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Dogwood Therapeutics (DWTX) narrows Q1 loss and advances pain pipeline

Filing Impact
(Moderate)
Filing Sentiment
(Neutral)
Form Type
8-K

Rhea-AI Filing Summary

Dogwood Therapeutics reported first quarter 2026 results, highlighting pipeline progress and stronger finances. The company recorded no revenue, with research and development expenses of $2.7 million and general and administrative expenses of $2.4 million, both modestly higher than a year earlier.

Net loss attributable to common stockholders narrowed to $5.0 million, or $0.15 per share, from $12.2 million, or $8.45 per share, in the first quarter of 2025. Cash and cash equivalents increased to $13.2 million as of March 31, 2026.

Operationally, Halneuron® remains on track for Phase 2b top-line data in chemotherapy-induced neuropathy in fall 2026, and SP16 advanced with FDA acceptance of its investigational new drug application and planned Phase 1b development. Dogwood also announced a worldwide development and commercialization partnership for legacy antiviral assets with potential value up to $100 million for the company and its current and former shareholders.

Positive

  • Dogwood announced a worldwide development and commercialization partnership for legacy antiviral assets with potential value up to $100 million to the company and its current and former shareholders, a meaningful figure relative to total assets of $95.2 million as of March 31, 2026.

Negative

  • None.

Insights

Pipeline advances and a potentially sizable antiviral partnership frame improving quarterly losses.

Dogwood Therapeutics reported a first quarter 2026 net loss of $4.99 million, down from $10.9 million a year earlier, helped by the absence of prior-year debt conversion losses and modest operating cost growth. Cash rose to $13.23 million versus $6.52 million at year-end 2025, supporting near-term development plans.

Strategically, Halneuron® is in a Phase 2b trial for chemotherapy-induced neuropathy with top-line data expected in fall 2026, and SP16 advanced after FDA acceptance of its investigational new drug application. A worldwide development and commercialization partnership for legacy antiviral assets carries potential value up to $100 million to Dogwood and its current and former shareholders, which is notable relative to total assets of $95.2 million as of March 31, 2026.

The company remains pre-revenue and continues to post operating losses, so future outcomes depend on clinical data and execution of the antiviral partnership. Subsequent disclosures may clarify timing and realization of the partnership’s contingent payments and progress of ongoing trials.

Item 2.02 Results of Operations and Financial Condition Financial
Disclosure of earnings results, typically an earnings press release or preliminary financials.
Item 9.01 Financial Statements and Exhibits Exhibits
Financial statements, pro forma financial information, and exhibit attachments filed with this report.
Net loss Q1 2026 $4,986,614 Net loss attributable to common stockholders for Q1 2026
Net loss Q1 2025 $12,181,614 Net loss attributable to common stockholders for Q1 2025
R&D expenses Q1 2026 $2,669,779 Research and development expenses for the quarter ended March 31, 2026
G&A expenses Q1 2026 $2,406,587 General and administrative expenses for the quarter ended March 31, 2026
Cash and cash equivalents $13,227,839 Cash and cash equivalents as of March 31, 2026
Total assets $95,207,871 Total assets as of March 31, 2026
Total stockholders’ equity $80,623,352 Stockholders’ equity as of March 31, 2026
Antiviral partnership potential value $100 million Maximum potential value of worldwide development and commercialization partnership
Chemotherapy Induced Neuropathy medical
"Halneuron® Phase 2b trial in Chemotherapy Induced Neuropathy on track"
Investigational New Drug Application regulatory
"FDA acceptance of SP16 Investigational New Drug Application for the treatment"
An investigational new drug application is a formal request made to regulatory authorities to begin testing a new medication in humans. It is a critical step in the drug development process, as approval indicates the drug has passed initial safety checks and can be studied further. For investors, this signals that a potential new treatment is progressing through its early testing stages, which can impact the company's future growth prospects.
fast track designation regulatory
"Halneuron® has been granted fast track designation from the FDA for the treatment of CINP."
A "fast track designation" is a process that speeds up the review and approval of a product or project, allowing it to reach the market or be completed more quickly than usual. For investors, it can signal that a product may become available sooner, potentially leading to earlier revenue or benefits, and indicating a priority status that might influence company performance and market opportunities.
contingent value rights financial
"under the terms and conditions applicable to the contingent value rights (“CVRs”) issued by Dogwood"
Contingent value rights are special financial instruments that give their holder the potential to receive additional payments if certain future events or conditions happen, such as the achievement of specific business milestones. They are like a promise of extra rewards that depend on how well a project or company performs later on. Investors care about them because they offer a chance for extra gains but also carry uncertainty, as the extra payments are not guaranteed.
Phase 2b medical
"Halneuron®, with Phase 2b data anticipated this fall"
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.
Revenue $0
Net loss attributable to common stockholders $4,986,614
Net loss per share (basic and diluted) $0.15
Cash and cash equivalents $13,227,839
0001818844false00018188442026-05-142026-05-14

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

FORM 8-K

CURRENT REPORT

PURSUANT TO SECTION 13 OR 15(d) OF THE

SECURITIES EXCHANGE ACT OF 1934

Date of Report (Date of earliest event reported):  May 14, 2026

DOGWOOD THERAPEUTICS, INC.

(Exact Name of Registrant as Specified in Charter)

Delaware

001-39811

85-4314201

(State or other jurisdiction
of incorporation)

(Commission
File Number)

(IRS Employer
Identification No.)

44 Milton Avenue

Alpharetta, GA

30009

(Address of principal executive offices)

(Zip Code)

Registrant’s telephone number, including area code:  (866) 620-8655

(Former name or former address, if changed since last report): Not Applicable

Securities registered pursuant to Section 12(b) of the Act:

Title of each class

Trading Symbol(s)

Name of each exchange on which registered

Common Stock, par value $0.0001

DWTX

Nasdaq Capital Market

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging growth company       

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.       ☐

Item 2.02 Results of Operations and Financial Condition.

On May 14, 2026, Dogwood Therapeutics, Inc. (the “Company”) issued a press release announcing the results of operations for the first quarter ended March 31, 2026. A copy of the press release is included as Exhibit 99.1 to this Current Report on Form 8-K and is hereby incorporated by reference into this Item 2.02.

The information provided pursuant to this Item 2.02, including Exhibit 99.1, is being furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934 (the “Exchange Act”) or otherwise subject to the liabilities under that Section and shall not be deemed to be incorporated by reference into any filing of the Company under the Securities Act of 1933 or the Exchange Act.

Item 9.01 Financial Statements and Exhibits.

(d)Exhibits.

Exhibit Number

  ​ ​ ​

Description

99.1

Press Release of the Company, dated May 14, 2026 (furnished herewith).

104

Cover Page Interactive Data File (formatted in Inline XBRL)

2

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

DOGWOOD THERAPEUTICS, INC.

 

 

 

 

By:

/s/ Angela Walsh

 

Name:

Angela Walsh

Title:

Chief Financial Officer, Corporate Secretary and Treasurer

May 14, 2026

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Graphic

Exhibit 99.1

Dogwood Therapeutics Announces First Quarter 2026 Financial Results

- Halneuron® Phase 2b trial in Chemotherapy Induced Neuropathy on track for top-line results in fall 2026 -

- FDA acceptance of SP16 Investigational New Drug Application for the treatment of Chemotherapy Induced Pain and Neuropathy –

- Announces Worldwide Development and Commercialization Partnership for Legacy Antiviral Assets with potential value up to $100M to Dogwood and its current and former shareholders -

ALPHARETTA, Ga., May 14, 2026 -- Dogwood Therapeutics, Inc. (Nasdaq: DWTX) (“Dogwood” or the “Company”), a company that focuses on developing first-in-class, new non-opioid medicines to treat pain and neuropathy, today announced financial results for the first quarter ended March 31, 2026.

“Dogwood is off to a strong operational start to 2026 driven by significant pipeline progress for both Halneuron®, with Phase 2b data anticipated this fall, and SP16, which received FDA clearance to progress into Phase 1b development this quarter,” said Greg Duncan, Chief Executive Officer of Dogwood Therapeutics.  “Furthermore, we executed a global development license for our legacy combination antiviral assets.”

Key Highlights

The Company currently has enrolled 164 patients in its Halneuron® Phase 2b Chemotherapy Induced Neuropathic Pain (“CINP”) study, with top-line results expected fall of 2026.
SP16 granted IND approval from the FDA. Study to begin enrolling in mid-2026 for the treatment of chemotherapy-induced pain and peripheral neuropathy (“CIPPN”). It is fully funded by the National Cancer Institute and will be conducted at the University of Virginia.
In January 2026, the Company completed a financing of up to $26.9 million to progress Halneuron® through Phase 2b development, of which gross proceeds of $12.5 million have been received.
Cash on hand of $13.2 million provides operational runway into the fourth quarter of 2026.

Dogwood Therapeutics Proprietary Pipeline Includes:

Halneuron® is in Phase 2b clinical development as a non-opioid, NaV 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.  Top line results from the ongoing Phase 2b trial are expected in the fall of 2026.
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

1


Graphic

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 Phase 1b CIPPN trial is fully funded by the National Cancer Institute.

First Quarter 2026 Financial Results

Research and development expenses for the first quarter of 2026 were $2.7 million, compared to $2.4 million for the first quarter of 2025. The $0.3 million increase quarter over quarter was primarily related to an increase in drug development costs for Halneuron® of $0.1 million and salaries and related personnel costs of $0.2 million.

General and administrative expenses for the first quarter of 2026 were $2.4 million, compared to $2.0 million for the first quarter of 2025.  The $0.4 million increase quarter over quarter was primarily due to an increase in salaries and related personnel costs of $0.5 million offset by a decrease in franchise fees of $0.1 million.

Net loss attributable to common stockholders for the first quarter of 2026 was $5.0 million or $0.15 basic and diluted net loss per share, compared to a net loss attributable to common stockholders of $12.2 million, or $8.45 basic and diluted net loss per share, for the first quarter of 2025.

About Dogwood Therapeutics

Dogwood Therapeutics (Nasdaq: DWTX) is a development-stage biopharmaceutical company focused on developing first-in-class, non-opioid 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, NaV 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 CIPPN 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.

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Graphic

Development and Commercialization Partnership Payments

To the extent that any payment to Dogwood resulting from the development and commercialization partnership constitutes either an “Upfront Payment” or a “Milestone Payment” under the terms and conditions applicable to the contingent value rights (“CVRs”) issued by Dogwood on October 17, 2024, Dogwood will cause any required amounts to be delivered to the rights agent for further payment to holders of the CVRs.

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

- Financial Tables Follow-

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Graphic

DOGWOOD THERAPEUTICS, INC.

Selected Financial Data

(unaudited)

   

Condensed Consolidated

Statements of Operations Data

Three Months Ended

March 31,

2026

2025

Revenue

$

$

Operating expenses:

Research and development

2,669,779

2,436,998

General and administrative

2,406,587

1,992,928

Total operating expenses

5,076,366

4,429,926

Loss from operations

(5,076,366

)

(4,429,926

)

Other income (expense):

Sublease income

19,455

Loss on debt conversion with related party

(6,134,120

)

Interest income (expense), net

77,350

(147,090

)

Exchange loss, net

(5,860

)

(23,274

)

Total other income (expense), net

90,945

(6,304,484

)

Loss before income taxes

(4,985,421

)

(10,734,410

)

Deferred income tax expense

(1,193

)

(190,542

)

Net Loss

(4,986,614

)

(10,924,952

)

Accrual of paid-in-kind dividends on Series A non-voting convertible preferred stock

(1,256,662

)

Net loss attributable to common stockholders

$

(4,986,614

)

$

(12,181,614

)

Net loss per share of common stock — basic and diluted

$

(0.15

)

$

(8.45

)

Weighted average shares outstanding — basic and diluted

33,544,748

1,441,535

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Graphic

Condensed Consolidated Balance Sheet Data

March 31,

December 31,

2026

2025

Cash and cash equivalents

$

13,227,839

$

6,524,744

Total assets

95,207,871

90,171,237

Total liabilities

14,584,519

15,274,370

Total stockholders’ equity

80,623,352

74,896,867

Source: Dogwood Therapeutics, Inc.

5


FAQ

How did Dogwood Therapeutics (DWTX) perform financially in Q1 2026?

Dogwood reported a Q1 2026 net loss of $4.99 million, or $0.15 per share. The loss narrowed from $12.18 million, or $8.45 per share, in Q1 2025. Operating expenses rose modestly, while total other income improved significantly, helping reduce overall losses.

What were Dogwood Therapeutics' key operating expenses in the first quarter of 2026?

Research and development expenses were $2.67 million and general and administrative expenses were $2.41 million in Q1 2026. Both categories increased versus Q1 2025, mainly due to higher salaries, personnel-related costs, and higher Halneuron® development spending, partially offset by lower franchise fees.

What is the status of Dogwood Therapeutics' Halneuron clinical program?

Halneuron® is in a Phase 2b trial for chemotherapy-induced neuropathy with top-line results expected in fall 2026. The candidate has FDA fast track designation for chemotherapy-induced neuropathic pain and has shown pain reduction in prior clinical studies for cancer-related and chronic CINP-related pain.

What progress has Dogwood Therapeutics made with its SP16 IV candidate?

The FDA accepted the SP16 investigational new drug application for chemotherapy-induced pain and neuropathy. SP16 IV is an LRP1 agonist with anti-inflammatory and potential nerve-repair activity, and its forthcoming Phase 1b CIPPN trial is fully funded by the National Cancer Institute, limiting Dogwood’s direct trial costs.

What is the value of Dogwood Therapeutics' new antiviral partnership?

The worldwide development and commercialization partnership for legacy antiviral assets has potential value up to $100 million to Dogwood and its current and former shareholders. Payments qualifying as upfront or milestone amounts under existing CVRs will be passed through to CVR holders via the rights agent.

What is Dogwood Therapeutics' cash position and balance sheet strength as of March 31, 2026?

Dogwood held $13.23 million in cash and cash equivalents as of March 31, 2026. Total assets were $95.21 million, total liabilities were $14.58 million, and stockholders’ equity was $80.62 million, indicating a balance sheet weighted toward equity financing.

Filing Exhibits & Attachments

4 documents