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Dogwood Therapeutics (DWTX) posts $11.5M Q2 loss as Halneuron trial advances

(Moderate)
(Neutral)
Form Type
8-K

Rhea-AI Filing Summary

Dogwood Therapeutics, Inc. reported second quarter 2026 results with no revenue and a focus on advancing its non-opioid pain pipeline. The Halneuron® Phase 2b trial in chemotherapy-induced neuropathic pain is on track for top-line data in fall 2026, with 217 patients enrolled and plans to enroll over 220 patients to provide more than 80% statistical power.

For the quarter ended June 30, 2026, research and development expenses were $3.25 million and general and administrative expenses were $1.63 million. Dogwood recorded a non-cash IPR&D impairment charge of $9.19 million, leading to a net loss attributable to common stockholders of $11.53 million, or $0.34 per share. Cash was $9.61 million as of June 30, 2026.

Strategically, Dogwood highlighted a worldwide development and commercialization partnership for legacy antiviral assets with potential value of up to $100 million for the company and its CVR holders, the start of a Phase 2b long-term extension study of Halneuron®, and a fully National Cancer Institute–funded forthcoming SP16 IV Phase 1b trial.

Positive

  • Halneuron® Phase 2b CINP trial advancing: 217 patients enrolled with top-line data expected in fall 2026 and plans to enroll over 220 patients to achieve >80% statistical power.
  • Potentially meaningful antiviral partnership economics: worldwide development and commercialization partnership for legacy antiviral assets with potential value of up to $100 million to Dogwood and its CVR holders.
  • Non-dilutive support for SP16 IV program: forthcoming SP16 IV Phase 1b CIPPN trial is fully funded by the National Cancer Institute, reducing direct trial cost burden on Dogwood.
  • Halneuron® regulatory and clinical profile: lead asset has FDA fast track designation for CINP and has shown statistically significant, durable pain reduction with an acceptable safety profile in clinical data to date.

Negative

  • Large non-cash IPR&D impairment: Dogwood recorded an IPR&D impairment of $9.19 million in Q2 2026, contributing to a net non-cash impairment charge of $6.7 million following a decline in market capitalization.
  • Substantial quarterly net loss: net loss attributable to common stockholders for Q2 2026 was $11.53 million, or $0.34 per share, compared to $3.81 million, or $1.99 per share, for Q2 2025.
  • Rising operating expenses: total operating expenses increased to $14.06 million in Q2 2026 from $3.92 million in Q2 2025, reflecting higher R&D, G&A, and the IPR&D impairment.
  • No current product revenue: revenue remained $0 for both the three- and six-month periods ended June 30, 2026 and 2025, underscoring continued reliance on external funding rather than commercial sales.

Filing Explained

For the announced antiviral partnership, any payment qualifying as an “Upfront Payment” or “Milestone Payment” under Dogwood’s October 17, 2024 CVRs must be delivered to the rights agent for onward payment to CVR holders.

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.
Research and development expense Q2 2026 $3,246,519 Three months ended June 30, 2026
General and administrative expense Q2 2026 $1,626,109 Three months ended June 30, 2026
IPR&D impairment Q2 2026 $9,190,897 Recorded as operating expense in the quarter ended June 30, 2026
Net loss attributable to common stockholders Q2 2026 $11,529,609 Three months ended June 30, 2026; basic and diluted net loss per share $0.34
Cash balance $9,610,033 Cash as of June 30, 2026
Total stockholders’ equity $68,366,108 As of June 30, 2026
Patients enrolled in Halneuron Phase 2b 217 patients Chemotherapy-induced neuropathic pain Phase 2b trial enrollment status
Potential value of antiviral partnership up to $100 million Worldwide development and commercialization partnership for legacy antiviral assets
Chemotherapy Induced Neuropathy medical
"Halneuron® Phase 2b trial in Chemotherapy Induced Neuropathy on track"
IPR&D impairment financial
"recognized a net non-cash impairment charge of $6.7 million. This IPR&D impairment"
fast track designation regulatory
"Halneuron® has been granted fast track designation from the FDA for the treatment of CINP"
Fast track designation is a status the U.S. Food and Drug Administration grants to drugs intended to treat serious conditions and address an unmet medical need. It gives the developer more frequent communication with the FDA and can allow parts of the application to be reviewed on a rolling basis, and it may pave the way to priority review or accelerated approval. It can shorten development timelines, though it does not guarantee approval.
contingent value rights financial
"contingent value rights (“CVRs”) issued by Dogwood on October 17, 2024"
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.
NaV 1.7 analgesic medical
"Halneuron® is a non-opioid, NaV 1.7 analgesic which is a highly specific voltage-gated"
Revenue $0 No revenue reported for Q2 or first half of 2026, consistent with 2025
Net loss attributable to common stockholders Q2 2026 $11,529,609 Compared to $3,807,353 for Q2 2025, reflecting higher operating expenses and IPR&D impairment
R&D expenses Q2 2026 $3,246,519 $0.6 million increase quarter over quarter primarily related to Halneuron Phase 2b CINP study costs
G&A expenses Q2 2026 $1,626,109 $0.3 million increase quarter over quarter driven by higher salaries, personnel costs and franchise fees
IPR&D impairment Q2 2026 $9,190,897 New non-cash impairment in 2026; no comparable amount in Q2 2025
Cash as of June 30, 2026 $9,610,033 Reported alongside total assets of $80,495,480 and stockholders’ equity of $68,366,108

FAQ

What were Dogwood Therapeutics (DWTX) key financial results for Q2 2026?

Dogwood reported no revenue and a net loss attributable to common stockholders of $11.53 million, or $0.34 per share, for the quarter ended June 30, 2026, driven largely by a $9.19 million IPR&D impairment and ongoing R&D and G&A expenses.

How is Dogwood Therapeutics (DWTX) progressing its Halneuron® CINP program?

The Halneuron® Phase 2b trial in chemotherapy-induced neuropathic pain has 217 patients enrolled and remains on track for top-line results in fall 2026. Dogwood plans to enroll over 220 patients to achieve more than 80% statistical power to detect a clinically significant pain reduction.

What is the size of Dogwood Therapeutics’ (DWTX) impairment recorded in Q2 2026?

Dogwood recognized an IPR&D impairment of $9.19 million in Q2 2026, partially offset by a $2.48 million deferred income tax benefit, resulting in a net non-cash impairment charge of $6.7 million, which management stated does not affect the company’s cash runway.

What partnership economics did Dogwood Therapeutics (DWTX) highlight in this update?

Dogwood announced a worldwide development and commercialization partnership for its legacy antiviral assets with potential value up to $100 million to Dogwood and its CVR holders. Any qualifying upfront or milestone payments will be shared with CVR holders under existing contingent value right terms.

What is Dogwood Therapeutics’ (DWTX) cash and balance sheet position as of June 30, 2026?

As of June 30, 2026, Dogwood reported cash of $9.61 million, total assets of $80.50 million, total liabilities of $12.13 million, and stockholders’ equity of $68.37 million, reflecting a development-stage biopharmaceutical capital structure without product revenue.

How are SP16 IV development costs handled for Dogwood Therapeutics (DWTX)?

Dogwood stated that the forthcoming SP16 IV Phase 1b CIPPN trial is fully funded by the National Cancer Institute. This external funding supports advancement of SP16 IV’s neuropathy program while limiting direct clinical trial spending by the company.

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

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0001818844false00018188442026-08-132026-08-13

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):  August 13, 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 August 13, 2026, Dogwood Therapeutics, Inc. (the “Company”) issued a press release announcing the results of operations for the second quarter ended June 30, 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 August 13, 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

August 13, 2026

3

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Exhibit 99.1

Dogwood Therapeutics Announces Second Quarter 2026 Financial Results

- Halneuron® Phase 2b trial in Chemotherapy Induced Neuropathy on track for top-line results in fall 2026, 217 patients enrolled –

- Commencement of Phase 2b Long-Term Extension Study to assess Halneuron® reduction in pain over three months of treatment –

- Appointment of Iain Dukes, D.Phil., Venture Partner at OrbiMed, as Chair of Scientific Advisory

Board –

- Announced Worldwide Development and Commercialization Partnership for Legacy Antiviral Assets with potential value up to $100M to Dogwood Therapeutics and its CVR Holders –

ALPHARETTA, Ga., August 13, 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 second quarter ended June 30, 2026.

“Topline data readout for our Halneuron® Phase 2b trial is on track for this fall, a potentially transformative moment for the care of CINP patients as well as Dogwood,” said Greg Duncan, Chief Executive Officer of Dogwood Therapeutics. “Halneuron® has demonstrated statistically significant and durable pain reduction in the clinical data developed to date, with an acceptable safety profile. Interim results from the on-going Phase 2b trial demonstrated Halneuron® treatment separating from placebo in terms of pain improvement. We anticipate enrolling over 220 patients to provide 80+% statistical power to support a clinically significant pain reduction effect when we report our results this fall,” Mr. Duncan continued. “If successful, we believe Halneuron® could represent the first new therapeutic agent for treating CINP, a condition for which there are currently no approved therapies.”  

Key Highlights

The Company currently has enrolled 217 patients in its Halneuron® Phase 2b Chemotherapy Induced Neuropathic Pain (“CINP”) study, with top-line results readout expected in the fall of 2026.
SP16 granted IND approval from the FDA. Study to begin enrolling in the second-half of 2026 for the treatment of chemotherapy induced pain and peripheral neuropathy (“CIPPN”). The study is fully funded by the National Cancer Institute and will be conducted at the University of Virginia.
Dogwood commences Phase 2b long-term extension study to assess Halneuron®’s reduction in pain over three months of treatment. 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.
The Company appointed Iain Dukes, D.Phil., Venture Partner at OrbiMed, as Chair of its Scientific Advisory Board.

1


Graphic

Cash on hand of $9.6 million provides operational runway through the Phase 2b readout in the fourth quarter of 2026.

Second Quarter 2026 Financial Results

Research and development expenses for the second quarter of 2026 were $3.2 million, compared to $2.6 million for the second quarter of 2025. The $0.6 million increase quarter over quarter primarily related to an increase in the Halneuron® Phase 2b CINP study costs of $0.7 million offset by a decrease in drug development and manufacturing costs of $0.1 million.

General and administrative expenses for the second quarter of 2026 were $1.6 million, compared to $1.3 million for the second quarter of 2025.  The $0.3 million increase quarter over quarter was primarily due to increases in salaries and related personnel costs of $0.3 million and an increase in franchise fees of $0.1 million offset by a decrease in public company costs of $0.1 million.

During the first and second quarter of 2026, the Company experienced a decline in its stock price resulting in market capitalization being less than stockholders’ equity, which management concluded was an impairment indicator. As a result, the Company performed a quantitative assessment for goodwill and IPR&D impairment and recognized a net non-cash impairment charge of $6.7 million.  This IPR&D impairment, which has no bearing on the Company’s cash runway, is comprised of a $9.2 million non-cash expense in the second quarter of 2026 which was partially offset by a reduction in the Company’s deferred tax liability expense of $2.5 million.

Net loss attributable to common stockholders for the second quarter of 2026 was $11.5 million, or $0.34 basic and diluted net loss per share, compared to a net loss attributable to common stockholders of $3.8 million, or $1.99 basic and diluted net loss per share, for the second 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. Dogwood’s 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.  

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Graphic

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.

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-

3


Graphic

DOGWOOD THERAPEUTICS

Selected Financial Data

(unaudited)

Condensed Statements of

Operations Data

Three Months Ended

June 30,

Six Months Ended

June 30,

2026

2025

2026

2025

Revenue

$

$

$

$

Operating expenses:

Research and development

3,246,519

2,569,943

5,916,298

5,006,941

General and administrative

1,626,109

1,353,172

4,032,696

3,346,100

IPR&D impairment

9,190,897

9,190,897

Total operating expenses

14,063,525

3,923,115

19,139,891

8,353,041

Loss from operations

(14,063,525

)

(3,923,115

)

(19,139,891

)

(8,353,041

)

Other income (expense):

Sublease income

17,442

36,897

Loss on debt conversion with related party

(6,134,120

)

Interest income (expense), net

66,349

111,379

143,699

(35,711

)

Exchange (loss) gain, net

(30,569

)

4,532

(36,429

)

(18,742

)

Total other income (expense), net

53,222

115,911

144,167

(6,188,573

)

Loss before income taxes

(14,010,303

)

(3,807,204

)

(18,995,724

)

(14,541,614

)

Deferred income tax benefit (expense)

2,480,694

(149

)

2,479,501

(190,691

)

Net Loss

(11,529,609

)

(3,807,353

)

(16,516,223

)

(14,732,305

)

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

(1,256,662

)

Net loss attributable to common stockholders

$

(11,529,609

)

$

(3,807,353

)

$

(16,516,223

)

$

(15,988,967

)

Net loss per share of common stock — basic and diluted

$

(0.34

)

$

(1.99

)

$

(0.49

)

$

(9.51

)

Weighted average shares outstanding — basic and diluted

34,129,553

1,911,128

33,838,766

1,680,827

   

4


Graphic

Condensed Consolidated Balance Sheet Data

June 30,

December 31,

2026

2025

Cash

$

9,610,033

$

6,524,744

Total assets

80,495,480

90,171,237

Total liabilities

12,129,372

15,274,370

Total stockholders’ equity

68,366,108

74,896,867

Source: Dogwood Therapeutics, Inc.

5


Filing Exhibits & Attachments

4 documents