Dogwood Therapeutics Files New Synthetic Halneuron(R) Intellectual Property Protection Projected to Extend Exclusivity Period Up to 2045

Rhea-AI Summary

Dogwood Therapeutics (Nasdaq: DWTX) filed a new composition of matter intellectual property application for a fully synthetically manufactured Halneuron® on December 2, 2025. The company says the synthetic process delivers higher manufacturing yields and lower costs versus naturally harvested Halneuron® and is planned for use in Phase 3 development and commercialization. If the IP is granted, Dogwood projects the exclusivity period could extend to 2045, before any additional patent term restoration.

Positive

• Filed composition-of-matter IP for synthetic Halneuron
• Synthetic process claims higher manufacturing yields
• Synthetic process claims reduced manufacturing costs
• Company plans to use synthetic Halneuron in Phase 3 and commercialization
• Projected exclusivity extension to 2045 if IP granted

Negative

• Exclusivity extension is contingent on IP grant, not guaranteed

Key Figures

Projected exclusivity to 2045 If new synthetic Halneuron® IP is granted

Planned Phase 2b size 200 patients HALT-CINP Phase 2b trial target enrollment

Patients enrolled 100 patients First 100 patients enrolled in Halneuron® Phase 2b

Q3 2025 net loss $15.7M Quarter ended September 30, 2025

Cash balance $10.1M Q3 2025 cash, runway through Q1 2026

Registered resale shares 28,038,689 shares Shares registered under Form S-3/A for selling stockholders

Shares outstanding 2,293,162 shares Common shares outstanding as of October 16, 2025

Price vs 52-week high -78.07% Versus 52-week high of $29.28 before this news

Market Reality Check

$3.15 Last Close

Volume Volume 20,947 is below the 20-day average of 28,382 (relative volume 0.74x). normal

Technical Price $6.42 is trading above the 200-day MA at $5.34.

Peers on Argus 1 Up

DWTX slipped 0.5% while close biotech peers were mixed: CYCCP -5.61%, APRE -0.53%, PCSA -3.48%, RNAZ +6.33%, AEON flat. Momentum scanner flagged only GLMD moving up, suggesting today’s setup looks more stock-specific than a broad sector move.

Historical Context

Date	Event	Sentiment	Move	Catalyst
Dec 02	IP extension news	Positive	-2.0%	Filed new composition-of-matter IP for synthetic Halneuron® to extend exclusivity.
Nov 11	Clinical trial update	Positive	+1.4%	Reported first 100 patients enrolled in Halneuron® Phase 2b, interim analysis on track.
Nov 06	Q3 2025 earnings	Negative	-6.5%	Disclosed higher R&D, <b>$15.7M</b> net loss and going-concern uncertainty beyond Q1 2026.
Oct 30	Earnings date notice	Neutral	+7.8%	Announced timing of Q3 2025 financial results release before market open.
Oct 14	Conference participation	Neutral	+1.0%	Flagged CEO participation and investor meetings at Maxim Growth Summit 2025.

Pattern Detected

Recent news often draws pronounced moves: earnings and capital-structure updates saw larger swings, while clinical and IP updates produced moderate reactions, including one negative move on seemingly positive IP news.

Recent Company History

Over the last few months, Dogwood reported multiple milestones around Halneuron® and its capital structure. A Q3 2025 update showed a net loss of $15.7M and cash of $10.1M, with runway through Q1 2026. Clinically, Halneuron®’s Phase 2b trial enrolled the first 100 patients toward a planned 200‑patient dataset. Corporate actions included preferred-share conversions and Nasdaq-related approvals. Today’s IP filing, aiming to extend synthetic Halneuron® exclusivity potentially to 2045, builds on this strategy of strengthening the lead asset’s commercial and regulatory positioning.

Regulatory & Risk Context

Active S-3 Shelf Registration 2025-10-16

An effective Form S-3/A filed on 2025-10-16 registers up to 28,038,689 common shares for resale by existing holders. The company itself is not selling shares and will not receive proceeds, but the registration enables selling stockholders like Sealbond Limited and Conjoint Inc. to dispose of registered shares over time, potentially affecting trading dynamics.

Market Pulse Summary

This announcement centers on a new composition-of-matter IP filing for fully synthetic Halneuron®, which, if granted, could extend exclusivity to 2045 and support Phase 3 development and commercialization. In context, Dogwood recently reported a Q3 net loss of $15.7M, cash of $10.1M with runway through Q1 2026, and ongoing Halneuron® Phase 2b enrollment toward 200 patients. Investors may track future patent outcomes, trial data, and funding steps alongside this IP strategy.

Key Terms

composition of matter regulatory

"New Composition of Matter Intellectual Property ("IP") Filing Centered on..."

Composition of matter describes the specific chemical makeup and structure of a substance — essentially the “recipe” of which atoms or molecules are present and how they are arranged. For investors, it matters because that precise recipe is what patents, regulatory approvals, and product claims protect; control over a unique composition can create market exclusivity, influence manufacturing costs, and drive a company’s valuation or licensing potential.

intellectual property regulatory

"announced it has filed for new intellectual property protection for synthetic..."

Intellectual property are legal rights that protect creations of the mind—such as inventions, brand names, designs, software, or secret formulas—giving the owner control over who can use, copy or sell them. For investors, IP is like owning a blueprint or recipe: it can generate steady income through exclusive sales or licensing, boost a company’s competitive edge and valuation, and also create costs or risks if rights must be defended or challenged in court.

phase 3 medical

"We plan to use synthetically manufactured Halneuron® in both Phase 3 development..."

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.

exclusivity period regulatory

"If granted, the IP's exclusivity period will extend to 2045..."

An exclusivity period is a set amount of time during which only one party has the right to buy, sell, or make a deal with an asset or opportunity. For investors, it matters because it limits competition and gives the holder a guaranteed window to decide or act without interference from others, similar to having a temporary special right or first chance to make a move.

AI-generated analysis. Not financial advice.

- New Composition of Matter Intellectual Property ("IP") Filing Centered on First-in-Class, Fully Synthetically Manufactured Halneuron^®-

- New Synthetic Process to be Used for Phase 3 Development Provides Higher Manufacturing Yields and Reduces Costs Versus Naturally Harvested Halneuron^® -

ATLANTA, GA / ACCESS Newswire / December 2, 2025 / Dogwood Therapeutics, Inc. (Nasdaq:DWTX) (the "Company"), a development-stage biotechnology company developing new medicines to treat pain and neuropathy, today announced it has filed for new intellectual property protection for synthetic Halneuron^®. If granted, the IP's exclusivity period will extend to 2045, before additional patent term restoration extensions.

"We plan to use synthetically manufactured Halneuron^® in both Phase 3 development and commercialization," said Greg Duncan, Dogwood Therapeutics Chief Executive Officer. "This new synthetic process builds on our proprietary and best-in-class manufacturing know-how, with potential to reset our exclusivity period for 20 years, thus providing ample opportunity to deliver Halneuron's^® full commercial potential."

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 ("CINP"). 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 the 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 (LRP1) agonist 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.

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

SOURCE: Dogwood Therapeutics, Inc.

View the original press release on ACCESS Newswire

FAQ

What did Dogwood Therapeutics announce on December 2, 2025 regarding Halneuron (DWTX)?

Dogwood filed a new composition-of-matter IP application for fully synthetic Halneuron®, aiming to extend exclusivity to 2045 if granted.

How will the synthetic Halneuron process affect manufacturing for DWTX?

The company says the synthetic process provides higher yields and reduced costs versus naturally harvested Halneuron®.

Will Dogwood use synthetically manufactured Halneuron in clinical trials for DWTX?

Yes; Dogwood plans to use synthetically manufactured Halneuron® in Phase 3 development and for commercialization.

If Dogwood's IP is granted, how long could Halneuron exclusivity last for DWTX?

Dogwood projects the new IP could extend exclusivity through 2045, before any patent term restoration adjustments.

Does the December 2, 2025 filing mean exclusivity is already secured for DWTX?

No; the company has filed the application but the exclusivity extension depends on the IP being granted.