Dogwood Therapeutics Announces Positive Interim Phase 2b Clinical Trial Results in Chemotherapy Induced Neuropathic Pain

Dogwood Therapeutics (Nasdaq: DWTX) reported a positive interim analysis from 97 patients in its Phase 2b study of Halneuron for chemotherapy induced neuropathic pain (CINP) on Dec 22, 2025.

Rhea-AI Summary

Dogwood Therapeutics (Nasdaq: DWTX) reported a positive interim analysis from 97 patients in its Phase 2b study of Halneuron for chemotherapy induced neuropathic pain (CINP) on Dec 22, 2025. An independent committee found Halneuron-treated patients separated from placebo on pain improvement over four weeks. The company projects top-line results in Q3 2026 and enrollment trends that provide ~80%–85% statistical power. The interim cohort had an average CINP duration of 5 years, with 67% on stable background pain meds; overall dropout was ~4.4%. The company says safety and tolerability remain encouraging, and positive Phase 2b outcomes could support a Phase 3 registration program.

Positive

• Interim separation from placebo on four-week pain improvement
• Projected top-line results in Q3 2026
• Study power projected at approximately 80%–85%
• Low overall dropout of approximately 4.4%

Negative

• Interim analysis only; results are not final or peer-reviewed
• 67% of patients on concomitant chronic pain meds could confound effects

Argus Dec 22 session

-24.96% close to close Open Argus

Details

News Market Reaction – DWTX

On Dec 22, the day this news came out, DWTX closed 24.96% below the previous close.

Data tracked by StockTitan Argus for the Dec 22 session.

Key Figures

Interim patients: 97 patients Study duration: 4 weeks Statistical power: 80%–85% +5 more

Interim patients

97 patients

Completed treatment in ongoing Halneuron® Phase 2b CINP study

Study duration

4 weeks

Pain improvement assessment period in Phase 2b trial

Statistical power

80%–85%

Projected power to detect Halneuron® treatment difference

Average CINP duration

5 years

Mean duration of chemotherapy-induced neuropathic pain in interim population

Concomitant therapies

67% of patients

Also on stable chronic pain medicines (e.g., pregabalin, opioids)

Dropout rate

4.4%

Overall study dropout, noted as far below typical chronic pain rates

Top-line timing

Q3 2026

Expected availability of Phase 2b top-line results

Nav 1.7 mechanism

Nav 1.7 sodium channel inhibition

Halneuron® target for treating chronic and acute pain

Historical Context

5 past events · Latest: Dec 02

5 events

1. Dec 02

   IP/exclusivity update

   24h Move

   -2.0%

   Filed new synthetic Halneuron® IP potentially extending exclusivity to 2045.

2. Nov 11

   Trial enrollment

   24h Move

   +1.4%

   Reported first 100 patients enrolled and low early termination in Phase 2b.

3. Nov 06

   Q3 earnings

   24h Move

   -6.5%

   Q3 2025 showed higher R&D, large net loss and per‑share loss.

4. Oct 30

   Earnings date notice

   24h Move

   +7.8%

   Announced timing of Q3 2025 financial results release.

5. Oct 14

   Conference participation

   24h Move

   +1.0%

   Disclosed CEO participation at the Maxim Growth Summit meetings.

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

Key Terms

chemotherapy induced neuropathic pain, Nav 1.7 sodium channel inhibition, placebo, statistically significant trial, +1 more

5 terms

chemotherapy induced neuropathic pain medical

"Phase 2b clinical trial results in chemotherapy induced neuropathic pain"

Chemotherapy induced neuropathic pain is persistent nerve pain and numbness that can follow cancer treatment, felt as burning, tingling, or electric shocks in hands and feet. It matters to investors because it affects patient quality of life, can limit or interrupt cancer therapy, and creates demand for new treatments and supportive care—similar to how a common side effect can change product use and market size for a drug class.

Nav 1.7 sodium channel inhibition medical

"We have long believed that Nav 1.7 sodium channel inhibition holds great promise"

Nav1.7 sodium channel inhibition is the blocking of a specific protein on nerve cells (the Nav1.7 channel) that acts like a gate for electrical signals involved in sensing pain. Drugs that inhibit this gate can reduce or stop pain signals, so they are monitored closely by investors because success in this area could create large markets for non‑opioid pain therapies while failure or safety issues can sharply affect a drug developer’s value.

placebo medical

"Halneuron® treated patients separating from placebo on pain improvement assessment"

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.

statistically significant trial medical

"potential to represent the first statistically significant trial involving CINP patients"

A statistically significant trial is a clinical study whose results show an effect unlikely to have occurred by random chance according to pre-set criteria, meaning the observed difference is probably real rather than noise. For investors, this matters because statistically significant outcomes strengthen confidence that a therapy or intervention works, which can affect regulatory approval prospects, market expectations, and a company’s future revenue — similar to a referee confirming a clear score in a close game.

opioids medical

"other chronic pain medicines, including pregabalin, gabapentin, duloxetine, and opioids"

Opioids are a class of drugs that relieve pain by acting on the nervous system; they include prescription pain medications as well as illegal substances. Investors care because opioids can be a major source of revenue for drug makers and distributors while also creating significant regulatory scrutiny, legal liability, and public-health liabilities — like a bestselling product that can also trigger recalls, fines, and lawsuits that affect a company's value.

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

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- Halneuron^® treated patients separating from placebo on pain improvement assessment; Company expects top-line results availability in Q3 2026 -

- The overall study dropout rate of ~4.4% is far below rates typically observed with other FDA approved chronic pain medicines -

ATLANTA, Dec. 22, 2025 (GLOBE NEWSWIRE) -- Dogwood Therapeutics, Inc. (Nasdaq: DWTX) (the “Company”), a development-stage biotechnology company developing new medicines to treat pain and neuropathy, today announces positive results from an interim analysis of 97 patients who had completed treatment in the ongoing Halneuron^® Phase 2b chemotherapy induced neuropathic pain (“CINP”) study. The independent statistical review committee reviewed unblinded patient treatment data from the Phase 2b trial and concluded that Halneuron^® treated patients are demonstrating separation from placebo treated patients in terms of pain improvement over the four-week study.   

Based on the current Phase 2b trial enrollment pace and the interim assessment results, the Company continues to expect to have top-line results available during Q3 2026. Current study patient enrollment trends are projected to provide statistical power of approximately 80% to 85% to detect a Halneuron^® treatment difference.

“We have long believed that Na_v 1.7 sodium channel inhibition holds great promise for treating both chronic and acute pain,” said Greg Duncan, Dogwood Therapeutics Chief Executive Officer. “Extrapolation of the current Phase 2b study trends has the potential to represent the first statistically significant trial involving CINP patients under FDA chronic pain study guidance.”

This preliminary evidence of a Halneuron^® treatment effect is noteworthy as patients in the interim analysis population present an average duration of CINP of 5 years and 67% of patients that met entry criteria were also being treated with stable doses of other chronic pain medicines, including pregabalin, gabapentin, duloxetine, and opioids. In addition, the overall study dropout rate of approximately 4.4% is far below rates typically observed with other FDA approved chronic pain medicines. While still blinded, the Company believes these findings reaffirm the encouraging safety and tolerability profile of Halneuron^® observed in previous clinical trials.

“There are currently no approved therapies to treat the moderate-to-severe neuropathic pain that occurs following chemotherapy treatment,” said Dr. R. Michael Gendreau, Chief Medical Officer of Dogwood Therapeutics. “We are hopeful that positive outcomes in this ongoing Phase 2b trial will set the stage for a Phase 3 registration program in CINP, providing a needed therapeutic option for this patient population of cancer survivors.”

About Halneuron^®

Our lead product candidate, Halneuron^®, is in Phase 2b development as a non-opioid, Na_V 1.7 inhibitor to treat pain conditions including the neuropathic pain associated with chemotherapy treatment. Halneuron^® has been granted fast track designation from the Food and Drug Administration (“FDA”) for the treatment of CINP. Success in this Phase 2b study will serve as the basis for the Company engaging FDA to align on the Halneuron^® Phase 3 development program requirements.

About Dogwood Therapeutics

Dogwood Therapeutics (Nasdaq: DWTX) is a development-stage biopharmaceutical company focused on developing new 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 acts as an LRP1 agonist that 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 CINP trial is fully funded by the National Cancer Institute.

Dogwood Therapeutic’s 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 and results of current and future clinical studies relating to Dogwood’s product candidates. 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 Annual Report on Form 10-K for the year ended December 31, 2024, 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:

CORE IR
(516) 222-2560
IR@dwtx.com

FAQ

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

What did Dogwood Therapeutics (DWTX) announce on December 22, 2025 about Halneuron Phase 2b?

Dogwood announced a positive interim analysis of 97 patients showing Halneuron separated from placebo on four-week pain improvement.

When does Dogwood expect top-line Halneuron Phase 2b results for DWTX?

The company expects to have top-line Phase 2b results available during Q3 2026.

How much statistical power does Dogwood project for the Halneuron Phase 2b study (DWTX)?

Current enrollment trends are projected to provide approximately 80%–85% statistical power to detect a treatment difference.

How many patients were in the Halneuron interim analysis and what was the dropout rate for DWTX?

The interim analysis included 97 patients and reported an overall study dropout rate of ~4.4%.

What was the clinical profile of patients in Dogwood's Halneuron interim CINP cohort (DWTX)?

Interim patients averaged 5 years of CINP duration and 67% were on stable doses of other chronic pain medicines.

Do Dogwood's interim Phase 2b Halneuron results guarantee approval or Phase 3 initiation for DWTX?

No; the results are preliminary and interim—further data, full analysis, and regulatory discussions would be needed before Phase 3 or approval decisions.