Dogwood Therapeutics, Inc. Receives Nasdaq Confirmation of Compliance

Rhea-AI Summary

Dogwood Therapeutics (DWTX) has successfully regained compliance with Nasdaq's minimum stockholders' equity requirement of $2.5 million, following a notification of non-compliance received on November 15, 2024. The company submitted a compliance plan on December 27, 2024, and was granted until May 14, 2025, to meet the requirement.

The biopharmaceutical company, focused on developing medicines for pain and fatigue-related disorders, reports a strong cash position of $17.5 million as of Q1. DWTX is currently conducting a Phase 2b trial for Halneuron® in Chemotherapy Induced Neuropathic Pain, with interim data analysis planned for Q4 2025.

Positive

• Regained Nasdaq compliance, eliminating delisting risk
• Strong cash position of $17.5 million in Q1 2025
• Phase 2b trial for Halneuron progressing with interim data expected in Q4 2025

Negative

• Previously fell below minimum stockholders' equity requirement, indicating financial challenges

ATLANTA, April 11, 2025 (GLOBE NEWSWIRE) -- Dogwood Therapeutics, Inc. (Nasdaq: DWTX) (the “Company”), a development-stage biopharmaceutical company focused on developing new medicines to treat pain and fatigue-related disorders, today announced that it has received written confirmation from Nasdaq that it has regained compliance with Nasdaq Listing Rule 5550(b)(1), which requires minimum stockholders’ equity of $2.5 million.

DWTX Chairman and CEO Greg Duncan stated, “We are pleased that the Company successfully implemented a plan to regain compliance and meet the equity requirement and is continuing to execute that plan going forward.” He continued, “The Company has a strong cash position of $17.5 million as of the end of Q1, and we are dosing patients in our Halneuron^® Phase 2b Chemotherapy Induced Neuropathic Pain Trial to support our planned interim data analysis in the fourth quarter this year.”

As previously disclosed, the Company received a letter on November 15, 2024 notifying the Company that its amount of stockholders’ equity had fallen below the $2.5 million minimum stockholders’ equity requirement (the “Minimum Equity Requirement”). On December 27, 2024, it submitted to Nasdaq a plan of compliance to achieve and sustain compliance with the Minimum Equity Requirement. On February 2, 2025, the Company received a letter from Nasdaq granting it until May 14, 2025 to regain compliance with the Nasdaq Listing Rule 5550(b)(1). On April 8, 2025, the Company received a letter from Nasdaq stating that based on its Form 8-K, dated April 3, 2025, Staff has determined that the Company complies with the Listing Rule 5550(b)(1).

About Dogwood Therapeutics

Dogwood Therapeutics (Nasdaq: DWTX) is a development-stage biopharmaceutical company focused on developing new medicines to treat pain and fatigue-related disorders. The Dogwood research pipeline includes two separate mechanistic platforms with a non-opioid analgesic program and an antiviral program. The proprietary, non-opioid, Na_V 1.7 analgesic program is centered on our lead development candidate, Halneuron^®, 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”). Interim data from the ongoing Halneuron^® Phase 2 CINP study are expected in Q4 of 2025.

Dogwood’s antiviral program includes IMC-1 and IMC-2, which are novel, proprietary, fixed-dose combinations of anti-herpes antivirals and the anti-inflammatory agent celecoxib. These combination antiviral approaches are being applied to the treatment of illnesses believed to be related to reactivation of previously dormant herpesviruses, including fibromyalgia (“FM”) and Long-COVID (“LC”). IMC-1 is poised to progress into Phase 3 development as a treatment for FM and is the focus of external partnership activities. IMC-2 has been assessed in both active control and double-blind, placebo-controlled clinical trials and, in both cases, demonstrated successful reduction of the fatigue associated with LC. The company has reached an agreement with FDA on using reduction in fatigue as the primary endpoint for future LC research and is currently planning to advance IMC-2 into Phase 2b research.

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

FAQ

What was the minimum stockholders' equity requirement DWTX needed to meet for Nasdaq compliance?

DWTX needed to maintain a minimum stockholders' equity of $2.5 million to comply with Nasdaq Listing Rule 5550(b)(1).

How much cash does Dogwood Therapeutics (DWTX) have on hand in Q1 2025?

DWTX reported a cash position of $17.5 million as of the end of Q1 2025.

When will DWTX release interim data for their Halneuron Phase 2b trial?

DWTX plans to release interim data analysis from the Halneuron Phase 2b trial in the fourth quarter of 2025.

What condition is DWTX's Halneuron being tested for in the Phase 2b trial?

Halneuron is being tested for Chemotherapy Induced Neuropathic Pain in the Phase 2b trial.