Dogwood Therapeutics Announces Fourth Quarter and Full Year 2024 Financial Results

Rhea-AI Summary

Dogwood Therapeutics (NASDAQ: DWTX) has reported its Q4 and full-year 2024 financial results, highlighting significant developments in its pipeline. The company has begun dosing patients in the Halneuron® Phase 2b trial for Chemotherapy Induced Neuropathic Pain (CINP), with interim data expected in Q4 2025.

Financial highlights include a $19.5M debt-to-equity conversion by major shareholder CK Life Sciences, and a $4.8M common stock raise, extending operational runway through Q1 2026. The company reported a Q4 2024 net loss of $8.2M ($6.29 per share) compared to $1.1M in Q4 2023. Full-year 2024 net loss was $12.9M ($12.52 per share).

R&D expenses increased to $2.3M in Q4 2024 from $0.3M in Q4 2023, while G&A expenses rose to $5.2M from $0.8M. Cash position stands at $14.8M as of December 31, 2024.

Positive

• Debt-to-equity conversion of $19.5M strengthens balance sheet
• Successful $4.8M capital raise extends runway through Q1 2026
• FDA Fast Track designation granted for Halneuron in CINP treatment
• Phase 2b trial for Halneuron commenced with interim data expected Q4 2025

Negative

• Net loss increased to $8.2M in Q4 2024 vs $1.1M in Q4 2023
• R&D expenses increased significantly to $2.3M from $0.3M YoY
• G&A expenses rose substantially to $5.2M from $0.8M YoY
• Full-year net loss widened to $12.9M from $5.3M in 2023

Insights

Biotech Analyst

Dogwood Therapeutics' Q4 and FY2024 results reflect a company making meaningful clinical progress while stabilizing its financial foundation. The initiation of the Phase 2b trial for Halneuron in Chemotherapy Induced Neuropathic Pain (CINP) represents a critical advancement for their lead asset, which importantly has FDA Fast Track designation and targets an indication with no approved therapies.

The expected interim data readout in Q4 2025 creates a significant near-term catalyst that could validate their platform technology. Their pipeline diversity—with three clinical-stage assets targeting different indications (CINP, Long-COVID, and Fibromyalgia)—provides multiple potential paths to value creation and risk mitigation through program diversification.

While R&D expenses increased substantially year-over-year (767% in Q4), this reflects appropriate investment in clinical development rather than a concern. The $19.5 million debt-to-equity conversion by CK Life Sciences signals strong major shareholder confidence in the company's direction and substantially improves the balance sheet. Combined with the recent $4.8 million capital raise, Dogwood now has operational runway through Q1 2026, which should cover their key interim data readout.

This strategic restructuring positions Dogwood to potentially attract partnership interest for their secondary assets (IMC-1 and IMC-2) while maintaining focus on advancing their lead program. The overall progress demonstrates clinical and financial execution that strengthens their competitive position in the non-opioid pain management space.

Financial Analyst

Dogwood's financial results show a company in transition with both opportunities and challenges. Net losses widened to $8.2 million in Q4 2024 (645% increase YoY) and $12.9 million for the full year (143% increase YoY), primarily driven by clinical trial advancement and $3.9 million in non-recurring transaction costs related to the Pharmagesic combination.

The financial restructuring, however, represents a significant positive development. The conversion of $19.5 million in debt to equity eliminates interest expenses and removes debt overhang that would have constrained future flexibility. This balance sheet transformation, coupled with the $4.8 million capital raise, creates a $14.8 million cash position that management believes provides runway through Q1 2026—covering their critical interim data readout.

The expense increases appear strategic rather than operational inefficiency. R&D investment grew to $2.3 million for Q4 (667% increase YoY) as the company advances its lead program. The $5.2 million G&A expense (550% increase YoY) is distorted by the $3.9 million in non-recurring transaction costs.

From a cash burn perspective, the current position appears adequately aligned with their near-term clinical milestones. Looking forward, if Halneuron's interim data is positive in Q4 2025, Dogwood will likely need to pursue partnership deals or additional capital raises for the planned Phase 3 trials, but they've positioned themselves with multiple assets that could attract external funding or partnerships. The deliberate approach to seeking partnerships for secondary assets demonstrates financial discipline while maintaining focus on their lead program.

-Dogwood Therapeutics, Inc. commenced dosing of patients in the Halneuron^® Chemotherapy Induced Neuropathic Pain (“CINP”) Phase 2b Trial -

- Halneuron^® CINP P2b study interim data readout is expected in Q4 2025 -

- Conversion of existing $19.5M in debt to equity, strengthens balance sheet moving forward -

- Capital raise provides operational runway through Q1 2026 -

ATLANTA, March 31, 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 fourth quarter and full year ended December 31, 2024.

“We have made considerable progress in advancing our flagship Halneuron^® CINP Phase 2b study, with interim data expected by year end. We have also significantly improved our balance sheet and liquidity over the past few months, improving our cash position in a recent capital raise along with the agreement of our largest shareholder to exchange all their outstanding loan amounts for equity,” said Greg Duncan, Chief Executive Officer of Dogwood Therapeutics. “We believe this substantial organizational progress, in the context of future milestones, positions Dogwood as a more attractive investment opportunity moving forward.”

Key Highlights        

• The Company commenced dosing in its Halneuron^® Phase 2b CINP program this month, with potential to be the first FDA approved therapy for the treatment of CINP.
• Based on its conviction in Halneuron^® and the Dogwood Therapeutics management team’s ability to execute, the Company’s largest shareholder, CK Life Sciences (Holdings) Int’l, converted through an affiliate their outstanding $19.5 million loan to equity, improving the Company’s balance sheet.
• Recent $4.8 million common stock capital raise, combined with existing cash, provides the Company with operational runway through the first quarter of 2026.
  

Dogwood Therapeutics Proprietary Pipeline Includes:

• Halneuron^® is in Phase 2b development as a non-opioid, Na_V 1.7 inhibitor to treat 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. 
  
  Next milestone: Interim data from the ongoing Phase 2b CINP study are expected in Q4 2025.

• IMC-2 (valacyclovir + celecoxib) is in Phase 2a development as a combination antiviral treatment for Long-COVID.
  
  Next milestone: Dogwood is simultaneously exploring external funding and/or a partnership to advance IMC-2 into Phase 2b development as a treatment for Long-COVID.

• 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.
  
  Next milestone: Dogwood is exploring partnerships for IMC-1 to execute the Phase 3 FM program agreed upon by the FDA and will provide an update in Q2 of this year.

Fourth Quarter 2024 Financial Results

Research and development expenses for the fourth quarter of 2024 were $2.3 million, compared to $0.3 million for the fourth quarter of 2023. The $2.0 million increase quarter over quarter was due to increases in expenses for clinical trials of $1.1 million, drug development and manufacturing costs of $0.6 million and salaries and related personnel costs of $0.3 million.

General and administrative expenses for the fourth quarter of 2024 were $5.2 million, compared to $0.8 million for the fourth quarter of 2023. The $4.4 million increase quarter over quarter was primarily due to nonrecurring transaction costs of $3.9 million related to the combination of Pharmagesic in October 2024 and an increase in salaries and related personnel costs of $0.5 million.

Net loss attributable to common stockholders for the fourth quarter of 2024 was $8.2 million, or $6.29 basic and diluted net loss per share, compared to a net loss attributable to common stockholders of $1.1 million, or $1.43 basic and diluted net loss per share, for the fourth quarter of 2023.

Full Year 2024 Financial Results

Research and development expenses for the year ended December 31, 2024 were $3.5 million, compared to $1.7 million for the year ended December 31, 2023. The $1.8 million increase was primarily due to increases in expenses for clinical trials of $1.0 million, research and preclinical activities of $0.3 million, drug development and manufacturing costs of $0.4 million, and salaries and related personnel costs of $0.3 million partially offset by a decrease in regulatory consulting of $0.2 million.

General and administrative expenses for the year ended December 31, 2024 were $8.7 million, compared to $3.7 million for the year ended December 31, 2023. The $5.0 million increase was primarily due to nonrecurring transaction costs of $4.9 million related to the combination of Pharmagesic in October 2024, an increase in salaries and related personnel costs of $0.4 million partially offset by a decrease of $0.3 million related to insurance costs associated with being a public company.

Net loss attributable to common stockholders for the year ended December 31, 2024 was $12.9 million, or $12.52 basic and diluted net loss per share, compared to a net loss attributable to common stockholders of $5.3 million, or $7.05 basic and diluted net loss per share, for the year ended December 31, 2023.

As of December 31, 2024, Dogwood Therapeutics’ cash totaled $14.8 million. The Company believes it has sufficient resources to fund operations through the first quarter of 2026.

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 Amended Annual Report on Form 10-K/A for the year ended December 31, 2023 and the Company’s quarterly report on Form 10-Q for the quarterly period ended September 30, 2024, which are 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 Consolidated		Three Months Ended								Year Ended
Statements of Operations Data		December 31,								December 31,
		2024				2023				2024				2023
Revenue		$	—			$	—			$	—			$	—
Operating expenses:
Research and development			2,315,950				298,320				3,530,913				1,728,078
General and administrative			5,226,202				839,806				8,696,335				3,718,841
Total operating expenses			7,542,152				1,138,126				12,227,248				5,446,919
Loss from operations			(7,542,152	)			(1,138,126	)			(12,227,248	)			(5,446,919	)
Other (expense) income:
Interest (expense) income, net			(155,436	)			34,953				(92,192	)			150,904
Exchange loss, net			(30,787	)			—				(30,787	)			—
Total other (expense) income, net			(186,223	)			34,953				(122,979	)			150,904
Loss before income taxes			(7,728,375	)			(1,103,173	)			(12,350,227	)			(5,296,015	)
Deferred income tax provision			503				—				503				—
Net Loss			(7,727,872	)			(1,103,173	)			(12,349,724	)			(5,296,015	)
Accrual of paid-in-kind dividends on
Series A non-voting convertible
preferred stock			(514,105	)			—				(514,105	)			—
Net loss attributable to common
stockholders		$	(8,241,977	)		$	(1,103,173	)		$	(12,863,829	)		$	(5,296,015	)
Net loss per share of common stock —
basic and diluted, as adjusted		$	(6.29	)		$	(1.43	)		$	(12.52	)		$	(7.05	)
Weighted average shares outstanding
— basic and diluted, as adjusted			1,310,474				770,317				1,027,788				751,071

Condensed Consolidated Balance Sheet Data	December 31,				December 31,
	2024				2023
Cash	$	14,847,949			$	3,316,946
Total assets		94,308,246				4,165,442
Total liabilities		30,027,223				358,548
Total stockholders’ (deficit) equity		(10,124,339	)			3,806,894

Source: Dogwood Therapeutics, Inc.

FAQ

What is the expected timeline for Halneuron CINP Phase 2b trial interim data for DWTX?

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

How much debt did DWTX convert to equity in 2024?

CK Life Sciences converted $19.5 million of outstanding loan to equity.

What was Dogwood Therapeutics' (DWTX) net loss per share in Q4 2024?

DWTX reported a net loss of $6.29 per share in Q4 2024.

How long will DWTX's current cash runway last?

The company's current cash position is expected to fund operations through Q1 2026.

What was DWTX's cash position at the end of 2024?

Dogwood Therapeutics had $14.8 million in cash as of December 31, 2024.