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Dogwood Therapeutics Announces油First Quarter 2025 Financial Results

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Dogwood Therapeutics (DWTX) reported Q1 2025 financial results and key developments. The company has begun dosing patients in its Halneuron速 Phase 2b study for Chemotherapy Induced Neuropathic Pain (CINP), with interim data expected in Q4 2025. The company's financial position includes $17.5M cash on hand, providing runway through Q1 2026, bolstered by a $4.8M stock raise and conversion of a $19.5M loan to equity by CK Life Sciences. Q1 2025 saw increased R&D expenses of $2.4M (up from $0.3M in Q1 2024) and G&A expenses of $2.0M (up from $1.0M). The net loss was $12.2M or $8.45 per share. The company regained Nasdaq compliance and maintains FDA fast track designation for Halneuron速 in CINP treatment.
Dogwood Therapeutics (DWTX) ha riportato i risultati finanziari del primo trimestre 2025 e gli sviluppi chiave. L'azienda ha iniziato a somministrare il farmaco ai pazienti nello studio di Fase 2b di Halneuron速 per il dolore neuropatico indotto dalla chemioterapia (CINP), con dati intermedi attesi nel quarto trimestre 2025. La posizione finanziaria dell'azienda include 17,5 milioni di dollari in liquidit, garantendo risorse fino al primo trimestre 2026, supportata da un aumento di capitale di 4,8 milioni di dollari e dalla conversione di un prestito da 19,5 milioni di dollari in equity da parte di CK Life Sciences. Nel primo trimestre 2025, le spese per ricerca e sviluppo sono aumentate a 2,4 milioni di dollari (rispetto a 0,3 milioni nel primo trimestre 2024) e le spese generali e amministrative a 2,0 milioni di dollari (rispetto a 1,0 milione). La perdita netta 竪 stata di 12,2 milioni di dollari, pari a 8,45 dollari per azione. L'azienda ha riconquistato la conformit Nasdaq e mantiene la designazione FDA fast track per Halneuron速 nel trattamento del CINP.
Dogwood Therapeutics (DWTX) inform坦 los resultados financieros del primer trimestre de 2025 y los desarrollos clave. La compa単鱈a ha comenzado a administrar dosis a los pacientes en su estudio de fase 2b de Halneuron速 para el dolor neurop叩tico inducido por quimioterapia (CINP), con datos intermedios esperados para el cuarto trimestre de 2025. La posici坦n financiera de la empresa incluye 17,5 millones de d坦lares en efectivo, lo que proporciona recursos hasta el primer trimestre de 2026, reforzado por una emisi坦n de acciones de 4,8 millones de d坦lares y la conversi坦n de un pr辿stamo de 19,5 millones de d坦lares en acciones por parte de CK Life Sciences. En el primer trimestre de 2025, los gastos en I+D aumentaron a 2,4 millones de d坦lares (desde 0,3 millones en el primer trimestre de 2024) y los gastos generales y administrativos a 2,0 millones de d坦lares (desde 1,0 mill坦n). La p辿rdida neta fue de 12,2 millones de d坦lares, o 8,45 d坦lares por acci坦n. La compa単鱈a recuper坦 el cumplimiento con Nasdaq y mantiene la designaci坦n de v鱈a r叩pida de la FDA para Halneuron速 en el tratamiento de CINP.
Dogwood Therapeutics(DWTX)� 2025� 1覿蠍 覓 蟆郁骸 譯殊 螳覦 � 覦給. � 覯 覦 蟆暑讀� 旧(CINP) 豺襭襯� Halneuron速 2b� 曙� 朱�, 譴螳 一危磯 2025� 4覿蠍一� 覦� �. � 覓 � 1,750襷� � 蠍 覲伎襦� 2026� 1覿蠍郁讌 伎 蠍� 覲危朱�, 480襷� � 譯殊 覦螻� CK Life Sciences螳 1,950襷� 豢 譯殊朱 � 覿� 覓 蠍磯� 螳給�. 2025� 1覿蠍 郁規螳覦觜 240襷� 襦� 2024� 1覿蠍 30襷� 讀螳螻, 朱蟯襴觜� 200襷� 襦� 100襷� 麹給. れ 1,220襷� , 譯朱 れ 8.45給�. � る� 蠏� 豢譟燕朱 CINP 豺襭襯� Halneuron速� FDA 讌 讌螻 給.
Dogwood Therapeutics (DWTX) a publi辿 ses r辿sultats financiers du premier trimestre 2025 ainsi que ses d辿veloppements cl辿s. La soci辿t辿 a commenc辿 administrer des doses aux patients dans son 辿tude de phase 2b de Halneuron速 pour la douleur neuropathique induite par la chimioth辿rapie (CINP), avec des donn辿es interm辿diaires attendues au quatri竪me trimestre 2025. La situation financi竪re de l'entreprise comprend 17,5 millions de dollars de liquidit辿s, assurant une tr辿sorerie jusqu'au premier trimestre 2026, renforc辿e par une lev辿e de fonds de 4,8 millions de dollars et la conversion d'un pr棚t de 19,5 millions de dollars en actions par CK Life Sciences. Au premier trimestre 2025, les d辿penses de R&D ont augment辿 2,4 millions de dollars (contre 0,3 million au T1 2024) et les frais g辿n辿raux et administratifs 2,0 millions de dollars (contre 1,0 million). La perte nette s'est 辿lev辿e 12,2 millions de dollars, soit 8,45 dollars par action. La soci辿t辿 a retrouv辿 sa conformit辿 au Nasdaq et conserve la d辿signation de voie rapide FDA pour Halneuron速 dans le traitement du CINP.
Dogwood Therapeutics (DWTX) meldete die Finanzergebnisse und wichtige Entwicklungen f端r das erste Quartal 2025. Das Unternehmen hat mit der Dosierung von Patienten in seiner Halneuron速 Phase 2b-Studie zur Chemotherapie-induzierten neuropathischen Schmerzen (CINP) begonnen, wobei Zwischenberichte im vierten Quartal 2025 erwartet werden. Die finanzielle Lage umfasst 17,5 Mio. USD an verf端gbaren Barmitteln, die den Betrieb bis zum ersten Quartal 2026 sichern, gest端tzt durch eine Kapitalerh旦hung von 4,8 Mio. USD und die Umwandlung eines 19,5 Mio. USD Darlehens in Eigenkapital durch CK Life Sciences. Die F&E-Ausgaben stiegen im ersten Quartal 2025 auf 2,4 Mio. USD (gegen端ber 0,3 Mio. USD im ersten Quartal 2024) und die Verwaltungsaufwendungen auf 2,0 Mio. USD (gegen端ber 1,0 Mio. USD). Der Nettoverlust betrug 12,2 Mio. USD bzw. 8,45 USD pro Aktie. Das Unternehmen hat die Nasdaq-Compliance wiedererlangt und beh辰lt die FDA-Fast-Track-Status f端r Halneuron速 bei der Behandlung von CINP bei.
Positive
  • FDA fast track designation obtained for Halneuron速 in CINP treatment
  • Successful $4.8M capital raise strengthening cash position
  • $19.5M loan conversion to equity improving balance sheet
  • Regained Nasdaq compliance
  • Cash runway extended through Q1 2026
  • Pipeline includes multiple drug candidates in various development stages
Negative
  • Increased net loss to $12.2M in Q1 2025 from $1.3M in Q1 2024
  • R&D expenses increased significantly to $2.4M from $0.3M YoY
  • G&A expenses doubled to $2.0M from $1.0M YoY

Insights

Dogwood progresses Halneuron CINP trial with Fast Track status, addressing large unmet need amid increasing R&D investment.

Dogwood Therapeutics has commenced dosing in its Phase 2b trial for Halneuron in Chemotherapy Induced Neuropathic Pain (CINP), targeting a condition with no FDA-approved treatments. The scientific rationale behind this program is compelling - Halneuron inhibits the NaV 1.7 sodium channel, which plays a fundamental role in pain transmission. The genetic validation of this target is particularly strong, as evidenced by patients with Congenital Insensitivity to Pain Syndrome who lack functioning NaV 1.7 channels and cannot feel pain.

The company has secured Fast Track designation from the FDA for Halneuron in CINP, which could accelerate the regulatory timeline if clinical data proves positive. Additionally, Dogwood maintains a diversified pipeline with IMC-2 for Long-COVID in Phase 2a and IMC-1 for Fibromyalgia ready for Phase 3, the latter also having Fast Track designation.

The increase in R&D expenses to $2.4 million from $0.3 million year-over-year primarily reflects the operational ramp-up for the Halneuron CINP trial. This strategic investment in clinical development is appropriate given the significant unmet need in CINP. The planned interim data readout in Q4 2025 represents a critical milestone that could validate both the compound and the mechanism of action in this indication.

Mixed financial picture with improved balance sheet but accelerated cash burn; runway covers upcoming key data readout.

Dogwood Therapeutics' Q1 2025 financials present a complex picture. While R&D expenses increased significantly to $2.4 million (from $0.3 million in Q1 2024) and G&A costs doubled to $2.0 million, these increases were directly tied to clinical advancement and the business combination with Pharmagesic. The company reported a net loss of $12.2 million ($8.45 per share), substantially higher than the $1.3 million loss ($1.68 per share) in Q1 2024.

The balance sheet has been meaningfully strengthened through two key transactions: the conversion of a $19.5 million loan from their largest shareholder (CK Life Sciences affiliate) into equity, and a $4.8 million common stock capital raise. These actions have provided Dogwood with $17.5 million in cash, extending their operational runway through Q1 2026.

This timeline is strategically important as it ensures funding through their expected Q4 2025 interim data readout for the Halneuron CINP study. The company has also addressed regulatory concerns, regaining compliance with Nasdaq's minimum stockholders' equity requirement. The accelerated cash burn rate reflects their transition into a more active clinical development phase, which is necessary to advance their pipeline but will require careful financial management going forward.

- Dogwood Therapeutics, Inc. commenced dosing of patients in the Halneuron Chemotherapy Induced Neuropathic Pain Phase 2b Study -

- Halneuron Chemotherapy Induced Neuropathic Pain Phase 2b study interim data readout is expected in Q4 2025 -

- Cash on hand of $17.5M provides operational runway through Q1 2026 -

ATLANTA, May 08, 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 first quarter ended March 31, 2025.

There are no FDA approved treatments to manage the neuropathic pain often resulting from chemotherapy treatment,� said Greg Duncan, Chief Executive Officer of Dogwood Therapeutics. We believe Halneurons clinically significant effects in treating both general cancer pain and chemotherapy induced neuropathic pain highlights the great potential to expand our NaV 1.7 research pipeline to other forms of pain, including diabetic peripheral neuropathy, post herpetic neuralgia and potentially acute surgical pain as well.油�

The NaV 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.油 A genetic lack of functioning NaV 1.7 channels leads to a condition known as Congenital Insensitivity to Pain Syndrome, a disorder characterized by the inability to feel pain.油 Patients who suffer from this condition illustrate the critical role NaV 1.7 function represents as a pain treatment target.油�

Key Highlights

  • The Company commenced dosing in its Halneuron Phase 2b Chemotherapy Induced Neuropathic Pain (CINP�) program this quarter, with potential to be the first FDA approved therapy for the treatment of CINP.
  • An affiliate of the Companys largest shareholder, CK Life Sciences (Holdings) Intl, converted its outstanding $19.5 million loan into equity, improving the Companys balance sheet.
  • A recent $4.8 million gross common stock capital raise, combined with existing cash, provides the Company with operational runway through the first quarter of 2026.
  • The Company 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.


Dogwood Therapeutics Proprietary Pipeline Includes:

  • Halneuron is in Phase 2b 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.油 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.
  • 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.


First Quarter 2025 Financial Results

Research and development expenses for the first quarter of 2025 were $2.4 million, compared to $0.3 million for the first quarter of 2024. The $2.1 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 $1.8 million related to the Halneuron CINP Phase 2b study as well as drug development and manufacturing costs of $0.1 million and salaries and related personnel costs of $0.2 million.

General and administrative expenses for the first quarter of 2025 were $2.0 million, compared to $1.0 million for the first quarter of 2024.油 The $1.0 million increase quarter over quarter was primarily due to increases in legal and accounting fees of $0.6 million related to the Combination, franchise tax fees of $0.2 million, salaries and related personnel costs of $0.2 million and other general and administrative costs of $0.1 million offset by lower insurance expenses associated with being a public company of $0.1 million.

Net loss attributable to common stockholders for the first quarter of 2025 was $12.2 million, or $8.45 basic and diluted net loss per share, compared to a net loss attributable to common stockholders of $1.3 million, or $1.68 basic and diluted net loss per share, for the first 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, NaV油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油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油Phase 2 CINP study are expected in Q4 of 2025.

Dogwoods 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油.

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 Dogwoods 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 Dogwoods 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

-Financial Tables Follow-


DOGWOOD THERAPEUTICS
Selected Financial Data
(unaudited)油 油

Condensed Consolidated
Statements of Operations Data
Three Months Ended
March 31,

油2025油2024
Revenue$$
Operating expenses:
Research and development2,436,998343,717
General and administrative1,992,928970,384
Total operating expenses4,429,9261,314,101
Loss from operations(4,429,926)(1,314,101)
Other (expense) income:
Loss on debt conversion with related party(6,134,120)
Interest (expense) income, net(147,090)22,766
Exchange loss, net(23,274)
Total other (expense) income, net(6,304,484)22,766
Loss before income taxes(10,734,410)(1,291,335)
Deferred income tax provision(190,542)
Net Loss(10,924,852)(1,291,335)
Accrual of paid-in-kind dividends on Series A non-voting convertible preferred stock(1,256,662)
Net loss attributable to common stockholders$(12,181,614)$(1,291,335)
Net loss per share of common stock � basic and diluted, as adjusted$(8.45)$(1.68)
Weighted average shares outstanding � basic and diluted, as adjusted1,441,535770,317

Condensed Consolidated Balance Sheet DataMarch 31,December 31,
20252024
Cash$17,539,004$14,847,949
Total assets96,984,68894,308,246
Total liabilities14,235,73330,027,223
Total stockholders� equity (deficit)7,086,931(10,124,339)

Source: Dogwood Therapeutics, Inc.


FAQ

What were DWTX's key financial results for Q1 2025?

In Q1 2025, DWTX reported a net loss of $12.2M ($8.45 per share), R&D expenses of $2.4M, and G&A expenses of $2.0M. The company has $17.5M cash on hand, providing runway through Q1 2026.

What is the status of Dogwood Therapeutics' Halneuron速 development program?

Halneuron速 is currently in Phase 2b clinical trials for Chemotherapy Induced Neuropathic Pain (CINP), with patient dosing commenced and interim data expected in Q4 2025. The drug has received FDA fast track designation.

How did DWTX improve its financial position in Q1 2025?

DWTX raised $4.8M through a common stock offering and had a $19.5M loan converted to equity by CK Life Sciences, strengthening its balance sheet and regaining Nasdaq compliance.

What is Dogwood Therapeutics' current drug pipeline?

The pipeline includes Halneuron速 (Phase 2b for CINP), IMC-2 (Phase 2a for Long-COVID), and IMC-1 (ready for Phase 3 for Fibromyalgia with FDA fast track designation).

When does DWTX expect to report interim data for the Halneuron速 CINP study?

DWTX expects to report interim data from the Phase 2b CINP study in Q4 2025.
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