- Low early termination rate (4.3%) among the first 116 patients completing the study suggests Halneuron® treatment to be well tolerated - ATLANTA, Feb. 02, 2026 (GLOBE NEWSWIRE) -- Dogwood Therapeutics, Inc. (Nasdaq: DWTX) (the “Company”), a development-stage biotechnology company developing new medicines to treat pain and neuropathy, today announced it has achieved over 50% of the planned enrollment in its ongoing HAL-CINP-203 Phase 2b chemotherapy induced neuropathic pain (“HALT-CINP”) trial. HALT-CINP ...

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].