Dogwood Therapeutics Reports Second Quarter 2025 Financial Results

Rhea-AI Summary

Dogwood Therapeutics (NASDAQ:DWTX) has reported its Q2 2025 financial results, highlighting progress in its Halneuron® Phase 2b trial for Chemotherapy-Induced Neuropathic Pain (CINP). The company has enrolled 52 patients with a low discontinuation rate of 5.8%, suggesting good tolerability. The interim data readout remains on track for Q4 2025.

The company's pipeline includes Halneuron®, which has received FDA fast track designation for CINP treatment, and IMC-1 for Fibromyalgia. Financial results show R&D expenses of $2.5 million and a net loss of $3.8 million. With $13.4 million cash on hand, Dogwood has operational runway through Q1 2026.

Positive

• Low discontinuation rate of 5.8% in Halneuron® trial indicates good tolerability
• FDA fast track designation received for Halneuron® in CINP treatment
• Potential to be first FDA-approved therapy for CINP treatment
• Cash runway extends through Q1 2026

Negative

• Net loss increased to $3.8 million from $1.0 million year-over-year
• R&D expenses significantly increased to $2.5 million from $0.3 million year-over-year
• Paused Long-COVID research due to government funding uncertainty

Insights

Biotechnology Research Analyst

Dogwood's Q2 results show promising Halneuron trial progress with $13.4M cash runway through Q1 2026, while losses widened to $3.8M.

Dogwood Therapeutics is advancing a potentially significant first-in-class therapy for a currently untreated condition. The company has enrolled 52 patients in its Phase 2b trial for Halneuron, targeting chemotherapy-induced neuropathic pain (CINP) - an area with zero FDA-approved treatments currently. The low discontinuation rate of 5.8% suggests the drug is being well-tolerated, a crucial early indicator for pain medications where side effects often limit clinical utility.

The company's financial position reveals both opportunities and challenges. With $13.4 million cash on hand providing runway through Q1 2026, Dogwood has sufficient capital to reach its next major catalyst - the interim data readout expected in Q4 2025. However, quarterly R&D expenses have increased substantially to $2.5 million from $0.3 million year-over-year, primarily due to the Halneuron clinical program. Net losses widened to $3.8 million ($1.99 per share) versus $1.0 million ($1.15 per share) in Q2 2024.

The strategic pause on the Long-COVID program (IMC-2) due to uncertain government funding signals prudent capital allocation, allowing focus on the more advanced Halneuron program with FDA fast track designation. Targeting the NaV 1.7 sodium channel represents a differentiated mechanism with scientific rationale, as genetic evidence from Congenital Insensitivity to Pain Syndrome validates this pathway's critical role in pain signaling. The company's platform potential across multiple pain indications (diabetic peripheral neuropathy, post-herpetic neuralgia, acute surgical pain) could substantially expand the market opportunity beyond CINP if the core mechanism proves successful.

Financial Analyst

Dogwood's Q2 results reflect the typical financial profile of an early clinical-stage biotech with promising assets but increasing cash burn. The $13.4 million cash position provides runway only through Q1 2026, which offers a tight timeline to reach the upcoming Q4 2025 interim data readout for their lead Halneuron program but may require additional funding before potentially advancing to Phase 3.

The quarterly financial metrics reveal substantial growth in operational expenses, with R&D increasing by 733% year-over-year to $2.5 million and G&A rising by 86% to $1.3 million. This escalation stems largely from the business combination with Pharmagesic and expanded clinical activities. The net loss widened to $3.8 million ($1.99 per share) from $1.0 million ($1.15 per share) in Q2 2024, indicating an accelerating cash burn rate that bears monitoring.

Strategic prioritization is evident in the decision to pause the Long-COVID program pending government funding clarity, allowing resources to be concentrated on the more advanced Halneuron CINP trial. The company has secured FDA fast track designation for both Halneuron and IMC-1, potentially expediting review timelines and creating value inflection points. As a first-mover in the CINP space, commercial potential exists if efficacy is demonstrated, though the narrow cash runway suggests potential dilutive financing before reaching commercialization. The upcoming Q4 2025 interim data represents a crucial catalyst that could significantly impact Dogwood's valuation and ability to raise additional capital on favorable terms.

- Enrollment to-date of 52 patients in the ongoing Halneuron^® Phase 2b Trial -

- Halneuron^® Chemotherapy-Induced Neuropathic Pain (“CINP”) Phase 2b study interim data readout remains on track for Q4 2025 -

- Low discontinuation rate (5.8%) due to adverse events in the first 38 patients completing the trial suggests Halneuron^® and placebo treatment have been generally well tolerated -

- Cash on hand of $13.4 million provides operational runway through Q1 2026 -

ATLANTA, Aug. 13, 2025 (GLOBE NEWSWIRE) -- Dogwood Therapeutics, Inc. (Nasdaq: DWTX) (the “Company”), a development-stage biotechnology company developing new medicines to treat pain and fatigue-related disorders, today announced financial results for the second quarter ended June 30, 2025.

“With no FDA approved treatments to manage the neuropathic pain often resulting from chemotherapy treatment, we have the opportunity to potentially enjoy the benefits of being the first and only approved CINP treatment,” said Greg Duncan, Chief Executive Officer of Dogwood Therapeutics. “Further, we believe Halneuron’s^® clinically significant effects in treating both general cancer pain and chemotherapy induced neuropathic pain highlights the significant potential to expand our Na_V 1.7 research pipeline to other forms of pain, including diabetic peripheral neuropathy, post herpetic neuralgia and acute surgical pain.”   

“The Na_V 1.7 sodium channel plays a fundamental role in pain transmission, so modulation of this pathway is likely to be applicable to the treatment of both chronic and acute pain states” said Michael Gendreau, MD, PhD, Chief Medical Officer of Dogwood Therapeutics. “A genetic lack of functioning Na_V 1.7 channels leads to a condition known as Congenital Insensitivity to Pain Syndrome, a disorder characterized by the inability to feel pain. Patients who suffer from this condition illustrate the critical role Na_V 1.7 function represents as a pain treatment target.”   

Key Highlights        

• To-date, the Company has enrolled 52 patients in its ongoing Halneuron^® Phase 2b CINP program this quarter, with potential to be the first FDA approved therapy for the treatment of CINP.
  

Dogwood Therapeutics Proprietary Pipeline Includes:

• Halneuron^® is in Phase 2b development as a non-opioid, Na_V 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.   Interim data from the ongoing Phase 2b CINP study are expected in Q4 2025.
• IMC-1 (famciclovir + celecoxib) is ready for Phase 3 development as a combination antiviral treatment for Fibromyalgia (“FM”). IMC-1 has been granted fast track designation by the FDA for the treatment of FM.
• IMC-2 (valacyclovir + celecoxib) is in Phase 2a development as a combination antiviral treatment for Long-COVID. Given the importance of Health and Human Services and Medicaid and Medicare funding of both COVID research and reimbursement of treatment, pervasive reductions in government health funding have resulted in us pausing current external research funding and partnership discussions until we have greater clarity on the commitment of U.S. Government resources to COVID illness.
  

Second Quarter 2025 Financial Results

Research and development expenses for the second quarter of 2025 were $2.5 million, compared to $0.3 million for the second quarter of 2024. The $2.2 million increase quarter over quarter was primarily due to the impact of the business combination with Pharmagesic (the “Combination”) including increases in expenses for clinical trials of $1.6 million related to the Halneuron^® CINP Phase 2b study, as well as drug development and manufacturing costs of $0.5 million and salaries and related personnel costs of $0.2 million, offset by a decrease in regulatory costs of $0.1 million.

General and administrative expenses for the second quarter of 2025 were $1.3 million, compared to $0.7 million for the second quarter of 2024. The $0.6 million increase quarter over quarter was primarily due to increases in legal and accounting fees of $0.2 million, salaries and related personnel costs of $0.2 million, expenses associated with being a public company of $0.1 million and other general and administrative costs of $0.1 million.

Net loss attributable to common stockholders for the second quarter of 2025 was $3.8 million, or $1.99 basic and diluted net loss per share, compared to a net loss attributable to common stockholders of $1.0 million, or $1.15 basic and diluted net loss per share, for the second quarter of 2024.

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 IMC-2 LC 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

-Financial Tables Follow-

DOGWOOD THERAPEUTICS Selected Financial Data          (unaudited)
Condensed Statements of Operations Data	Three Months Ended June 30,									Six Months Ended June 30,
	2025				2024					2025				2024
Revenue	$	—			$		—			$	—			$	—
Operating expenses:
Research and development		2,569,943					336,084				5,006,941				679,801
General and administrative		1,353,172					733,740				3,346,100				1,704,124
Total operating expenses		3,923,115					1,069,824				8,353,041				2,383,925
Loss from operations		(3,923,115	)				(1,069,824	)			(8,353,041	)			(2,383,925	)
Other (expense) income:
Loss on debt conversion with related party		—					—				(6,134,120	)			—
Interest income (expense), net		111,379					19,991				(35,711	)			42,757
Exchange gain (loss), net		4,532					—				(18,742	)			—
Total other income (expense), net		115,911					19,991				(6,188,573	)			42,757
Loss before income taxes		(3,807,204	)				(1,049,833	)			(14,541,614	)			(2,341,168	)
Deferred income tax provision		(149	)				—				(190,691	)			—
Net Loss		(3,807,353	)				(1,049,833	)			(14,732,305	)			(2,341,168	)
Accrual of paid-in-kind dividends on Series A non-voting convertible preferred stock		—					—				(1,256,662	)			—
Net loss attributable to common stockholders	$	(3,807,353	)		$		(1,049,833	)		$	(15,988,967	)		$	(2,341,168	)
Net loss per share of common stock — basic and diluted	$	(1.99	)		$		(1.15	)		$	(9.51	)		$	(2.78	)
Weighted average shares outstanding — basic and diluted		1,911,128					916,031				1,680,827				843,174

Condensed Consolidated Balance Sheet Data	June 30,				December 31,
	2025				2024
Cash	$	13,402,809			$	14,847,949
Total assets		96,692,527				94,308,246
Total liabilities		14,151,904				30,027,223
Total stockholders’ equity (deficit)		6,878,599				(10,124,339	)

Source: Dogwood Therapeutics, Inc.

FAQ

What were Dogwood Therapeutics (DWTX) Q2 2025 financial results?

Dogwood reported a net loss of $3.8 million ($1.99 per share), R&D expenses of $2.5 million, and cash position of $13.4 million providing runway through Q1 2026.

How many patients are enrolled in Dogwood's Halneuron Phase 2b CINP trial?

52 patients have been enrolled in the ongoing Halneuron® Phase 2b trial for Chemotherapy-Induced Neuropathic Pain, with a low discontinuation rate of 5.8%.

When will Dogwood Therapeutics (DWTX) release Halneuron Phase 2b interim data?

Dogwood expects to release the interim data from the Phase 2b CINP study in Q4 2025.

What is the status of Dogwood Therapeutics' IMC-2 Long-COVID program?

Dogwood has paused external research funding and partnership discussions for the IMC-2 Long-COVID program due to uncertainty in U.S. Government health funding.

What potential market advantage does Halneuron have for CINP treatment?

Halneuron has the potential to be the first and only FDA-approved treatment for chemotherapy-induced neuropathic pain, as there are currently no approved treatments.