Dogwood Therapeutics Announces Commencement of Halneuron® Chemotherapy Induced Neuropathic Pain Phase 2b Long Term Extension Study

Dogwood Therapeutics (NASDAQ:DWTX) began a 12-week open-label Phase 2b extension study of Halneuron for chemotherapy induced neuropathic pain (CINP).

Rhea-AI Summary

Dogwood Therapeutics (NASDAQ:DWTX) began a 12-week open-label Phase 2b extension study of Halneuron for chemotherapy induced neuropathic pain (CINP). The trial follows a positive interim assessment of a 4-week double-blind study and will collect additional safety and efficacy data.

Interim analysis based on 97 patients supported continuing the Phase 2b trial with a 210–240 patient sample to achieve 80% power. Top-line Phase 2b results are expected in fall 2026, with a Phase 3 program projected to start in the first half of 2027.

Positive

• Phase 2b 12-week Halneuron CINP extension study has commenced
• Interim analysis supported continuing Phase 2b with 210–240 patient sample for 80% power
• Top-line Phase 2b CINP results targeted for release in fall 2026
• Phase 3 Halneuron CINP program projected to begin in first half of 2027
• Overall Phase 2b CINP study dropout rate currently under 5%

Negative

• None.

Argus May 18 session

-7.10% close to close Open Argus

Details

News Market Reaction – DWTX

On May 18, the day this news came out, DWTX closed 7.10% below the previous close.

Data tracked by StockTitan Argus for the May 18 session.

Market Context

On May 18, the day this news came out, the stock closed 7.1% below the previous close. A negative re...

Analysis

On May 18, the day this news came out, the stock closed 7.1% below the previous close. A negative reaction despite the constructive long‑term extension update fits a pattern where positive pipeline news has sometimes met selling. The stock already traded about 80.74% below its 52‑week high and below its 200‑day MA of $4.14, with an effective resale S‑3 covering 6,433,126 shares and prior going‑concern language in filings. Those structural and dilution overhangs may have weighed more heavily than incremental Phase 2b design progress.

Key Figures

Extension duration: 3 months (12-week) Planned Phase 3 start: First half of 2027 Phase 2b sample size: 210–240 patients +5 more

Extension duration

3 months (12-week)

Halneuron® Phase 2b long-term extension treatment period

Planned Phase 3 start

First half of 2027

Projected start of Halneuron® Phase 3 development program

Phase 2b sample size

210–240 patients

Target CINP Phase 2b sample size for 80% power

Interim analysis patients

97 patients

Patients completing trial in Phase 2b interim analysis

Study dropout rate

Under 5%

Overall dropout in ongoing CINP Phase 2b trial

Mean CINP duration

Over five years

Average duration of chemotherapy-induced neuropathic pain in enrollees

Registered resale shares

6,433,126 shares

Form S-3 resale registration for existing investor

Price vs 52-week high

-80.74%

Distance from 52-week high of $9.50 at $1.83 share price

Historical Context

5 past events · Latest: May 14

5 events

1. May 14

   Q1 2026 earnings

   24h Move

   +6.5%

   Quarterly results, Halneuron® progress, SP16 IND clearance, and cash runway update.

2. May 07

   Earnings date notice

   24h Move

   -5.5%

   Announcement of timing for upcoming Q1 2026 financial results release.

3. Apr 23

   Antiviral partnership

   24h Move

   -8.5%

   Global development and commercialization deal for antiviral assets with up to $100M value.

4. Apr 15

   SP16 IND accepted

   24h Move

   -4.5%

   FDA acceptance of SP16 IND and NCI-funded Phase 1b CIPPN trial plan.

5. Mar 18

   FY 2025 earnings

   24h Move

   -7.8%

   Full-year 2025 results, Halneuron® interim data, and financing to extend cash runway.

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

Key Terms

phase 2b, open-label, double-blinded, chemotherapy induced neuropathic pain, +3 more

7 terms

phase 2b medical

"new Halneuron® chemotherapy induced neuropathic pain (“CINP”) phase 2b extension study."

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.

open-label medical

"new 12-week open-label follow-on trial"

Open-label describes a situation where everyone involved in a study or process knows the full details, such as who is receiving a treatment or intervention. For investors, understanding whether a project or product is open-label helps gauge the level of transparency and potential biases, influencing trust and decision-making. It’s like knowing whether a test or experiment is conducted openly or behind closed doors.

double-blinded medical

"patients completing the 4-week double-blinded treatment period."

A double-blinded study is a test where neither the participants nor the people administering the treatments know who is getting which version, so expectations can't influence the results. For investors, that fairness check makes clinical or product test results more reliable—think of it like a blind taste test where both the taster and server are kept unaware—so positive outcomes from double-blinded studies carry more weight for valuation and regulatory confidence.

chemotherapy induced neuropathic pain medical

"Halneuron® chemotherapy induced neuropathic pain (“CINP”) phase 2b extension study."

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.

fda regulatory

"plans to FDA to support commencement of a Halneuron® 12-week follow-on"

The FDA is the U.S. federal agency that evaluates and approves medical drugs, devices, biological therapies and certain foods; think of it as the gatekeeper that decides whether a medical product is safe and effective for patients. For investors, FDA decisions determine whether a company can sell a product, affect expected revenue and introduce regulatory risk, so approvals, rejections or safety warnings can quickly move a company's valuation and stock price.

phase 3 medical

"planned Phase 3 development program, presently projected to start"

Phase 3 is the late-stage clinical testing step for a new drug or medical treatment, where the product is given to large groups of patients to confirm effectiveness, monitor side effects, and compare it to standard care. Successful Phase 3 results are often the final scientific hurdle before regulators decide on approval and market launch—like passing a final exam before graduation—and can sharply change a company's valuation and future revenue prospects.

neuropathic pain medical

"Neuropathic pain is a difficult to treat chronic condition"

Neuropathic pain is chronic pain caused by damage or dysfunction in the nerves, often described as burning, tingling, electric shocks or numbness rather than pain from injury. It matters to investors because it represents a large, persistent patient population and a tough-to-treat condition where successful therapies, devices or diagnostics can generate steady demand, premium pricing and regulatory attention; think of it like faulty wiring in a house that causes random shocks and needs specialized fixes.

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

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New study to assess Halneuron^® pain reduction effect over three months of treatment, additional safety data to bolster planned end of Phase 2 FDA submission package

Patients completing the ongoing Halneuron^® 4-week CINP Phase 2b study are now eligible to enroll in the new 12-week open-label follow-on trial

ALPHARETTA, Ga., May 18, 2026 (GLOBE NEWSWIRE) -- Dogwood Therapeutics, Inc. (NASDAQ: DWTX) (“Dogwood” or the “Company”), a biopharmaceutical company developing first-in-class, non-opioid medicines to treat pain and neuropathy, today announced commencement of a new Halneuron^® chemotherapy induced neuropathic pain (“CINP”) phase 2b extension study. Based on a positive interim assessment demonstrating a Halneuron^® 4-week treatment effect versus placebo, Dogwood previously submitted plans to FDA to support commencement of a Halneuron^® 12-week follow-on open-label extension study for patients completing the 4-week double-blinded treatment period. Several patients have already been enrolled in the new study that will assess the safety and efficacy of continued Halneuron^® treatment for an additional 3 months, using various dosing regimens. Data from the forthcoming extension trial will add to the data package the Company plans to submit to the FDA to support its planned Phase 3 development program, presently projected to start in the first half of 2027.

Dogwood Therapeutics previously announced that a pre-planned interim analysis of the double-blinded Halneuron^® CINP Phase 2b study supported continuation of the study, with a sample size in the 210-240 range to achieve 80% power. This recommendation by an independent group of statisticians was based on the observed treatment difference between Halneuron^®-treated and placebo-treated patients amongst the 97 patients completing the trial. The double-blinded portion of the ongoing CINP study is expected to meet enrollment objectives to support release of top-line results in the fall of 2026. The current overall study dropout rate of under 5% is far below rates typically observed during other FDA-approved chronic pain clinical studies. Patients completing the ongoing CINP Phase 2b trial will be eligible to receive Halneuron^® for an additional 12 weeks to control their moderate-to-severe pain following chemotherapy treatment. A review of the demographics of the patients included in the interim analysis revealed that the mean duration of CINP for study enrollees exceeded five years, demonstrating the extraordinary medical need for novel new medicines to improve care for patients suffering from CINP. Currently, there are no FDA-approved treatments for CINP patients.

“Neuropathic pain is a difficult to treat chronic condition, as evidenced by the five-year mean duration of symptoms for the patients enrolling in our current Halneuron^® CINP Phase 2b trial,” commented R. Michael Gendreau, MD, Chief Medical Officer of Dogwood. “This new 12-week long term extension will generate important additional data on how best to optimize Halneuron^® maintenance treatment for our planned Phase 3 program and potential commercialization.”

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.

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. 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 pain and peripheral neuropathy 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 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 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 did Dogwood Therapeutics (NASDAQ:DWTX) announce about the Halneuron CINP trial on May 18, 2026?

Dogwood announced the start of a 12-week open-label Phase 2b extension study of Halneuron for chemotherapy induced neuropathic pain. According to the company, this follow-on trial enrolls patients completing the initial 4-week double-blind study to gather longer-term safety and efficacy data.

How long will patients receive Halneuron in the new Dogwood Therapeutics Phase 2b CINP extension study (DWTX)?

Patients in the new Halneuron Phase 2b CINP extension study will receive treatment for an additional 12 weeks. According to Dogwood, this three-month period will evaluate continued safety and pain reduction using various dosing regimens after the initial 4-week double-blind phase.

What did the interim analysis show in Dogwood Therapeutics’ Halneuron Phase 2b CINP trial (NASDAQ:DWTX)?

The interim analysis supported continuation of the Halneuron Phase 2b CINP trial with a 210–240 patient sample for 80% power. According to Dogwood, this recommendation was based on treatment differences observed between Halneuron and placebo among 97 patients who completed the trial.

When are top-line results expected from Dogwood Therapeutics’ Halneuron Phase 2b CINP study (DWTX)?

Top-line results from the double-blinded portion of the Halneuron Phase 2b CINP study are expected in fall 2026. According to Dogwood, enrollment is projected to meet objectives needed to support this timing and inform future regulatory and development plans.

When could Dogwood Therapeutics (NASDAQ:DWTX) start a Phase 3 program for Halneuron in CINP?

Dogwood projects that the Halneuron Phase 3 development program for chemotherapy induced neuropathic pain could begin in the first half of 2027. According to the company, data from the 12-week extension will support the FDA submission package for this Phase 3 plan.

What is notable about patient retention in Dogwood Therapeutics’ Halneuron CINP Phase 2b trial (DWTX)?

The overall dropout rate in the ongoing Halneuron CINP Phase 2b study is currently under 5%. According to Dogwood, this rate is described as far below dropout levels typically observed in other chronic pain clinical studies approved by the FDA.

Why is Dogwood Therapeutics studying Halneuron for chemotherapy induced neuropathic pain (NASDAQ:DWTX)?

Dogwood is studying Halneuron for CINP because enrolled patients show a mean symptom duration exceeding five years and there are currently no FDA-approved treatments. According to the company, this highlights a strong unmet need for new non-opioid pain therapies.