Dogwood Therapeutics Announces 50% Enrollment in Ongoing Halneuron® Phase 2b Trial, Top Line Results Anticipated in Q3 2026

Dogwood Therapeutics (Nasdaq: DWTX) announced it has reached over 50% enrollment in the HALT-CINP Phase 2b trial of Halneuron® for chemotherapy-induced neuropathic pain and remains on track for top-line results in Q3 2026.

Rhea-AI Summary

Dogwood Therapeutics (Nasdaq: DWTX) announced it has reached over 50% enrollment in the HALT-CINP Phase 2b trial of Halneuron® for chemotherapy-induced neuropathic pain and remains on track for top-line results in Q3 2026.

An independent review of an earlier interim cohort reported separation from placebo on pain improvement and a low overall dropout rate (~4%). The randomized trial enrolls at ~30 U.S. sites with a 28-day follow-up and primary endpoint at week four.

Positive

• Enrollment >50% for HALT-CINP Phase 2b
• Top-line results projected in Q3 2026
• Independent interim review showed pain improvement separation from placebo
• Low overall dropout rate of approximately 4.0%
• Study powered >80% to detect treatment difference

Negative

• Interim results are preliminary and not final efficacy evidence
• Final clinical outcome depends on unblinded Phase 2b data in Q3 2026
• Phase 2b limited to ~30 U.S. sites, potentially restricting generalizability

Argus Feb 2 session

+5.02% close to close Open Argus

Details

News Market Reaction – DWTX

On Feb 2, the day this news came out, DWTX closed 5.02% above the previous close.

Data tracked by StockTitan Argus for the Feb 2 session.

Key Figures

Patients completed: 116 patients Early termination rate: 4.3% Study dropout rate: approximately 4.0% +5 more

Patients completed

116 patients

First 116 patients completing HALT-CINP Phase 2b

Early termination rate

4.3%

Among first 116 patients completing HALT-CINP

Study dropout rate

approximately 4.0%

Overall dropout in HALT-CINP Phase 2b

Average pain duration

5 years

Average duration of CINP in interim analysis population

Dosing schedule

8 doses over 14 days

Sub-cutaneous Halneuron® or placebo regimen

Follow-up period

28 days

Total safety and effectiveness follow-up per patient

Statistical power

>80%

Planned power to detect treatment difference at unblinding

Trial sites

approximately 30 sites

HALT-CINP Phase 2b locations in the U.S.

Historical Context

5 past events · Latest: Jan 12

5 events

1. Jan 12

   Financing announcement

   24h Move

   +5.6%

   Financing of up to $26.8M to fund Halneuron® Phase 2b development.

2. Dec 22

   Clinical interim data

   24h Move

   -25.0%

   Positive Phase 2b interim CINP results showing separation from placebo.

3. Dec 02

   IP / exclusivity

   24h Move

   -2.0%

   New synthetic Halneuron® IP filing projected to extend exclusivity to 2045.

4. Nov 11

   Enrollment update

   24h Move

   +1.4%

   First 100 patients enrolled in Phase 2b, with low early termination rates.

5. Nov 06

   Earnings / update

   24h Move

   -6.5%

   Q3 2025 loss of $15.7M and going concern language amid higher R&D.

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

Key Terms

phase 2b, chemotherapy induced neuropathic pain, placebo, statistical power, +4 more

8 terms

phase 2b medical

"ongoing HAL-CINP-203 Phase 2b chemotherapy induced neuropathic pain"

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.

chemotherapy induced neuropathic pain medical

"Phase 2b chemotherapy induced neuropathic pain (“HALT-CINP”) trial."

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.

placebo medical

"separation from placebo treated patients in terms of pain improvement"

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.

statistical power technical

"designed to provide statistical power of approximately >80% to detect"

Statistical power is the probability that a study or test will detect a real effect or difference when one actually exists — like how likely a flashlight will reveal a small object in a dim room. For investors, higher power means study results are more reliable and less likely to miss meaningful benefits or risks, so decisions based on those results carry less chance of being misled by random noise.

randomized medical

"HALT-CINP is a randomized, phase 2b clinical trial evaluating"

Randomized means participants or units in a study are assigned to different groups by chance rather than by choice, like flipping a coin to decide who gets a new treatment and who gets a comparison. For investors, randomized designs matter because they reduce bias and make results more trustworthy, so outcomes from randomized studies carry more weight when assessing regulatory approval, commercial prospects, and the risk that trial results will change a company’s valuation.

sub-cutaneous medical

"Participants receive 8 sub-cutaneous doses of Halneuron® or placebo"

Sub-cutaneous means located just under the skin; in medicine it commonly describes injections or drug delivery into the thin layer of fat and tissue beneath the skin rather than into a vein or muscle. For investors, the route matters because sub-cutaneous medicines can change how easy a drug is to give, how often patients need treatment, and the cost and complexity of manufacturing and regulation—factors that affect market size, adoption, and revenue.

primary endpoint medical

"The primary endpoint for this study is the change in the weekly average"

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.

neuropathy medical

"cancer patients with established neuropathy due to a previous platinum"

Damage or dysfunction of the nerves that carry signals between the brain, spinal cord and the rest of the body, often causing numbness, tingling, weakness or pain like a frayed electrical wire. It matters to investors because neuropathy drives demand for diagnostics, therapies and medical devices, influences healthcare costs and can shape the commercial and regulatory prospects of drugs or technologies aimed at preventing, diagnosing or treating nerve damage.

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

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 - 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 remains on track for top line results to be available during the third quarter of 2026.

“If the HALT-CINP study is successful, Halenuron^® would represent a new therapeutic agent for treating chemotherapy-induced neuropathic pain, a condition for which there are currently no approved therapies. There remains a great need for treatment options for the millions of patients suffering from chemotherapy-induced neuropathic pain and we continue to be encouraged by the rate of enrollment, interim outcomes and safety profile,” said Dogwood Therapeutics Chief Medical Officer R. Michael Gendreau, M.D., Ph.D., “Against a history of failed clinical trials, the ongoing Halneuron^® clinical trial has the potential to be the first statistically significant trial treating chemotherapy-induced neuropathic pain patients under FDA chronic pain study guidance.”

In December 2025, Dogwood announced encouraging results from an interim analysis of 97 patients who had completed treatment in the HALT-CINP study. An 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.   This preliminary evidence of a Halneuron^® treatment effect is noteworthy as patients in the interim analysis population presented with an average duration of chemotherapy-induced neuropathic pain of 5 years. The overall study dropout rate of approximately 4.0% is far below rates typically observed in studies of other FDA approved chronic pain medicines.

The study is designed to provide statistical power of approximately >80% to detect a Halneuron^® treatment difference versus placebo upon study unblinding in the third quarter of 2026.

Halneuron^® CINP Phase 2b Trial Overview (NCT06848348)

HALT-CINP is a randomized, phase 2b clinical trial evaluating the safety and effectiveness of Halneuron^® vs placebo in cancer patients with established neuropathy due to a previous platinum or taxane-based chemotherapy regimen. Participants receive 8 sub-cutaneous 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 in the weekly average of daily 24-hour recall pain intensity scores from baseline to week four. The study is being conducted at approximately 30 sites in the U.S. Secondary measures will assess Halneuron’s^® treatment effects on sleep, fatigue, neuropathy symptoms and overall patient health. Final HALT-CINP Phase 2b trial results are projected for the third quarter of 2026.

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 chemotherapy induced neuropathic pain (“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 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 chemotherapy induced peripheral neuropathy 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 milestone did Dogwood Therapeutics (DWTX) announce about the HALT-CINP trial on Feb 2, 2026?

They reported that HALT-CINP achieved over 50% enrollment and remains on track for Q3 2026 top-line results. According to the company, the trial is randomized, conducted at about 30 U.S. sites, and follows patients for 28 days with a primary endpoint at week four.

When does Dogwood expect top-line results for Halneuron® (DWTX) HALT-CINP Phase 2b?

Top-line results are expected during the third quarter of 2026. According to the company, the study will be unblinded then and was designed with approximately >80% power to detect a treatment difference versus placebo.

What did the interim analysis say about Halneuron® efficacy and safety in the HALT-CINP trial?

An independent review found Halneuron® patients showing separation from placebo on pain improvement in an interim cohort. According to the company, the interim group averaged five years of pain and the study reported a low dropout rate of about 4% indicating tolerability.

How is the HALT-CINP Phase 2b trial of Halneuron® designed for chemotherapy-induced neuropathic pain?

HALT-CINP is a randomized Phase 2b study comparing Halneuron® versus placebo with 8 subcutaneous doses over 14 days and 28-day follow-up. According to the company, the primary endpoint is change in weekly average 24-hour recall pain intensity from baseline to week four.

What are the implications for investors in Dogwood (DWTX) from the 50% enrollment update?

The update indicates trial progress and maintained timing toward Q3 2026 results, reducing execution risk near-term. According to the company, enrollment pace, interim separation from placebo, and low dropouts are cited as encouraging signals for the Phase 2b program.