Form 8-K
8-K — Dogwood Therapeutics, Inc.
Accession: 0001104659-26-060747
Filed: 2026-05-14
Period: 2026-05-14
CIK: 0001818844
SIC: 2834 (PHARMACEUTICAL PREPARATIONS)
Item: Results of Operations and Financial Condition
Item: Financial Statements and Exhibits
Documents
8-K — dwtx-20260514x8k.htm (Primary)
EX-99.1 (dwtx-20260514xex99d1.htm)
GRAPHIC (dwtx-20260514xex99d1001.jpg)
XML — IDEA: XBRL DOCUMENT (R1.htm)
8-K
8-K (Primary)
Filename: dwtx-20260514x8k.htm · Sequence: 1
DOGWOOD THERAPEUTICS, INC._May 14, 2026
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
3
EX-99.1
EX-99.1
Filename: dwtx-20260514xex99d1.htm · Sequence: 2
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
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.
2
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
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
4
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
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