Dogwood Therapeutics Announces Third Quarter 2024 Financial Results
Dogwood Therapeutics (DWTX) announced Q3 2024 financial results following its formation in October through the combination of Virios Therapeutics and Pharmagesic Holdings. The company secured $19.5M in debt financing, with $16.5M funded and $3.0M expected in Q1 2025. Their pipeline includes Halneuron® for chemotherapy-induced neuropathic pain (Phase 2b), IMC-1 for fibromyalgia (Phase 3-ready), and IMC-2 for Long-COVID (Phase 2a). Q3 net loss was $2.3M ($2.05 per share) compared to $1.2M ($1.62 per share) in Q3 2023. Top-line results from the Long-COVID study are expected mid-November 2024.
Dogwood Therapeutics (DWTX) ha annunciato i risultati finanziari del terzo trimestre 2024 a seguito della sua formazione in ottobre attraverso la fusione di Virios Therapeutics e Pharmagesic Holdings. L'azienda ha ottenuto un finanziamento di debito di $19,5 milioni, con $16,5 milioni già finanziati e $3,0 milioni previsti per il primo trimestre 2025. Il loro pipeline include Halneuron® per il dolore neuropatico indotto dalla chemioterapia (Fase 2b), IMC-1 per la fibromialgia (pronto per la Fase 3) e IMC-2 per Long-COVID (Fase 2a). La perdita netta del terzo trimestre è stata di $2,3 milioni ($2,05 per azione) rispetto a $1,2 milioni ($1,62 per azione) nel terzo trimestre del 2023. I risultati principali dello studio su Long-COVID sono attesi per metà novembre 2024.
Dogwood Therapeutics (DWTX) anunció los resultados financieros del tercer trimestre de 2024 tras su formación en octubre mediante la combinación de Virios Therapeutics y Pharmagesic Holdings. La compañía aseguró financiamiento de deuda por $19.5 millones, de los cuales $16.5 millones ya están financiados y se esperan $3.0 millones para el primer trimestre de 2025. Su cartera incluye Halneuron® para el dolor neuropático inducido por quimioterapia (Fase 2b), IMC-1 para la fibromialgia (listo para Fase 3) e IMC-2 para Long-COVID (Fase 2a). La pérdida neta del tercer trimestre fue de $2.3 millones ($2.05 por acción) en comparación con $1.2 millones ($1.62 por acción) en el tercer trimestre de 2023. Se esperan los resultados principales del estudio sobre Long-COVID a mediados de noviembre de 2024.
Dogwood Therapeutics (DWTX)는 Virios Therapeutics와 Pharmagesic Holdings의 통합을 통해 10월에 설립된 이후 2024년 3분기 재무 결과를 발표했습니다. 회사는 1950만 달러의 부채 자금을 확보했으며, 그 중 1650만 달러가 이미 조달되었고, 300만 달러는 2025년 1분기에 예상됩니다. 그들의 파이프라인에는 화학요법 유발 신경병증 통증을 위한 Halneuron® (2b상), 섬유근육통을 위한 IMC-1 (3상 준비), 그리고 장기 COVID를 위한 IMC-2 (2a상)가 포함되어 있습니다. 3분기 순손실은 230만 달러($2.05 주당)로, 2023년 3분기 $120만 달러($1.62 주당)와 비교됩니다. Long-COVID 연구의 주요 결과는 2024년 11월 중반에 발표될 예정입니다.
Dogwood Therapeutics (DWTX) a annoncé les résultats financiers du troisième trimestre 2024 suite à sa formation en octobre par la fusion de Virios Therapeutics et de Pharmagesic Holdings. L'entreprise a obtenu un financement par emprunt de 19,5 millions de dollars, dont 16,5 millions de dollars ont été financés et 3,0 millions de dollars sont attendus pour le premier trimestre 2025. Leur pipeline comprend Halneuron® pour la douleur neuropathique induite par la chimiothérapie (Phase 2b), IMC-1 pour la fibromyalgie (prêt pour la Phase 3) et IMC-2 pour Long-COVID (Phase 2a). La perte nette au troisième trimestre était de 2,3 millions de dollars (2,05 dollars par action) contre 1,2 million de dollars (1,62 dollar par action) au troisième trimestre 2023. Les résultats principaux de l'étude sur Long-COVID sont attendus pour la mi-novembre 2024.
Dogwood Therapeutics (DWTX) hat die finanziellen Ergebnisse für das dritte Quartal 2024 bekannt gegeben, nachdem das Unternehmen im Oktober durch die Fusion von Virios Therapeutics und Pharmagesic Holdings gegründet wurde. Das Unternehmen sicherte sich eine Fremdfinanzierung in Höhe von 19,5 Millionen US-Dollar, von denen 16,5 Millionen US-Dollar bereits finanziert wurden und 3,0 Millionen US-Dollar im ersten Quartal 2025 erwartet werden. Ihr Portfolio umfasst Halneuron® zur Behandlung von durch Chemotherapie induzierten neuropathischen Schmerzen (Phase 2b), IMC-1 zur Behandlung von Fibromyalgie (bereit für Phase 3) und IMC-2 für Long-COVID (Phase 2a). Der Nettoverlust im dritten Quartal betrug 2,3 Millionen US-Dollar (2,05 US-Dollar je Aktie) im Vergleich zu 1,2 Millionen US-Dollar (1,62 US-Dollar je Aktie) im dritten Quartal 2023. Die Ergebnisse der Long-COVID-Studie werden für Mitte November 2024 erwartet.
- Secured $19.5M in committed debt financing
- FDA Fast Track designation for Halneuron® and IMC-1
- Multiple late-stage assets in pipeline targeting large markets
- Increased net loss to $2.3M in Q3 2024 from $1.2M in Q3 2023
- Current cash position insufficient for 12-month operations
- Additional $3.0M funding needed to continue operations through 2025
Insights
The formation of Dogwood Therapeutics through the combination with Pharmagesic represents a significant strategic shift, bringing
The pipeline expansion with Halneuron® adds significant potential value, particularly given its FDA fast track designation for CINP. However, the
The diversified late-stage pipeline targeting multiple high-value markets shows promise. Halneuron®'s non-opioid approach to chemotherapy-induced neuropathic pain addresses a critical unmet need, while IMC-1 and IMC-2 target substantial markets in fibromyalgia and Long-COVID respectively. The imminent mid-November 2024 readout for the Long-COVID Phase 2a study represents a important near-term catalyst, while the Halneuron® Phase 2b interim data in 2H 2025 could validate the platform's potential in pain management.
- Dogwood Therapeutics, Inc. (Nasdaq: “DWTX”) formed in October by combination of Virios Therapeutics, Inc. and Pharmagesic (Holdings) Inc.,
- Expanded pipeline with multiple programs in large markets with high unmet need -
- Strategic financing results in combined working capital of approximately
- Top-line results from Long-COVID Phase 2a study expected in mid-November 2024 -
- NaV 1.7 inhibition pain treatment, Halneuron®, Phase 2b study for chemotherapy-induced neuropathic pain expected interim readout 2H 2025 -
ATLANTA, Nov. 07, 2024 (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 third quarter ended September 30, 2024 and provided a business update.
“The formation of Dogwood Therapeutics last month represents a transformational expansion of our pipeline with the addition of Halneuron®, a non-opioid, novel NaV 1.7 modulator to treat neuropathic pain associated with chemotherapy, purposefully complementing our promising development assets IMC-1 and IMC-2,” said Greg Duncan, Chief Executive Officer of Dogwood Therapeutics. “The concurrent strategic financing to be provided by an affiliate of CK Life Sciences Int’l., (Holdings) Inc. (“CKLS”), former owner of Pharmagesic (Holdings) Inc., provides us with operating capital through 2025. We see this as a win-win for legacy Virios shareholders and CKLS, with both short-term and medium-term value creation opportunities associated with forthcoming data from the Bateman-Horne Center (“BHC”) managed IMC-2 Phase 2 Long-COVID trial, and the Halneuron® Phase 2b interim data projected for the second half of next year.”
Key Highlights
- Dogwood’s expanded pipeline includes three late-stage assets: Halneuron®, currently in Phase 2b development for chemotherapy-induced neuropathic pain (“CINP”); IMC-1, poised for Phase 3 development as a treatment for fibromyalgia (“FM”); and IMC-2, currently in Phase 2 development to treat Long-COVID (“LC”) sequelae.
- In connection with the Combination, the Company announced that it raised
$19.5 million in committed debt financing by an affiliate of CKLS in two tranches with$16.5 million funded as of October 7, 2024 and an additional$3.0 million to be funded in 1Q 2025, subject to certain conditions. This financing is expected to fund research and operations through several key milestones, including the release of results from the Halneuron® Phase 2b interim analysis assessment expected in 2H 2025. - Top-line results from the ongoing BHC IMC-2 LC Phase 2a study, assessing two doses of the combination of valacyclovir + celecoxib versus placebo, are expected by mid-November 2024.
Dogwood Therapeutics Proprietary Pipeline Includes:
- Halneuron® is in Phase 2b development as a non-opioid, NaV 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 2H 2025.
- IMC-2 (valacyclovir + celecoxib) is in Phase 2a development as a combination antiviral treatment for LC.
Next milestone: Topline data from an investigator led, double blind controlled proof of concept study, assessing two doses of IMC-2 vs placebo, are expected in mid-November 2024.
- IMC-1 (famciclovir + celecoxib) is ready for Phase 3 development as a combination antiviral treatment for FM. IMC-1 has been granted fast track designation by the FDA for the treatment of FM.
Dogwood is exploring partnerships for IMC-1 to execute the Phase 3 FM program agreed upon by the FDA.
Third Quarter 2024 Financial Results
Research and development expenses increased by
General and administrative expenses increased by
Net loss for the third quarter of 2024 was
The Company estimates that its current cash of
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 1.7 analgesic program is centered on lead development candidate, Halneuron® which is a voltage-gated sodium channel blocker, a mechanism known to be effective for reducing pain. Halneuron® treatment has demonstrated pain reduction of both general cancer related pain and CINP. Interim data from the forthcoming Phase 2 CINP study are expected in 2H 2025. The antiviral program includes IMC-1 and IMC-2, which are novel, proprietary, fixed dose combinations of nucleoside analog, anti-herpes antivirals and the anti-inflammatory agent, celecoxib, for the treatment of illnesses believed to be related to reactivation of previously dormant herpes viruses, including FM and LC. Top-line data from an ongoing IMC-2 Phase 2 LC study are expected in mid-November 2024. IMC-1 is poised to progress into Phase 3 development as a treatment for FM and is the focus of external partnership activities. For more information, please visit www.dwtx.com.
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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.
Contact:
IR@dwtx.com
DOGWOOD THERAPEUTICS
Selected Financial Data
(unaudited)
| Condensed Statements of Operations Data | Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||||||
| 2024 | 2023 | 2024 | 2023 | |||||||||||||
| Revenue | $ | — | $ | — | $ | — | $ | — | ||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | 535,162 | 374,200 | 1,214,964 | 1,429,757 | ||||||||||||
| General and administrative | 1,766,010 | 900,089 | 3,470,133 | 2,879,036 | ||||||||||||
| Total operating expenses | 2,301,172 | 1,274,289 | 4,685,097 | 4,308,793 | ||||||||||||
| Loss from operations | (2,301,172 | ) | (1,274,289 | ) | (4,685,097 | ) | (4,308,793 | ) | ||||||||
| Other Income: | ||||||||||||||||
| Interest income | 20,488 | 39,215 | 63,245 | 115,951 | ||||||||||||
| Total Other income | 20,488 | 39,215 | 63,245 | 115,951 | ||||||||||||
| Net loss | $ | (2,280,684 | ) | $ | (1,235,074 | ) | $ | (4,621,852 | ) | $ | (4,192,842 | ) | ||||
| Net loss per share of common stock — basic and diluted, as adjusted | $ | (2.05 | ) | $ | (1.62 | ) | $ | (4.95 | ) | $ | (5.63 | ) | ||||
| Weighted average shares outstanding — basic and diluted, as adjusted | 1,110,317 | 763,750 | 932,872 | 774,586 | ||||||||||||
| Condensed Balance Sheet Data | September 30, | December 31, | |||||
| 2024 | 2023 | ||||||
| Cash | $ | 2,039,819 | $ | 3,316,946 | |||
| Total assets | 2,283,249 | 4,165,442 | |||||
| Total liabilities | 1,333,818 | 358,548 | |||||
| Total stockholders’ equity | 949,431 | 3,806,894 | |||||
Source: Dogwood Therapeutics, Inc.
FAQ
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