Dogwood Announces Completion of Enrollment in Ongoing Halneuron® Phase 2b Trial

Dogwood fully enrolls its Phase 2b Halneuron trial in CINP, setting up a November 2026 efficacy and safety readout.

Rhea-AI Summary

Dogwood Therapeutics (DWTX) has completed enrollment of 239 patients in its ongoing Phase 2b HAL-CINP trial of Halneuron® for chemotherapy induced neuropathic pain, reaching the upper end of its planned enrollment range, with topline data expected in November 2026.

The company states that positive results would be a major milestone for patients with CINP, which currently has no FDA-approved treatments. HAL-CINP (NCT06848348) is a randomized Phase 2b study at about 25 U.S. sites comparing Halneuron® with placebo in patients with moderate to severe neuropathic pain caused by prior platinum and/or taxane-based chemotherapy. Participants receive eight subcutaneous doses over 14 days and are followed for 28 days. The primary endpoint is change from baseline to week four in the weekly average of daily 24-hour recall pain intensity scores, with secondary measures assessing effects on sleep, fatigue, neuropathy symptoms and overall health.

Positive

• Phase 2b HAL-CINP trial fully enrolled with 239 patients at upper target range
• Topline Phase 2b data for Halneuron® in CINP expected in November 2026
• Trial includes approximately 25 U.S. sites, supporting a broader clinical data set

Negative

• None.

Market Context

A prior same-trial enrollment update recorded a 0% 24-hour price reaction; it established earlier pr...

Analysis

A prior same-trial enrollment update recorded a 0% 24-hour price reaction; it established earlier program progress before this completion announcement, providing historical context for the newly disclosed enrollment milestone.

Key Figures

Enrollment: 239 patients Topline data timing: November 2026 Doses: 8 subcutaneous doses +2 more

Enrollment

239 patients

Halneuron Phase 2b CINP trial

Topline data timing

November 2026

Expected Phase 2b readout

Doses

8 subcutaneous doses

Administered over 14 days

Follow-up period

28 days

Total safety and effectiveness follow-up

Study sites

Approximately 25 sites

U.S. trial sites

Historical Context

1 past event · Latest: Jul 20

1 event

1. Jul 20

   Phase 2b enrollment

   24h Move

   +0.0%

   Reported first 200 patients enrolled in the same ongoing Halneuron Phase 2b trial.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Key Terms

phase 2b, topline data, placebo, primary endpoint, +1 more

5 terms

phase 2b medical

"completion of patient enrollment in its ongoing Halneuron Phase 2b"

Phase 2b is a stage in the development of a new medicine or treatment where researchers test its effectiveness and safety in a larger group of people. This step helps determine whether the treatment works well enough to move forward and if it has manageable side effects, which is important for investors because successful results can lead to potential approval and market opportunity.

topline data technical

"anticipates topline data readout of the study in November 2026"

Topline data are the initial, high-level results from a clinical study that show whether the main goals of the trial were met, much like the headline of a news story that summarizes the most important point. Investors care because these early outcomes quickly indicate a drug’s commercial potential and regulatory path — positive topline results can boost a company’s value, while disappointing ones can sharply reduce expected future revenue.

placebo medical

"evaluating the efficacy and safety of Halneuron compared with placebo"

A placebo is an inactive pill, injection or procedure that looks and feels like the real treatment but contains no therapeutic ingredient, often called a sugar pill. Investors care because comparing a drug to a placebo reveals whether observed benefits come from the medicine itself or from expectation; clear superiority over placebo reduces regulatory and commercial risk, much like a blind taste test proves a new recipe really tastes better.

primary endpoint medical

"The primary endpoint for this study is the change from baseline"

The primary endpoint is the single main result a clinical study is designed to measure to decide if a treatment works, like the finish line in a race that tells you who won. Investors care because meeting or missing this goal drives regulatory decisions, future sales expectations and stock value — it turns trial data into a clear yes-or-no signal about a drug’s commercial prospects.

subcutaneous medical

"Participants receive 8 subcutaneous doses of Halneuron"

Subcutaneous means situated or applied just beneath the skin. In finance, the term can describe processes or investments that are hidden or not immediately visible, much like something placed under the skin that isn't easily seen from the outside. Recognizing subcutaneous activities helps investors understand underlying factors that may influence markets or asset values over time.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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- Enrollment of 239 Patients Meets Upper End of Planned Enrollment Target Range -

- Topline Data Expected in November 2026 -

ATLANTA, Sept. 14, 2026 (GLOBE NEWSWIRE) -- Dogwood Therapeutics, Inc. (Nasdaq: DWTX) (“Dogwood” or the “Company”), a company that focuses on developing first-in-class, new non-opioid medicines to treat pain and neuropathy, today announced the completion of patient enrollment in its ongoing Halneuron^® Phase 2b Chemotherapy Induced Neuropathic Pain (“CINP”) trial. The Company anticipates topline data readout of the study in November 2026. Positive results from this study, if achieved, would represent a significant milestone for the Company, as well as for patients suffering from CINP, a condition for which there are no FDA approved treatments.

“Health care provider and CINP patient interest in participating in our HAL-CINP Phase 2b CINP trial was very high, which led us to recruit to the top of our projected target range,” said Greg Duncan, Chief Executive Officer of Dogwood Therapeutics. “Based on our encouraging interim analysis, we remain confident that Halneuron^® treatment can demonstrate pain improvement when compared with placebo treated patients when Phase 2b topline data are reported this November.“

Halneuron^® CINP Phase 2b Trial (“HAL-CINP”) Overview (NCT06848348)

HAL-CINP is a randomized, phase 2b clinical trial evaluating the efficacy and safety of Halneuron^® compared with placebo in 239 patients with moderate to severe neuropathic pain caused by prior platinum and/or taxane-based chemotherapy. Participants receive 8 subcutaneous doses of Halneuron^® or placebo over a 14-day period and are followed for a total of 28 days for safety and effectiveness. The primary endpoint for this study is the change from baseline to week four in the weekly average of daily 24-hour recall pain intensity scores. The study is being conducted at approximately 25 sites in the U.S. Secondary measures will assess Halneuron’s^® treatment effects on sleep, fatigue, neuropathy symptoms and overall patient health.

About Dogwood Therapeutics

Dogwood Therapeutics (Nasdaq: DWTX) is a development-stage biopharmaceutical company focused on developing first-in-class, non-opioid medicines to treat pain and neuropathic disorders. The Dogwood research pipeline includes two first-in-class development candidates, Halneuron^® and SP16 IV.

Our lead product candidate, Halneuron^®, is in Phase 2b development to treat pain conditions including the neuropathic pain associated with chemotherapy treatment. Halneuron® has been granted fast track designation from the FDA for the treatment of CINP. Halneuron^® is a non-opioid, Na_V 1.7 analgesic which is a highly specific voltage-gated sodium channel modulator, a mechanism known to be effective for reducing pain transmission. In clinical studies, Halneuron^® treatment has demonstrated pain reduction in pain related to general cancer and in pain related to chronic chemotherapy-induced neuropathic pain CINP. SP16 IV is a low-density lipoprotein receptor related protein-1 agonist (“LRP1”) with potential to treat neuropathy and prevent or repair nerve damage following chemotherapy. SP16’s activity as an LRP1 agonist in turn provides alpha-1-antitrypsin-like activity. Consistent with alpha-1-antitrypsin anti-inflammatory and immunomodulatory actions, SP16 preclinically demonstrated anti-inflammatory (analgesic) action via potential reductions in IL-6, IL-8, IL1B and TNF-alpha levels, as well as potential to repair damaged tissue via increases in pAKT and pERK that regulate fundamental processes like growth, proliferation and survival. The forthcoming SP16 IV Phase 1b CIPN trial is fully funded by the National Cancer Institute.

Dogwood Therapeutics’ largest shareholder is a member of CK Life Sciences Int’l., (Holdings) Inc., which is listed on the Hong Kong Stock Exchange (Stock code: 0775). For more information, please visit www.dwtx.com.

Forward-Looking Statements:

Statements in this press release contain “forward-looking statements,” within the meaning of the U.S. Private Securities Litigation Reform Act of 1995, that are subject to substantial risks and uncertainties. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as “anticipate,” “believe,” “contemplate,” “could,” “estimate,” “expect,” “intend,” “seek,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “suggest,” “target,” “aim,” “should,” "will,” “would,” or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on Dogwood’s current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict, including risks related to the completion, timing, enrollment, design and results of current and future clinical studies relating to Dogwood’s product candidates; whether interim or final clinical data will support continued development, regulatory submissions or approval; and Dogwood’s ability to finance its operations. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. These and other risks and uncertainties are described more fully in the section titled “Risk Factors” in the most recently filed Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission. Forward-looking statements contained in this announcement are made as of this date, and Dogwood undertakes no duty to update such information except as required under applicable law.

Investor Relations:

Dan Ferry
Managing Director
LifeSci Advisors, LLC
daniel@lifesciadvisors.com

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What condition is Halneuron® being evaluated for in the HAL-CINP Phase 2b trial?

Halneuron® is being evaluated for chemotherapy induced neuropathic pain (CINP) in patients who developed moderate to severe neuropathic pain after prior platinum and/or taxane-based chemotherapy. The company notes that there are currently no FDA-approved treatments specifically for CINP.

How is the HAL-CINP Phase 2b trial for Halneuron® designed?

HAL-CINP is a randomized Phase 2b trial comparing Halneuron® versus placebo in 239 patients with moderate to severe CINP. Participants receive eight subcutaneous doses of Halneuron® or placebo over a 14-day period and are followed for a total of 28 days to assess safety and effectiveness.

What is the primary efficacy endpoint in the HAL-CINP Phase 2b study?

The primary endpoint is the change from baseline to week four in the weekly average of daily 24-hour recall pain intensity scores, which measures how patients’ reported pain levels evolve over the treatment period.

What secondary outcomes are being measured in the HAL-CINP trial?

Secondary measures will assess Halneuron’s® treatment effects on sleep, fatigue, neuropathy symptoms, and overall patient health, providing additional information on broader patient-reported outcomes beyond pain intensity.