Dogwood Therapeutics Announces FDA Acceptance of SP16 Investigational New Drug Application for the Treatment of Chemotherapy Induced Pain and Neuropathy

Dogwood Therapeutics (NASDAQ: DWTX) announced FDA acceptance of an IND for SP16, an IV candidate to treat chemotherapy-induced pain and peripheral neuropathy (CIPPN).

Rhea-AI Summary

Dogwood Therapeutics (NASDAQ: DWTX) announced FDA acceptance of an IND for SP16, an IV candidate to treat chemotherapy-induced pain and peripheral neuropathy (CIPPN). Serpin Pharma is regulatory sponsor; a $2.5 million NCI grant will fully fund the planned Phase 1b trial, with enrollment expected mid-2026.

Dogwood holds a royalty-free global license to Serpin’s IV SP16 formulation acquired in September 2025.

Positive

• FDA IND accepted for SP16, a clinical regulatory milestone
• $2.5M NCI grant fully funds the SP16 Phase 1b trial
• Royalty-free global license to Serpin’s IV SP16 secured Sept 2025
• Patient enrollment for Phase 1b expected mid-2026

Negative

• No human efficacy or safety data reported yet for SP16
• Serpin Pharma is the IND holder and regulatory sponsor, creating dependency
• SP16 currently entering only Phase 1b, clinical benefit still unproven

Argus Apr 15 session

-4.47% close to close Open Argus

Details

News Market Reaction – DWTX

On Apr 15, the day this news came out, DWTX closed 4.47% below the previous close.

Data tracked by StockTitan Argus for the Apr 15 session.

Key Figures

NCI grant: $2.5 million Phase 1b start timing: Middle of 2026 CIPPN incidence: 30–40% +2 more

NCI grant

$2.5 million

Grant to fully fund SP16 Phase 1b CIPPN trial

Phase 1b start timing

Middle of 2026

Expected start of patient enrollment for SP16 Phase 1b at UVA

CIPPN incidence

30–40%

Patients affected six months after neurotoxic chemotherapy

Time to assessment

Six months

Post-chemotherapy timeframe referenced for CIPPN incidence

SP16 license date

September 2025

Date Dogwood secured global, royalty-free SP16 license

Previous Clinical trial Reports

3 past events · Latest: Dec 22

Same Type 3 events

1. Dec 22

   Interim Phase 2b data

   24h Move

   -25.0%

   Positive interim Phase 2b CINP results showing Halneuron outperformed placebo.

2. Mar 18

   Phase 2b dosing start

   24h Move

   -6.9%

   Initiation of dosing in Phase 2b CINP trial for Halneuron with prior positive data.

3. Jan 21

   Phase 2b dosing plan

   24h Move

   +68.5%

   Announcement of Phase 2b dosing start timeline for Halneuron in CINP patients.

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

Key Terms

investigational new drug, iv infusion, il-6, tnf-alpha, +3 more

7 terms

investigational new drug regulatory

"announced FDA acceptance of an Investigational New Drug (“IND”) application"

An investigational new drug is a medication that is still being tested in clinical trials to determine if it is safe and effective for treating a specific condition. For investors, it represents a potential breakthrough that could lead to a new treatment and significant financial gains if successful, but also carries risks since it has not yet been approved for widespread use.

iv infusion medical

"SP16 is administered via IV infusion with two hypothesized actions"

An IV infusion is the delivery of fluids, medicines or nutrients directly into a vein through a small tube over a set period, like a controlled fuel line topping up a machine. For investors, IV infusion matters because many approved therapies and some high-value treatments require this route of administration, affecting how treatments are delivered, the costs and capacity of clinics or hospitals, reimbursement and the recurring revenue potential of providers.

il-6 medical

"anti-inflammatory actions via reduction of IL-6, IL-8, IL-1β and TNF-alpha"

Interleukin-6 (IL-6) is a small signaling protein the body releases as an alarm during infection, injury, or chronic inflammation; think of it as a smoke detector that calls immune cells to action. It matters to investors because IL-6 levels can serve as a biomarker for disease severity and a target for therapies—drugs that block or modulate IL-6 can change treatment outcomes, regulatory decisions, and commercial prospects in healthcare markets.

tnf-alpha medical

"reduction of IL-6, IL-8, IL-1β and TNF-alpha, and tissue repair"

Tumor necrosis factor-alpha (TNF-alpha) is a small signaling protein the body uses to trigger and regulate inflammation, like a fire alarm that summons immune cells to a problem site. Investors watch it because elevated or controlled TNF-alpha levels are central to many inflammatory and autoimmune diseases, making it a common target for drugs and diagnostics; success or failure of therapies that block or measure TNF-alpha can greatly affect company value and market prospects.

pakt medical

"tissue repair via increases in pAKT and pERK that regulate and promote"

A pakt is an agreement or formal deal between two or more parties that sets out mutual promises, responsibilities and often specific milestones or payments. For investors, a pakt matters because it can change a company’s future cash flow, legal obligations or strategic direction—think of it like a marriage contract that binds both sides to certain actions and consequences, so it can create value or add risk depending on the terms.

perk medical

"tissue repair via increases in pAKT and pERK that regulate and promote"

A perk is an extra benefit or non-salary reward provided to employees, executives, or sometimes shareholders—examples include company cars, stock options, discounts, or special services. Investors care because perks represent real costs or incentives that affect a company’s profitability, ability to retain talent, and corporate governance; like bonus features on a product, they can make a company more attractive but also add hidden expense or risk.

peripheral neuropathy medical

"for the treatment of chemotherapy-induced pain and peripheral neuropathy"

A condition where nerves outside the brain and spinal cord are damaged, causing numbness, tingling, pain or weakness—like faulty wiring that sends mixed or dropped signals between the brain and parts of the body. Investors watch it because it drives demand for drugs, medical devices and diagnostics, shapes clinical trial results and regulatory decisions, and can influence healthcare costs, company revenues and legal risk in related industries.

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

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Dogwood licensed SP16 to treat cancer-related pain from partner and regulatory sponsor Serpin Pharma

The SP16 Phase 1b trial fully funded by the National Cancer Institute; Patient enrollment expected to commence in the middle of 2026 at the University of Virginia

ALPHARETTA, Ga., April 15, 2026 (GLOBE NEWSWIRE) -- Dogwood Therapeutics, Inc. (NASDAQ: DWTX) (“DWTX”, “Dogwood” or “the Company”), a company that focuses on developing new non-opioid medicines to treat pain and neuropathy, today announced FDA acceptance of an Investigational New Drug (“IND”) application for its development candidate SP16, administered intravenously (“IV”), for the treatment of chemotherapy-induced pain and peripheral neuropathy (“CIPPN”).

SP16 is administered via IV infusion with two hypothesized actions: anti-inflammatory actions via reduction of IL-6, IL-8, IL-1β and TNF-alpha, and tissue repair via increases in pAKT and pERK that regulate and promote fundamental processes like growth, proliferation, and survival. The Company and its partner Serpin Pharma anticipate patient enrollment in the SP16 Phase 1b trial to begin in the middle of 2026. Serpin Pharma has been awarded a $2.5 million grant from the National Cancer Institute (“NCI”), which will fully fund the forthcoming SP16 Phase 1b CIPPN clinical trial.

“FDA acceptance of our SP16 IND filing represents an important step in expanding our pipeline as we advance a second development candidate into the clinic to treat chemotherapy-induced neuropathy and pain,” said Greg Duncan, Chairman and Chief Executive Officer of Dogwood Therapeutics. “SP16 compliments our lead candidate, Halneuron^®, by not only targeting neuropathic pain but also addressing additional debilitating symptoms of neurotoxic chemotherapy, including numbness, tingling and impaired motor function.”

Incidence of CIPPN is high, affecting approximately 30-40% of patients six months after receiving neurotoxic chemotherapy, and can persist long-term in many patients.   Key risk factors for the development of these symptoms include use of platinum or taxane containing drugs, higher chemotherapeutic doses, and underlying diabetes. Common symptoms associated with CIPPN are numbness, tingling, and pain, symptoms that directly impact quality of life in these cancer survivors. 

In September 2025, Dogwood secured the SP16 royalty-free, global license to develop and commercialize Serpin Pharma’s IV formulation of SP16 to manage CIPPN. Serpin Pharma is the holder of the IND and the regulatory sponsor of the program.

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 CIPPN 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 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 (DWTX) announce about SP16 on April 15, 2026?

Dogwood announced FDA acceptance of an IND for SP16 to treat chemotherapy-induced pain and neuropathy. According to the company, Serpin Pharma is the regulatory sponsor and a $2.5M NCI grant will fully fund the Phase 1b trial.

When will the SP16 Phase 1b trial for DWTX begin enrolling patients?

Patient enrollment is expected to begin mid-2026 for the SP16 Phase 1b trial. According to the company, the study will commence at the University of Virginia and is fully funded by an NCI grant.

How is the SP16 Phase 1b trial for DWTX being funded?

The SP16 Phase 1b trial is fully funded by a $2.5 million grant awarded to Serpin Pharma by the National Cancer Institute. According to the company, this grant will cover the upcoming CIPPN study costs.

What is Dogwood’s (DWTX) licensing position on SP16?

Dogwood holds a royalty-free, global license to develop and commercialize Serpin’s IV SP16 formulation. According to the company, the license was secured in September 2025 and covers CIPPN development.

What mechanisms of action does SP16 have for chemotherapy-induced neuropathy?

SP16 is hypothesized to reduce inflammation and support tissue repair via IL-6/IL-8/IL-1β/TNF-alpha reduction and increased pAKT/pERK. According to the company, these actions aim to address pain, numbness, and motor impairment associated with CIPPN.