 2 - The overall dropout rate for the study was approximately 4.4%, which is significantly lower than the dropout rates of other FDA-approved chronic pain medications [2]. - Dogwood anticipates obtaining preliminary results by Q3 2026, based on the current recruitment pace and interim analysis results, with an expected statistical power of 80% to 85% to detect treatment differences [2]. - Dogwood is a development-stage biopharmaceutical company focused on developing new drugs for pain relief and neuropathic symptoms, holding approximately 83% indirect equity interest in Dogwood [2].

Group 1 - The core announcement is regarding the positive interim results from the ongoing Phase 2b study of Halneuron for chemotherapy-induced neuropathic pain (CINP) conducted by Dogwood Therapeutics, Inc. [1] - The study involved 97 patients who completed treatment, showing a significant difference in pain improvement between those receiving Halneuron and those on placebo [1] - Dogwood emphasizes that the preliminary evidence of Halneuron's effectiveness is noteworthy, especially considering that 67% of the patients were concurrently on stable doses of other chronic pain medications [2] Group 2 - The overall dropout rate for the study was approximately 4.4%, which is significantly lower than the dropout rates of other FDA-approved chronic pain medications [2] - Despite being in a blinded phase, Dogwood believes the findings reaffirm the encouraging safety and tolerability observed in previous clinical trials of Halneuron [2] - The company anticipates obtaining preliminary results by Q3 2026, with the current study expected to provide about 80% to 85% statistical power to detect treatment differences [2] Group 3 - Dogwood Therapeutics is a development-stage biopharmaceutical company registered in Delaware and listed on the NASDAQ under the ticker DWTX, focusing on developing new drugs for alleviating pain and neurological discomfort [2] - The company currently holds approximately 83% indirect equity interest in Dogwood [2]

Core Insights - Changjiang Life Sciences Technology (00775.HK) announced the latest developments regarding its investment in Dogwood Therapeutics, Inc. (DWTX), a biopharmaceutical company focused on developing new drugs for pain relief and neuropathic symptoms, holding approximately 83% indirect equity in Dogwood [1] Group 1: Clinical Trial Results - Dogwood reported positive mid-term analysis results from its ongoing Phase 2b study of Halneuron® for chemotherapy-induced neuropathic pain (CINP), with 97 patients completing treatment [1] - The independent statistical review committee found a significant difference in pain improvement between patients treated with Halneuron® and those receiving a placebo during the four-week study [1] Group 2: Patient Demographics and Treatment Context - The average duration of CINP among patients in the mid-term analysis was 5 years, with 67% of eligible patients concurrently receiving stable doses of other chronic pain medications, including pregabalin, gabapentin, duloxetine, and opioids [2] - The overall dropout rate for the study was approximately 4.4%, significantly lower than the dropout rates of other FDA-approved chronic pain medications [2] Group 3: Future Expectations - Dogwood anticipates obtaining preliminary results from the Phase 2b trial by the third quarter of 2026, based on current recruitment speed and mid-term evaluation results [2] - The ongoing study is expected to provide approximately 80% to 85% statistical power to detect treatment differences for Halneuron® [2]

Core Insights - Dogwood Therapeutics, Inc. announced positive interim results from its Phase 2b study of Halneuron for chemotherapy-induced neuropathic pain (CINP), showing significant pain improvement compared to placebo [1][3] - The company expects to release top-line results in Q3 2026, with current enrollment trends indicating a statistical power of approximately 80% to 85% [2] - Halneuron is a non-opioid NaV 1.7 inhibitor, which has received fast track designation from the FDA for treating CINP, and aims to provide a new therapeutic option for cancer survivors [4][6] Company Overview - Dogwood Therapeutics is a development-stage biopharmaceutical company focused on creating new medicines for pain and neuropathic disorders, with Halneuron as its lead product candidate [5] - The company also has another candidate, SP16 IV, which targets neuropathy and nerve damage repair following chemotherapy [7] Clinical Study Details - The Phase 2b study involved 97 patients, with a dropout rate of approximately 4.4%, significantly lower than typical rates for FDA-approved chronic pain medications [1][3] - The average duration of CINP among participants was 5 years, with 67% of patients concurrently using other chronic pain medications [3] Future Prospects - Positive outcomes from the ongoing Phase 2b trial could pave the way for a Phase 3 registration program for Halneuron, addressing a significant unmet need in treating moderate-to-severe neuropathic pain post-chemotherapy [4]

Summary of Dogwood Therapeutics Special Meeting Company Overview - **Company**: Dogwood Therapeutics (NasdaqCM:DWTX) - **Event**: 2025 Extraordinary General Meeting - **Date**: November 21, 2025 Key Proposals Discussed 1. **Proposal One**: Approval for the issuance of common stock upon conversion of Series A non-voting convertible preferred stock, par value $0.0001 per share [8] 2. **Proposal Two**: Approval for the issuance of common stock upon conversion of Series A1 non-voting preferred stock, par value $0.0001 per share [9] 3. **Proposal Three**: Approval for the issuance of common stock upon conversion of Series A2 non-voting convertible preferred stock, par value $0.0001 per share [9] 4. **Proposal Four**: Approval of the Dogwood Therapeutics Second Amended and Restated 2020 Equity Incentive Plan [9] 5. **Proposal Five**: Approval for the adjournment of the special meeting to a later date if necessary [9] Voting Results - **Proposal One**: Approved under both Delaware law and NASDAQ Listing Rules [13] - **Proposal Two**: Approved under both Delaware law and NASDAQ Listing Rules [13] - **Proposal Three**: Approved under both Delaware law and NASDAQ Listing Rules [14] - **Proposal Four**: Approved [14] - **Proposal Five**: Approved [14] Additional Information - A quorum was established with more than one-third of the outstanding shares present [6] - The final voting results will be filed with the SEC on Form 8K within four business days after the meeting [16] - The meeting concluded with a focus on improving care for patients suffering from pain and neuropathy [16]

Core Insights - Dogwood Therapeutics, Inc. has successfully enrolled the first 100 patients in its ongoing HALT-CINP Phase 2b CINP trial, indicating progress in its clinical development efforts [1] - The continued low early termination rate among the first 80 study completers suggests that both Halneuron® and placebo treatment have been well tolerated, reflecting positively on the safety profile of the treatments being tested [1] - An interim analysis is scheduled for the fourth quarter of 2025, focusing on patients who have completed or been terminated from the four-week study, which will provide insights into the trial's efficacy and safety [1]

Financial Performance - The company has incurred losses and generated negative cash flows from operations since inception, with cash totaling $10.1 million as of September 30, 2025 [161]. - For the nine months ended September 30, 2025, net cash used in operations was $12.0 million, consisting of a net loss of $30.5 million [168]. - The company experienced a decrease in cash of $4.7 million for the nine months ended September 30, 2025, compared to a decrease of $1.3 million in the same period of 2024 [167]. - The company has substantial doubt regarding its ability to continue as a going concern within 12 months from the issuance of the Quarterly Report [166]. Research and Development - Research and development expenses increased by $14.0 million and $18.3 million for the three and nine months ended September 30, 2025, respectively, compared to prior periods [158]. - The HALT-CINP-203 clinical trial is intended to assess the efficacy and safety of Halneuron® in approximately 200 patients with moderate to severe neuropathic pain [146]. - An interim analysis of data from approximately 40-50% of the patients enrolled in HALT-CINP-203 is expected in the fourth quarter of 2025 [148]. - The company licensed the rights to the IV formulation of SP16 for the treatment of chemotherapy-induced peripheral neuropathy, with initial Phase 1 evaluation expected to start in the first half of 2026 [149]. - Halneuron® has been granted FDA fast-track review designation as a treatment for chemotherapy-induced neuropathic pain (CINP) [147]. Operating Expenses - Total operating expenses for the three months ended September 30, 2025, were $15,809,125, compared to $2,301,172 for the same period in 2024 [157]. - General and administrative expenses decreased by $0.5 million for the three months ended September 30, 2025, compared to prior periods [160]. Financing Activities - The company entered into a Loan Agreement for a principal amount of $19,500,000, with $16,500,000 disbursed on October 7, 2024 [150]. - The company raised approximately $4.78 million through a registered direct offering of 578,950 shares of Common Stock on March 14, 2025 [163]. - The company received $3 million in loan proceeds on February 18, 2025, with no debt outstanding as of September 30, 2025 due to a Debt Exchange and Cancellation Transaction [164]. - Net cash provided by financing activities for the nine months ended September 30, 2025 was $7.3 million, attributed to loan proceeds and gross proceeds from the registered direct offering [170]. Cash Position - As of September 30, 2025, the company anticipates cash on hand of approximately $10.1 million to fund operations through the first quarter of 2026 [166]. - The company reclassified approximately $5.5 million from temporary equity to permanent equity due to waivers by holders of Series A Preferred Stock [174]. - The company will need to secure additional financing to fund ongoing clinical trials and operations beyond the first quarter of 2026 [166]. Off-Balance Sheet Arrangements - The company did not have any off-balance sheet arrangements as of September 30, 2025 [173].