DWTX
Dogwood TherapeuticsFDocument history
Earnings documents stored for DWTX.
Investor releaseQuarter not tagged2026-08-13Dogwood Therapeutics Announces Second Quarter 2026 Financial Results
GlobeNewswire
Dogwood Therapeutics Announces Second Quarter 2026 Financial Results
- Halneuron® Phase 2b trial in Chemotherapy Induced Neuropathy on track for top-line results in fall 2026, 217 patients enrolled – - Commencement of Phase 2b Long-Term Extension Study to assess Halneuron® reduction in pain over three months of treatment – - Appointment of Iain Dukes, D.Phil., Venture Partner at OrbiMed, as Chair of Scientific Advisory Board – - Announced Worldwide Development and Commercialization Partnership for Legacy Antiviral Assets with potential value up to $100M to Dogwood Therapeutics and its CVR Holders – ALPHARETTA, Ga., Aug. 13, 2026 (GLOBE NEWSWIRE) -- Dogwood Therapeutics, Inc. (Nasdaq: DWTX) (“Dogwood” or the “Company”), a company that focuses on developing first-in-class, new non-opioid medicines to treat pain and neuropathy, today announced financial results for the second quarter ended June 30, 2026. “Topline data readout for our Halneuron® Phase 2b trial is on track for this fall, a potentially transformative moment for the care of CINP patients as well as Dogwood,” said Greg Duncan, Chief Executive Officer of Dogwood Therapeutics. “Halneuron® has demonstrated statistically significant and durable pain reduction in the clinical data developed to date, with an acceptable safety profile. Interim results from the on-going Phase 2b trial demonstrated Halneuron® treatment separating from placebo in terms of pain improvement. We anticipate enrolling over 220 patients to provide 80+% statistical power to support a clinically significant pain reduction effect when we report our results this fall,” Mr. Duncan continued. “If successful, we believe Halneuron® could represent the first new therapeutic agent for treating CINP, a condition for which there are currently no approved therapies.” Key Highlights The Company currently has enrolled 217 patients in its Halneuron® Phase 2b Chemotherapy Induced Neuropathic Pain (“CINP”) study, with top-line results readout expected in the fall of 2026. SP16 granted IND approval from the FDA. Study to begin enrolling in the second-half of 2026 for the treatment of chemotherapy induced pain and peripheral neuropathy (“CIPPN”). The study is fully funded by the National Cancer Institute and will be conducted at the University of Virginia. Dogwood commences Phase 2b long-term extension study to assess Halneuron®’s reduction in pain over three months of treatment. Patients completing the ongoing Halneur…Read full documentShow less
- Halneuron® Phase 2b trial in Chemotherapy Induced Neuropathy on track for top-line results in fall 2026, 217 patients enrolled – - Commencement of Phase 2b Long-Term Extension Study to assess Halneuron® reduction in pain over three months of treatment – - Appointment of Iain Dukes, D.Phil., Venture Partner at OrbiMed, as Chair of Scientific Advisory Board – - Announced Worldwide Development and Commercialization Partnership for Legacy Antiviral Assets with potential value up to $100M to Dogwood Therapeutics and its CVR Holders – ALPHARETTA, Ga., Aug. 13, 2026 (GLOBE NEWSWIRE) -- Dogwood Therapeutics, Inc. (Nasdaq: DWTX) (“Dogwood” or the “Company”), a company that focuses on developing first-in-class, new non-opioid medicines to treat pain and neuropathy, today announced financial results for the second quarter ended June 30, 2026. “Topline data readout for our Halneuron® Phase 2b trial is on track for this fall, a potentially transformative moment for the care of CINP patients as well as Dogwood,” said Greg Duncan, Chief Executive Officer of Dogwood Therapeutics. “Halneuron® has demonstrated statistically significant and durable pain reduction in the clinical data developed to date, with an acceptable safety profile. Interim results from the on-going Phase 2b trial demonstrated Halneuron® treatment separating from placebo in terms of pain improvement. We anticipate enrolling over 220 patients to provide 80+% statistical power to support a clinically significant pain reduction effect when we report our results this fall,” Mr. Duncan continued. “If successful, we believe Halneuron® could represent the first new therapeutic agent for treating CINP, a condition for which there are currently no approved therapies.” Key Highlights The Company currently has enrolled 217 patients in its Halneuron® Phase 2b Chemotherapy Induced Neuropathic Pain (“CINP”) study, with top-line results readout expected in the fall of 2026. SP16 granted IND approval from the FDA. Study to begin enrolling in the second-half of 2026 for the treatment of chemotherapy induced pain and peripheral neuropathy (“CIPPN”). The study is fully funded by the National Cancer Institute and will be conducted at the University of Virginia. Dogwood commences Phase 2b long-term extension study to assess Halneuron®’s reduction in pain over three months of treatment. Patients completing the ongoing Halneuron® 4-week CINP Phase 2b study are now eligible to enroll in the new 12-week open-label follow-on trial. The Company appointed Iain Dukes, D.Phil., Venture Partner at OrbiMed, as Chair of its Scientific Advisory Board. Cash on hand of $9.6 million provides operational runway through the Phase 2b readout in the fourth quarter of 2026. Second Quarter 2026 Financial Results Research and development expenses for the second quarter of 2026 were $3.2 million, compared to $2.6 million for the second quarter of 2025. The $0.6 million increase quarter over quarter primarily related to an increase in the Halneuron® Phase 2b CINP study costs of $0.7 million offset by a decrease in drug development and manufacturing costs of $0.1 million. General and administrative expenses for the second quarter of 2026 were $1.6 million, compared to $1.3 million for the second quarter of 2025. The $0.3 million increase quarter over quarter was primarily due to increases in salaries and related personnel costs of $0.3 million and an increase in franchise fees of $0.1 million offset by a decrease in public company costs of $0.1 million. During the first and second quarter of 2026, the Company experienced a decline in its stock price resulting in market capitalization being less than stockholders’ equity, which management concluded was an impairment indicator. As a result, the Company performed a quantitative assessment for goodwill and IPR&D impairment and recognized a net non-cash impairment charge of $6.7 million. This IPR&D impairment, which has no bearing on the Company’s cash runway, is comprised of a $9.2 million non-cash expense in the second quarter of 2026 which was partially offset by a reduction in the Company’s deferred tax liability expense of $2.5 million. Net loss attributable to common stockholders for the second quarter of 2026 was $11.5 million, or $0.34 basic and diluted net loss per share, compared to a net loss attributable to common stockholders of $3.8 million, or $1.99 basic and diluted net loss per share, for the second quarter of 2025. About Dogwood Therapeutics Dogwood Therapeutics (Nasdaq: DWTX) is a development-stage biopharmaceutical company focused on developing first-in-class, non-opioid medicines to treat pain and neuropathic disorders. Dogwood’s research pipeline includes two first-in-class development candidates, Halneuron® and SP16 IV. Our lead product candidate, Halneuron®, is in Phase 2b development to treat pain conditions including the neuropathic pain associated with chemotherapy treatment. Halneuron® has been granted fast track designation from the FDA for the treatment of CINP. Halneuron® is a non-opioid, NaV 1.7 analgesic 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 CINP. SP16 IV is a low-density lipoprotein receptor related protein-1 agonist (“LRP1”) with potential to treat neuropathy and prevent or repair nerve damage following chemotherapy. SP16 acts as an LRP1 agonist that in turn provides alpha-1-antitrypsin-like activity. Consistent with alpha-1-antitrypsin anti-inflammatory and immunomodulatory actions, SP16 preclinically demonstrated anti-inflammatory (analgesic) action via potential reductions in IL-6, IL-8, IL1B and TNF-alpha levels, as well as potential to repair damaged tissue via increases in pAKT and pERK that regulate fundamental processes like growth, proliferation and survival. The forthcoming SP16 IV Phase 1b CIPPN trial is fully funded by the National Cancer Institute. Dogwood Therapeutics’ largest shareholder is a member of CK Life Sciences Int’l., (Holdings) Inc., which is listed on the Hong Kong Stock Exchange (Stock code: 0775). For more information, please visit www.dwtx.com. Development and Commercialization Partnership Payments To the extent that any payment to Dogwood resulting from the development and commercialization partnership constitutes either an “Upfront Payment” or a “Milestone Payment” under the terms and conditions applicable to the contingent value rights (“CVRs”) issued by Dogwood on October 17, 2024, Dogwood will cause any required amounts to be delivered to the rights agent for further payment to holders of the CVRs. 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 most recently filed Annual Report on Form 10-K, 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: Dan FerryManaging DirectorLifeSci Advisors, [email protected] -Financial Tables Follow- DOGWOOD THERAPEUTICSSelected Financial Data (unaudited) Source: Dogwood Therapeutics, Inc.
Investor releaseQuarter not tagged2026-05-14Dogwood Therapeutics Announces First Quarter 2026 Financial Results
GlobeNewswire
Dogwood Therapeutics Announces First Quarter 2026 Financial Results
- Halneuron® Phase 2b trial in Chemotherapy Induced Neuropathy on track for top-line results in fall 2026 - - FDA acceptance of SP16 Investigational New Drug Application for the treatment of Chemotherapy Induced Pain and Neuropathy – - Announces Worldwide Development and Commercialization Partnership for Legacy Antiviral Assets with potential value up to $100M to Dogwood and its current and former shareholders - ALPHARETTA, Ga., May 14, 2026 (GLOBE NEWSWIRE) -- Dogwood Therapeutics, Inc. (Nasdaq: DWTX) (“Dogwood” or the “Company”), a company that focuses on developing first-in-class, new non-opioid medicines to treat pain and neuropathy, today announced financial results for the first quarter ended March 31, 2026. “Dogwood is off to a strong operational start to 2026 driven by significant pipeline progress for both Halneuron®, with Phase 2b data anticipated this fall, and SP16, which received FDA clearance to progress into Phase 1b development this quarter,” said Greg Duncan, Chief Executive Officer of Dogwood Therapeutics. “Furthermore, we executed a global development license for our legacy combination antiviral assets.” Key Highlights The Company currently has enrolled 164 patients in its Halneuron® Phase 2b Chemotherapy Induced Neuropathic Pain (“CINP”) study, with top-line results expected fall of 2026. SP16 granted IND approval from the FDA. Study to begin enrolling in mid-2026 for the treatment of chemotherapy-induced pain and peripheral neuropathy (“CIPPN”). It is fully funded by the National Cancer Institute and will be conducted at the University of Virginia. In January 2026, the Company completed a financing of up to $26.9 million to progress Halneuron® through Phase 2b development, of which gross proceeds of $12.5 million have been received. Cash on hand of $13.2 million provides operational runway into the fourth quarter of 2026. Dogwood Therapeutics Proprietary Pipeline Includes: Halneuron® is in Phase 2b clinical 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. Top line results from the ongoing Phase 2b trial are expected in the fall of 2026. SP16 IV is a low-density lipoprotein receptor related protein-1 agonist (LRP1) with pote…Read full documentShow less
- Halneuron® Phase 2b trial in Chemotherapy Induced Neuropathy on track for top-line results in fall 2026 - - FDA acceptance of SP16 Investigational New Drug Application for the treatment of Chemotherapy Induced Pain and Neuropathy – - Announces Worldwide Development and Commercialization Partnership for Legacy Antiviral Assets with potential value up to $100M to Dogwood and its current and former shareholders - ALPHARETTA, Ga., May 14, 2026 (GLOBE NEWSWIRE) -- Dogwood Therapeutics, Inc. (Nasdaq: DWTX) (“Dogwood” or the “Company”), a company that focuses on developing first-in-class, new non-opioid medicines to treat pain and neuropathy, today announced financial results for the first quarter ended March 31, 2026. “Dogwood is off to a strong operational start to 2026 driven by significant pipeline progress for both Halneuron®, with Phase 2b data anticipated this fall, and SP16, which received FDA clearance to progress into Phase 1b development this quarter,” said Greg Duncan, Chief Executive Officer of Dogwood Therapeutics. “Furthermore, we executed a global development license for our legacy combination antiviral assets.” Key Highlights The Company currently has enrolled 164 patients in its Halneuron® Phase 2b Chemotherapy Induced Neuropathic Pain (“CINP”) study, with top-line results expected fall of 2026. SP16 granted IND approval from the FDA. Study to begin enrolling in mid-2026 for the treatment of chemotherapy-induced pain and peripheral neuropathy (“CIPPN”). It is fully funded by the National Cancer Institute and will be conducted at the University of Virginia. In January 2026, the Company completed a financing of up to $26.9 million to progress Halneuron® through Phase 2b development, of which gross proceeds of $12.5 million have been received. Cash on hand of $13.2 million provides operational runway into the fourth quarter of 2026. Dogwood Therapeutics Proprietary Pipeline Includes: Halneuron® is in Phase 2b clinical 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. Top line results from the ongoing Phase 2b trial are expected in the fall of 2026. SP16 IV is a low-density lipoprotein receptor related protein-1 agonist (LRP1) with potential to treat neuropathy and prevent or repair nerve damage following chemotherapy. SP16 acts as an LRP1 agonist that in turn provides alpha-1-antitrypsin-like activity. Consistent with alpha-1-antitrypsin anti-inflammatory and immunomodulatory actions, SP16 preclinically demonstrated anti-inflammatory (analgesic) action via potential reductions in IL-6, IL-8, IL1B and TNF-alpha levels, as well as potential to repair damaged tissue via increases in pAKT and pERK that regulate fundamental processes like growth, proliferation and survival. The forthcoming Phase 1b CIPPN trial is fully funded by the National Cancer Institute. First Quarter 2026 Financial Results Research and development expenses for the first quarter of 2026 were $2.7 million, compared to $2.4 million for the first quarter of 2025. The $0.3 million increase quarter over quarter was primarily related to an increase in drug development costs for Halneuron® of $0.1 million and salaries and related personnel costs of $0.2 million. General and administrative expenses for the first quarter of 2026 were $2.4 million, compared to $2.0 million for the first quarter of 2025. The $0.4 million increase quarter over quarter was primarily due to an increase in salaries and related personnel costs of $0.5 million offset by a decrease in franchise fees of $0.1 million. Net loss attributable to common stockholders for the first quarter of 2026 was $5.0 million or $0.15 basic and diluted net loss per share, compared to a net loss attributable to common stockholders of $12.2 million, or $8.45 basic and diluted net loss per share, for the first quarter of 2025. About Dogwood Therapeutics Dogwood Therapeutics (Nasdaq: DWTX) is a development-stage biopharmaceutical company focused on developing first-in-class, non-opioid medicines to treat pain and neuropathic disorders. The Dogwood research pipeline includes two first-in-class development candidates, Halneuron® and SP16 IV. Our lead product candidate, Halneuron®, is in Phase 2b development to treat pain conditions including the neuropathic pain associated with chemotherapy treatment. Halneuron® has been granted fast track designation from the FDA for the treatment of CINP. Halneuron® is a non-opioid, NaV 1.7 analgesic 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 CINP. SP16 IV is a low-density lipoprotein receptor related protein-1 agonist (LRP1) with potential to treat neuropathy and prevent or repair nerve damage following chemotherapy. SP16 acts as an LRP1 agonist that in turn provides alpha-1-antitrypsin-like activity. Consistent with alpha-1-antitrypsin anti-inflammatory and immunomodulatory actions, SP16 preclinically demonstrated anti-inflammatory (analgesic) action via potential reductions in IL-6, IL-8, IL1B and TNF-alpha levels, as well as potential to repair damaged tissue via increases in pAKT and pERK that regulate fundamental processes like growth, proliferation and survival. The forthcoming SP16 IV Phase 1b CIPPN trial is fully funded by the National Cancer Institute. Dogwood Therapeutics’ largest shareholder is a member of CK Life Sciences Int’l., (Holdings) Inc., which is listed on the Hong Kong Stock Exchange (Stock code: 0775). For more information, please visit www.dwtx.com. Development and Commercialization Partnership Payments To the extent that any payment to Dogwood resulting from the development and commercialization partnership constitutes either an “Upfront Payment” or a “Milestone Payment” under the terms and conditions applicable to the contingent value rights (“CVRs”) issued by Dogwood on October 17, 2024, Dogwood will cause any required amounts to be delivered to the rights agent for further payment to holders of the CVRs. 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 most recently filed Annual Report on Form 10-K, 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: Dan Ferry Managing Director LifeSci Advisors, LLC [email protected] - Financial Tables Follow- DOGWOOD THERAPEUTICS, INC. Selected Financial Data (unaudited) Source: Dogwood Therapeutics, Inc.
Investor releaseQuarter not tagged2026-05-07Dogwood Therapeutics to Report First Quarter 2026 Financial Results on Thursday, May 14, 2026
GlobeNewswire
Dogwood Therapeutics to Report First Quarter 2026 Financial Results on Thursday, May 14, 2026
ATLANTA, May 07, 2026 (GLOBE NEWSWIRE) -- Dogwood Therapeutics, Inc. (Nasdaq: DWTX) (“Dogwood” or the “Company”), a company that focuses on developing new medicines to treat pain and neuropathy, today announced that it will report first quarter 2026 financial results on Thursday, May 14, 2026, before the open of the financial markets. About Dogwood Therapeutics Dogwood Therapeutics (Nasdaq: DWTX) is a development-stage biopharmaceutical company focused on developing new medicines to treat pain and neuropathic disorders. The Dogwood research pipeline includes two first-in-class development candidates, Halneuron® and SP16 IV. Our lead product candidate, Halneuron®, is in Phase 2b development to treat pain conditions including the neuropathic pain associated with chemotherapy treatment. Halneuron® has been granted fast track designation from the FDA for the treatment of CINP. Halneuron® is a non-opioid, NaV 1.7 analgesic 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”). SP16 IV is a low-density lipoprotein receptor related protein-1 agonist (LRP1) with potential to treat neuropathy and prevent or repair nerve damage following chemotherapy. SP16 acts as an LRP1 agonist that in turn provides alpha-1-antitrypsin-like activity. Consistent with alpha-1-antitrypsin anti-inflammatory and immunomodulatory actions, SP16 preclinically demonstrated anti-inflammatory (analgesic) action via potential reductions in IL-6, IL-8, IL1B and TNF-alpha levels, as well as potential to repair damaged tissue via increases in pAKT and pERK that regulate fundamental processes like growth, proliferation and survival. The forthcoming SP16 IV Phase 1b chemotherapy-induced pain and peripheral neuropathy trial is fully funded by the National Cancer Institute. Dogwood Therapeutic’s largest shareholder is a member of CK Life Sciences Int’l., (Holdings) Inc., which is listed on the Hong Kong Stock Exchange (Stock code: 0775). 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…Read full documentShow less
ATLANTA, May 07, 2026 (GLOBE NEWSWIRE) -- Dogwood Therapeutics, Inc. (Nasdaq: DWTX) (“Dogwood” or the “Company”), a company that focuses on developing new medicines to treat pain and neuropathy, today announced that it will report first quarter 2026 financial results on Thursday, May 14, 2026, before the open of the financial markets. About Dogwood Therapeutics Dogwood Therapeutics (Nasdaq: DWTX) is a development-stage biopharmaceutical company focused on developing new medicines to treat pain and neuropathic disorders. The Dogwood research pipeline includes two first-in-class development candidates, Halneuron® and SP16 IV. Our lead product candidate, Halneuron®, is in Phase 2b development to treat pain conditions including the neuropathic pain associated with chemotherapy treatment. Halneuron® has been granted fast track designation from the FDA for the treatment of CINP. Halneuron® is a non-opioid, NaV 1.7 analgesic 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”). SP16 IV is a low-density lipoprotein receptor related protein-1 agonist (LRP1) with potential to treat neuropathy and prevent or repair nerve damage following chemotherapy. SP16 acts as an LRP1 agonist that in turn provides alpha-1-antitrypsin-like activity. Consistent with alpha-1-antitrypsin anti-inflammatory and immunomodulatory actions, SP16 preclinically demonstrated anti-inflammatory (analgesic) action via potential reductions in IL-6, IL-8, IL1B and TNF-alpha levels, as well as potential to repair damaged tissue via increases in pAKT and pERK that regulate fundamental processes like growth, proliferation and survival. The forthcoming SP16 IV Phase 1b chemotherapy-induced pain and peripheral neuropathy trial is fully funded by the National Cancer Institute. Dogwood Therapeutic’s largest shareholder is a member of CK Life Sciences Int’l., (Holdings) Inc., which is listed on the Hong Kong Stock Exchange (Stock code: 0775). 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 most recently filed Annual Report on Form 10-K, 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. Contact: Dan Ferry Managing Director LifeSci Advisors, LLC [email protected]
Investor releaseQuarter not tagged2026-03-23DWTX: 143 Patients Enrolled in Phase 2b Trial of Halneuron®; Results Expected in 3Q26
Zacks Small Cap Research
DWTX: 143 Patients Enrolled in Phase 2b Trial of Halneuron®; Results Expected in 3Q26
By David Bautz, PhD NASDAQ: DWTX READ THE FULL DWTX RESEARCH REPORT Business Update 143 Patients Enrolled in Phase 2b Trial of Halneuron® in CINP; Topline Results in 3Q26 Dogwood Therapeutics, Inc. (NASDAQ: DWTX) is currently conducting the Phase 2b HALT-CINP (Halneuron® Treatment of Chemotherapy-Induced Neuropathic Pain) trial. The Phase 2b trial is a four-week study that is examining the safety and efficacy of Halneuron in patients with moderate-to-severe CINP. The primary efficacy endpoint is the change from baseline at Week 4 in the weekly average of daily 24-hour recall pain intensity scores, which will be recorded in e-diaries on participants’ smartphones. Secondary efficacy endpoints include Patient Global Impression of Change (PIGC), PROMIS Fatigue, PROMIS Sleep, PROMIS-29, Pain Interference, Hospital Anxiety and Depression Scale (HADS), and Neuropathic Pain Symptom Inventory (NPSI). In December 2025, Dogwood announced positive interim results for the trial. Unblinded data were reviewed by the independent statistical review committee, and they concluded that Halneuron-treated patients are demonstrating separation from placebo-treated patients in pain improvement over the four-week study. The interim analysis included data from 97 patients that have completed treatment. The company recently announced that it has completed over 50% of the planned enrollment of the study and that 143 patients have been enrolled. Dogwood is planning to finish enrollment at the end of July 2026 with a projected total patient population of 210 to 240 patients, which would provide 80-85% power to detect a statistically significant Halneuron treatment difference. We anticipate topline results from the trial in the third quarter of 2026. Previously, the company announced that data from the first 116 patients to complete the study showed an overall dropout rate of approximately 4.3%, which is much lower than the dropout rates for both duloxetine (20%+) and pregabalin (30-40%). The patient population had a mean 5-year duration of moderate-to-severe neuropathic pain, and it includes a majority of refractory CINP patients, as judged by the fact that approximately 2/3rd of the population was on concomitant pain medications. Dogwood also recently completed a financing of up to $26.9 million, of which $12.5 million has been received, which will finance operations through the release…Read full documentShow less
By David Bautz, PhD NASDAQ: DWTX READ THE FULL DWTX RESEARCH REPORT Business Update 143 Patients Enrolled in Phase 2b Trial of Halneuron® in CINP; Topline Results in 3Q26 Dogwood Therapeutics, Inc. (NASDAQ: DWTX) is currently conducting the Phase 2b HALT-CINP (Halneuron® Treatment of Chemotherapy-Induced Neuropathic Pain) trial. The Phase 2b trial is a four-week study that is examining the safety and efficacy of Halneuron in patients with moderate-to-severe CINP. The primary efficacy endpoint is the change from baseline at Week 4 in the weekly average of daily 24-hour recall pain intensity scores, which will be recorded in e-diaries on participants’ smartphones. Secondary efficacy endpoints include Patient Global Impression of Change (PIGC), PROMIS Fatigue, PROMIS Sleep, PROMIS-29, Pain Interference, Hospital Anxiety and Depression Scale (HADS), and Neuropathic Pain Symptom Inventory (NPSI). In December 2025, Dogwood announced positive interim results for the trial. Unblinded data were reviewed by the independent statistical review committee, and they concluded that Halneuron-treated patients are demonstrating separation from placebo-treated patients in pain improvement over the four-week study. The interim analysis included data from 97 patients that have completed treatment. The company recently announced that it has completed over 50% of the planned enrollment of the study and that 143 patients have been enrolled. Dogwood is planning to finish enrollment at the end of July 2026 with a projected total patient population of 210 to 240 patients, which would provide 80-85% power to detect a statistically significant Halneuron treatment difference. We anticipate topline results from the trial in the third quarter of 2026. Previously, the company announced that data from the first 116 patients to complete the study showed an overall dropout rate of approximately 4.3%, which is much lower than the dropout rates for both duloxetine (20%+) and pregabalin (30-40%). The patient population had a mean 5-year duration of moderate-to-severe neuropathic pain, and it includes a majority of refractory CINP patients, as judged by the fact that approximately 2/3rd of the population was on concomitant pain medications. Dogwood also recently completed a financing of up to $26.9 million, of which $12.5 million has been received, which will finance operations through the release of topline data. In addition, the recent financing will also allow Dogwood to initiate an open-label extension that will test different dosing regimens and frequencies to help complete the data package that the company intends to present to the FDA following release of the Phase 2b topline data, if positive. The data obtained from these studies will be used to guide the design of a Phase 3 program. In addition, Dogwood now has sufficient capital to conduct a bridging study with synthetic Halneuron, which the company is planning to use in the Phase 3 program. SP16 Trial to Initiate in Mid-2026 In September 2025, Dogwood announced a royalty-free, global license deal with Serpin Pharma for SP16 for the management of cancer related pain (CRP), including a broad range of chemotherapy induced neuropathy symptoms. SP16 is an intravenously administered peptide that functions as an LRP1 agonist and has shown anti-inflammatory and neural repair activity. For a full overview of SP16, please see our previous report here. A Phase 1b trial of SP16 in Chemotherapy Induced Peripheral Neuropathy (CIPN) is scheduled to initiate in mid-2026 and is fully funded by the National Cancer Institute (NCI). It will take place at the University of Virginia. Up to 32 patients with metastatic cancer who are experiencing neuropathy from their concurrent chemotherapy will be enrolled into one of four dosing cohorts, with each cohort having six patients on SP16 and two on placebo. Endpoints for the study include safety, pharmacokinetics of SP16, the prevention of CIPN, and adherence to chemotherapy. Positive results from the trial may lead to a Phase 2a trial that could be eligible for funding from NCI. Financial Update On March 18, 2026, Dogwood announced financial results for 2025. As expected, the company did not report any revenues in 2025. R&D expenses for the full year ending December 31, 2025, were $21.8 million compared to $3.5 million for the full year ending December 31, 2024. The increase was primarily due to acquired in-process research and development expenses of $12.0 million associated with the licensing agreement of SP16 and the impact of the business combination with Pharmagesic Inc, along with increased clinical trial, drug development, and manufacturing expenses. G&A expenses for 2025 were $6.1 million compared to $8.7 million for 2024. The decrease was primarily due to a decrease in nonrecurring transaction costs of $3.9 million related to the combination of Pharmagesic in October 2024 and decreased costs associated with being a public company, partially offset by increases in salaries, legal and professional fees, franchise tax fees, and other general and administrative costs. As of December 31, 2025, Dogwood had approximately $6.5 million in cash and cash equivalents. As mentioned above, subsequent to the end of the year, the company executed a financing for up to $26.8 million, with gross proceeds of $12.5 million already received and the potential for up to an additional $14.4 million in gross proceeds from the exercise of warrants. We estimate this is sufficient to fund operations past the announcement of topline results for the Phase 2b trial of Halneuron. As of March 10, 2026, Dogwood had approximately 33.4 million common shares outstanding and, when factoring in stock options and warrants, a fully diluted share count of approximately 38.9 million. Conclusion Now that Dogwood has secured sufficient financing to fund operations past the anticipated data release from the Phase 2b HALT-CINP trial, the company can turn its attention to finishing enrollment ahead of the anticipated data readout in the third quarter of 2026. The financing will also allow the company to collect additional data on dosing regimens through an open-label extension that will help guide the design of the Phase 3 program. We look forward to additional enrollment updates from the company as the year progresses and topline results in the third quarter of 2026. With no changes to our model, our valuation remains at $15 per share. SUBSCRIBE TO ZACKS SMALL CAP RESEARCH to receive our articles and reports emailed directly to you each morning. Please visit our website for additional information on Zacks SCR. DISCLOSURE: Zacks SCR has received compensation from the issuer directly, from an investment manager, or from an investor relations consulting firm, engaged by the issuer, for providing research coverage for a period of no less than one year. Research articles, as seen here, are part of the service Zacks SCR provides and Zacks SCR receives payments totaling a maximum fee of up to $50,000 annually for these services provided to or regarding the issuer. Full Disclaimer HERE.
Investor releaseQuarter not tagged2026-03-18Dogwood Therapeutics Reports Fourth Quarter and Full Year 2025 Financial Results
GlobeNewswire
Dogwood Therapeutics Reports Fourth Quarter and Full Year 2025 Financial Results
ATLANTA, March 18, 2026 (GLOBE NEWSWIRE) -- Dogwood Therapeutics, Inc. (Nasdaq: DWTX) (the “Company”), a development-stage biotechnology company developing new medicines to treat pain and neuropathy, today announced financial results for the fourth quarter and full year ended December 31, 2025. “The Company continues to execute at a high level, including recruitment of 143 patients in our ongoing Halneuron® Phase 2b trial, commencement of a Phase 2b extension trial and the recent execution of a financing to provide us with operational runway through the Phase 2b final data readout later this year,” said Greg Duncan, Chief Executive Officer of Dogwood Therapeutics. Key Highlights In December 2025, the Company announced the results of an interim analysis of the Halneuron® Phase 2b trial. The independent statistical review committee concluded that Halneuron® was separating from placebo in the 97 patient subset included in the analysis. The independent statistical review committee determined that a sample size of 210-240 is expected to provide 80-85% power to see a statistically significant Halneuron® pain reduction result versus placebo. CINP Phase 2b study is over 50% enrolled, Company expects top-line results in Q3 2026. In January 2026, the Company completed a financing of up to $26.9 million to progress Halneuron® through Phase 2b development, of which gross proceeds of $12.5 million have been received. Fourth Quarter 2025 Financial Results Research and development expenses for the fourth quarter of 2025 remained level with the fourth quarter of 2024 at $2.3 million. General and administrative expenses for the fourth quarter of 2025 were $1.5 million, compared to $5.2 million for the fourth quarter of 2024. The $3.7 million decrease quarter over quarter was primarily due to a decrease in nonrecurring transaction costs of $3.9 million related to the combination with Pharmagesic (Holdings) Inc. in October 2024 and a decrease in salaries and related personnel costs of $0.2 million offset by an increase in legal and professional fees of $0.3 million and expenses associated with being a public company of $0.1 million. Net loss attributable to common stockholders for the fourth quarter of 2025 was $3.8 million, or $0.26 basic and diluted net loss per share, compared to a net loss attributable to common stockholders of $8.2 million, or $6.29 basic and diluted net…Read full documentShow less
ATLANTA, March 18, 2026 (GLOBE NEWSWIRE) -- Dogwood Therapeutics, Inc. (Nasdaq: DWTX) (the “Company”), a development-stage biotechnology company developing new medicines to treat pain and neuropathy, today announced financial results for the fourth quarter and full year ended December 31, 2025. “The Company continues to execute at a high level, including recruitment of 143 patients in our ongoing Halneuron® Phase 2b trial, commencement of a Phase 2b extension trial and the recent execution of a financing to provide us with operational runway through the Phase 2b final data readout later this year,” said Greg Duncan, Chief Executive Officer of Dogwood Therapeutics. Key Highlights In December 2025, the Company announced the results of an interim analysis of the Halneuron® Phase 2b trial. The independent statistical review committee concluded that Halneuron® was separating from placebo in the 97 patient subset included in the analysis. The independent statistical review committee determined that a sample size of 210-240 is expected to provide 80-85% power to see a statistically significant Halneuron® pain reduction result versus placebo. CINP Phase 2b study is over 50% enrolled, Company expects top-line results in Q3 2026. In January 2026, the Company completed a financing of up to $26.9 million to progress Halneuron® through Phase 2b development, of which gross proceeds of $12.5 million have been received. Fourth Quarter 2025 Financial Results Research and development expenses for the fourth quarter of 2025 remained level with the fourth quarter of 2024 at $2.3 million. General and administrative expenses for the fourth quarter of 2025 were $1.5 million, compared to $5.2 million for the fourth quarter of 2024. The $3.7 million decrease quarter over quarter was primarily due to a decrease in nonrecurring transaction costs of $3.9 million related to the combination with Pharmagesic (Holdings) Inc. in October 2024 and a decrease in salaries and related personnel costs of $0.2 million offset by an increase in legal and professional fees of $0.3 million and expenses associated with being a public company of $0.1 million. Net loss attributable to common stockholders for the fourth quarter of 2025 was $3.8 million, or $0.26 basic and diluted net loss per share, compared to a net loss attributable to common stockholders of $8.2 million, or $6.29 basic and diluted net loss per share, for the fourth quarter of 2024. Full Year 2025 Financial Results Research and development expenses for the year ended December 31, 2025 were $21.8 million, compared to $3.5 million for the year ended December 31, 2024. The $18.3 million increase year over year was primarily related to acquired in-process research and development expenses of $12.0 million associated with the licensing agreement of SP16 and the impact of the business combination with Pharmagesic (Holdings) Inc., including increases in expenses for clinical trials of $6.1 million related to the Halneuron® CINP Phase 2b study, drug development and manufacturing costs of $0.3 million and salaries and related personnel costs of $0.3 million, offset by a decrease in research and preclinical costs of $0.4 million. General and administrative expenses for the year ended December 31, 2025 were $6.1 million, compared to $8.7 million for the year ended December 31, 2024. The $2.6 million decrease year over year was primarily due to a decrease in nonrecurring transaction costs of $3.9 million related to the combination of Pharmagesic in October 2024 and a decrease in expenses associated with being a public company of $0.2 million offset by increases in salaries and related personnel costs of $0.5 million, legal and professional fees of $0.6 million, franchise tax fees of $0.2 million and other general and administrative costs of $0.2 million. Net loss attributable to common stockholders for the year ended December 31, 2025 was $35.5 million, or $7.13 basic and diluted net loss per share, compared to a net loss attributable to common stockholders of $12.9 million, or $12.52 basic and diluted net loss per share, for the year ended December 31, 2024. As of December 31, 2025, Dogwood Therapeutics’ cash and cash equivalents totaled $6.5 million. The Company believes that the cash and cash equivalents on hand at December 31, 2025 together with the net proceeds received in January 2026 of $11.4 million after deducting placement agent fees and offering expenses payable by the Company, is expected to fund operations through the Halneuron® Phase 2b final data readout and into the fourth 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 neuropathic disorders. The Dogwood research pipeline includes two first-in-class development candidates, Halneuron® and SP16 IV. Our lead product candidate, Halneuron®, is in Phase 2b development 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. Halneuron® is a non-opioid, NaV 1.7 analgesic 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”). SP16 IV is a low-density lipoprotein receptor related protein-1 (LRP1) agonist with potential to treat neuropathy and prevent or repair nerve damage following chemotherapy. SP16 acts as an LRP1 agonist that in turn provides alpha-1-antitrypsin-like activity. Consistent with alpha-1-antitrypsin anti-inflammatory and immunomodulatory actions, SP16 preclinically demonstrated anti-inflammatory (analgesic) action via potential reductions in IL-6, IL-8, IL1B and TNF-alpha levels, as well as potential to repair damaged tissue via increases in pAKT and pERK that regulate fundamental processes like growth, proliferation and survival. The forthcoming SP16 IV Phase 1b CINP trial will commence following consultation with FDA and is fully funded by the National Cancer Institute. Dogwood Therapeutic’s largest shareholder is a member of CK Life Sciences Int’l., (Holdings) Inc., which is listed on the Hong Kong Stock Exchange (Stock code: 0775). 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 most recently filed Annual Report on Form 10-K, 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: [email protected] -Financial Tables Follow- DOGWOOD THERAPEUTICS Selected Financial Data (unaudited) Source: Dogwood Therapeutics, Inc.
Investor releaseQuarter not tagged2026-02-02Dogwood Therapeutics Announces 50% Enrollment in Ongoing Halneuron® Phase 2b Trial, Top Line Results Anticipated in Q3 2026
GlobeNewswire
Dogwood Therapeutics Announces 50% Enrollment in Ongoing Halneuron® Phase 2b Trial, Top Line Results Anticipated in Q3 2026
- Low early termination rate (4.3%) among the first 116 patients completing the study suggests Halneuron® treatment to be well tolerated - ATLANTA, Feb. 02, 2026 (GLOBE NEWSWIRE) -- Dogwood Therapeutics, Inc. (Nasdaq: DWTX) (the “Company”), a development-stage biotechnology company developing new medicines to treat pain and neuropathy, today announced it has achieved over 50% of the planned enrollment in its ongoing HAL-CINP-203 Phase 2b chemotherapy induced neuropathic pain (“HALT-CINP”) trial. HALT-CINP remains on track for top line results to be available during the third quarter of 2026. “If the HALT-CINP study is successful, Halenuron® would represent a new therapeutic agent for treating chemotherapy-induced neuropathic pain, a condition for which there are currently no approved therapies. There remains a great need for treatment options for the millions of patients suffering from chemotherapy-induced neuropathic pain and we continue to be encouraged by the rate of enrollment, interim outcomes and safety profile,” said Dogwood Therapeutics Chief Medical Officer R. Michael Gendreau, M.D., Ph.D., “Against a history of failed clinical trials, the ongoing Halneuron® clinical trial has the potential to be the first statistically significant trial treating chemotherapy-induced neuropathic pain patients under FDA chronic pain study guidance.” In December 2025, Dogwood announced encouraging results from an interim analysis of 97 patients who had completed treatment in the HALT-CINP study. An independent statistical review committee reviewed unblinded patient treatment data from the Phase 2b trial and concluded that Halneuron® treated patients are demonstrating separation from placebo treated patients in terms of pain improvement over the four-week study. This preliminary evidence of a Halneuron® treatment effect is noteworthy as patients in the interim analysis population presented with an average duration of chemotherapy-induced neuropathic pain of 5 years. The overall study dropout rate of approximately 4.0% is far below rates typically observed in studies of other FDA approved chronic pain medicines. The study is designed to provide statistical power of approximately >80% to detect a Halneuron® treatment difference versus placebo upon study unblinding in the third quarter of 2026. Halneuron® CINP Phase 2b Trial Overview (NCT06848348) HALT-CINP is a randomize…Read full documentShow less
- Low early termination rate (4.3%) among the first 116 patients completing the study suggests Halneuron® treatment to be well tolerated - ATLANTA, Feb. 02, 2026 (GLOBE NEWSWIRE) -- Dogwood Therapeutics, Inc. (Nasdaq: DWTX) (the “Company”), a development-stage biotechnology company developing new medicines to treat pain and neuropathy, today announced it has achieved over 50% of the planned enrollment in its ongoing HAL-CINP-203 Phase 2b chemotherapy induced neuropathic pain (“HALT-CINP”) trial. HALT-CINP remains on track for top line results to be available during the third quarter of 2026. “If the HALT-CINP study is successful, Halenuron® would represent a new therapeutic agent for treating chemotherapy-induced neuropathic pain, a condition for which there are currently no approved therapies. There remains a great need for treatment options for the millions of patients suffering from chemotherapy-induced neuropathic pain and we continue to be encouraged by the rate of enrollment, interim outcomes and safety profile,” said Dogwood Therapeutics Chief Medical Officer R. Michael Gendreau, M.D., Ph.D., “Against a history of failed clinical trials, the ongoing Halneuron® clinical trial has the potential to be the first statistically significant trial treating chemotherapy-induced neuropathic pain patients under FDA chronic pain study guidance.” In December 2025, Dogwood announced encouraging results from an interim analysis of 97 patients who had completed treatment in the HALT-CINP study. An independent statistical review committee reviewed unblinded patient treatment data from the Phase 2b trial and concluded that Halneuron® treated patients are demonstrating separation from placebo treated patients in terms of pain improvement over the four-week study. This preliminary evidence of a Halneuron® treatment effect is noteworthy as patients in the interim analysis population presented with an average duration of chemotherapy-induced neuropathic pain of 5 years. The overall study dropout rate of approximately 4.0% is far below rates typically observed in studies of other FDA approved chronic pain medicines. The study is designed to provide statistical power of approximately >80% to detect a Halneuron® treatment difference versus placebo upon study unblinding in the third quarter of 2026. Halneuron® CINP Phase 2b Trial Overview (NCT06848348) HALT-CINP is a randomized, phase 2b clinical trial evaluating the safety and effectiveness of Halneuron® vs placebo in cancer patients with established neuropathy due to a previous platinum or taxane-based chemotherapy regimen. Participants receive 8 sub-cutaneous doses of Halneuron® or placebo over a 14-day period and are followed for a total of 28 days for safety and effectiveness. The primary endpoint for this study is the change in the weekly average of daily 24-hour recall pain intensity scores from baseline to week four. The study is being conducted at approximately 30 sites in the U.S. Secondary measures will assess Halneuron’s® treatment effects on sleep, fatigue, neuropathy symptoms and overall patient health. Final HALT-CINP Phase 2b trial results are projected for the third 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 neuropathic disorders. The Dogwood research pipeline includes two first-in-class development candidates, Halneuron® and SP16 IV. Our lead product candidate, Halneuron®, is in Phase 2b development to treat pain conditions including the neuropathic pain associated with chemotherapy treatment. Halneuron® has been granted fast track designation from the FDA for the treatment of chemotherapy induced neuropathic pain (“CINP”). Halneuron® is a non-opioid, NaV 1.7 analgesic 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 CINP. SP16 IV is a low-density lipoprotein receptor related protein-1 agonist (“LRP1”) with potential to treat neuropathy and prevent or repair nerve damage following chemotherapy. SP16 acts as an LRP1 agonist that in turn provides alpha-1-antitrypsin-like activity. Consistent with alpha-1-antitrypsin anti-inflammatory and immunomodulatory actions, SP16 preclinically demonstrated anti-inflammatory (analgesic) action via potential reductions in IL-6, IL-8, IL1B and TNF-alpha levels, as well as potential to repair damaged tissue via increases in pAKT and pERK that regulate fundamental processes like growth, proliferation and survival. The forthcoming SP16 IV Phase 1b chemotherapy induced peripheral neuropathy trial is fully funded by the National Cancer Institute. Dogwood Therapeutic’s largest shareholder is a member of CK Life Sciences Int’l., (Holdings) Inc., which is listed on the Hong Kong Stock Exchange (Stock code: 0775). 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 [email protected]
Investor releaseQuarter not tagged2025-12-30DWTX: Positive Interim Results for Halneuron® Phase 2b Trial in CINP; Raising Valuation to $15
Zacks Small Cap Research
DWTX: Positive Interim Results for Halneuron® Phase 2b Trial in CINP; Raising Valuation to $15
By David Bautz, PhD NASDAQ:DWTX READ THE FULL DWTX RESEARCH REPORT Business Update Positive Interim Results for Phase 2b Trial of Halneuron® in CINP On December 22, 2025, Dogwood Therapeutics, Inc. (DWTX) announced positive interim results for the Phase 2b HALT-CINP (Halneuron® Treatment of Chemotherapy-Induced Neuropathic Pain) trial. Unblinded data from the trial was reviewed by the independent statistical review committee and concluded that Halneuron-treated patients are demonstrating separation from placebo-treated patients in pain improvement over the four-week study. The interim analysis included data from 97 patients that have completed treatment. Based on the current pace of enrollment and the interim assessment results, we anticipate topline results from the trial in the third quarter of 2026. The trial is currently 80-85% powered to detect a Halneuron treatment difference based on current patient enrollment trends. The Phase 2b trial is a four-week study that is examining the safety and efficacy of Halneuron in patients with moderate-to-severe CINP. The primary efficacy endpoint is the change from baseline at Week 4 in the weekly average of daily 24-hour recall pain intensity scores, which will be recorded in e-diary’s on participants smartphones. Secondary efficacy endpoints include Patient Global Impression of Change (PIGC), PROMIS Fatigue, PROMIS Sleep, PROMIS-29, Pain Interference, Hospital Anxiety and Depression Scale (HADS), and Neuropathic Pain Symptom Inventory (NPSI). Background on Halneuron Halneuron (tetrodotoxin, TTX), a sodium channel blocker, was originally discovered in the pufferfish and subsequent research has identified the toxin in 13 phyla (in both Eukarya and Bacteria) that includes both marine and terrestrial eukaryotes (Lago et al., 2015). As a natural poison, TTX is extremely effective and is the most potent non-peptide neurotoxin known. It blocks the influx of sodium through voltage-gated sodium channels (NaVs), thereby preventing the initiation and propagation of action potentials in almost all neurons and muscle cells (Stevens et al., 2011). Mammals possess nine voltage-gated sodium channels, NaV1.1-NaV1.9. TTX binds to NaV1.1, NaV1.2, NaV1.3, NaV1.4, NaV1.6, and NaV1.7 (Nieto et al., 2012). NaV1.7 is expressed in all types of dorsal root ganglion (DRG) neurons, sympathetic neurons, Schwann cells, and neuroendocrine cells…Read full documentShow less
By David Bautz, PhD NASDAQ:DWTX READ THE FULL DWTX RESEARCH REPORT Business Update Positive Interim Results for Phase 2b Trial of Halneuron® in CINP On December 22, 2025, Dogwood Therapeutics, Inc. (DWTX) announced positive interim results for the Phase 2b HALT-CINP (Halneuron® Treatment of Chemotherapy-Induced Neuropathic Pain) trial. Unblinded data from the trial was reviewed by the independent statistical review committee and concluded that Halneuron-treated patients are demonstrating separation from placebo-treated patients in pain improvement over the four-week study. The interim analysis included data from 97 patients that have completed treatment. Based on the current pace of enrollment and the interim assessment results, we anticipate topline results from the trial in the third quarter of 2026. The trial is currently 80-85% powered to detect a Halneuron treatment difference based on current patient enrollment trends. The Phase 2b trial is a four-week study that is examining the safety and efficacy of Halneuron in patients with moderate-to-severe CINP. The primary efficacy endpoint is the change from baseline at Week 4 in the weekly average of daily 24-hour recall pain intensity scores, which will be recorded in e-diary’s on participants smartphones. Secondary efficacy endpoints include Patient Global Impression of Change (PIGC), PROMIS Fatigue, PROMIS Sleep, PROMIS-29, Pain Interference, Hospital Anxiety and Depression Scale (HADS), and Neuropathic Pain Symptom Inventory (NPSI). Background on Halneuron Halneuron (tetrodotoxin, TTX), a sodium channel blocker, was originally discovered in the pufferfish and subsequent research has identified the toxin in 13 phyla (in both Eukarya and Bacteria) that includes both marine and terrestrial eukaryotes (Lago et al., 2015). As a natural poison, TTX is extremely effective and is the most potent non-peptide neurotoxin known. It blocks the influx of sodium through voltage-gated sodium channels (NaVs), thereby preventing the initiation and propagation of action potentials in almost all neurons and muscle cells (Stevens et al., 2011). Mammals possess nine voltage-gated sodium channels, NaV1.1-NaV1.9. TTX binds to NaV1.1, NaV1.2, NaV1.3, NaV1.4, NaV1.6, and NaV1.7 (Nieto et al., 2012). NaV1.7 is expressed in all types of dorsal root ganglion (DRG) neurons, sympathetic neurons, Schwann cells, and neuroendocrine cells (Catterall et al., 2005). It is responsible for the perception of pain, which is supported by multiple lines of evidence. Individuals with loss-of-function mutations in the SCN9A gene (which encodes the alpha-subunit of NaV1.7) experience a complete inability to sense pain (Cox et al., 2006) while those with a gain-of-function mutation in SCN9A experience erythromelalgia (Dib-Hajj et al., 2005). In animal models, NaV1.7 nociceptor-specific knockout mice showed increased mechanical and thermal pain thresholds (Nassar et al., 2004). These results led researchers to hypothesize that TTX could be a potential therapeutic to control pain. Halneuron Clinical Trials Previous clinical trials investigating Halneuron include a Phase 2 cancer related pain (CRP) study and a Phase 2 CINP trial. Phase 2 CRP Trial This was a randomized, double blind, parallel design, multicenter trial that enrolled 165 patients with moderate to severe inadequately controlled CRP. All patients were on standard of care pain management. Halneuron or placebo was administered twice a day for four days and all patients recorded their pain response from days 5-8 (early post-injection period) and from days 9-15 (late post-injection period). The results showed a statistically significant improvement in pain outcomes for Halneuron, with 51% of Halneuron patients experiencing a ≥30% reduction in pain compared to only 35% in the placebo group, as shown in the following image. For Global Impression of Pain Change, 55% of Halneuron patients reported an improvement in pain compared to 24% of placebo patients. Conversely, 70% of placebo patients reported no change or worse pain compared to only 37% of patients. In addition to a positive pain response, the duration of pain relief was much higher for Halneuron patients, as shown in the following figure. The average pain response for Halneuron responders was 57.7 days compared to 10.5 days for placebo responders. Lastly, over one-quarter of Halneuron responders (27%) had pain relief that lasted for 30 days or longer after one cycle of treatment. Phase 2 CINP Trial This was a randomized, double blind, dose-finding, placebo controlled, multicenter study in patients with CINP. Various doses of Halneuron were tested over four days of treatment followed by measurement over four weeks. The study included a total of 125 patients across five dosing cohorts (four active and one placebo). The results showed that a dose of 30 mg twice per day for four days demonstrated the highest level of pain reduction compared to placebo, with the responder analysis results given below. Background on CINP CINP is the result of injury to the somatosensory nervous system following chemotherapy treatment (Colvin, 2019). For agents such as paclitaxel and oxaliplatin, the rate of CINP is up to 81% and 98%, respectively (Hershman et al., 2010; Gebremedhn et al., 2018). CINP begins as an acute pain syndrome that coincides with drug administration, however it can progress to a chronic condition following multiple rounds of therapy. The only drug endorsed to treat CINP by the American Society of Clinical Oncology (ASCO) is duloxetine, which showed a significant reduction in pain in a Phase 3 clinical trial (Lavoie Smith et al., 2013). However, the drug is not FDA approved for the treatment of CINP. In addition, in a preclinical oxaliplatin-induced neuropathic pain model, Halneuron was superior to duloxetine based on the paw withdrawal threshold (PWT), a measure of pain tolerance. There are an estimated 1.7 million CINP patients in the seven major markets (U.S., EU5, Japan). Opioids currently account for 30% of the global CINP market, which is estimated to be approximately $1.5 billion. The company also has plans to target CRP, which has a patient population approximately 7.5 times as large as CINP and a market worth approximately $5 billion. Conclusion The positive interim results from the Halneuron Phase 2b trial are very encouraging and we look forward to topline results in the third quarter of 2026. Based on these results we have increased the probability of success for Halneuron in our model, which has increased our valuation to $15 per share. SUBSCRIBE TO ZACKS SMALL CAP RESEARCH to receive our articles and reports emailed directly to you each morning. Please visit our website for additional information on Zacks SCR. DISCLOSURE: Zacks SCR has received compensation from the issuer directly, from an investment manager, or from an investor relations consulting firm, engaged by the issuer, for providing research coverage for a period of no less than one year. Research articles, as seen here, are part of the service Zacks SCR provides and Zacks SCR receives payments totaling a maximum fee of up to $50,000 annually for these services provided to or regarding the issuer. Full Disclaimer HERE.
Investor releaseQuarter not tagged2025-12-22Dogwood Therapeutics Announces Positive Interim Phase 2b Clinical Trial Results in Chemotherapy Induced Neuropathic Pain
GlobeNewswire
Dogwood Therapeutics Announces Positive Interim Phase 2b Clinical Trial Results in Chemotherapy Induced Neuropathic Pain
- Halneuron® treated patients separating from placebo on pain improvement assessment; Company expects top-line results availability in Q3 2026 - - The overall study dropout rate of ~4.4% is far below rates typically observed with other FDA approved chronic pain medicines - ATLANTA, Dec. 22, 2025 (GLOBE NEWSWIRE) -- Dogwood Therapeutics, Inc. (Nasdaq: DWTX) (the “Company”), a development-stage biotechnology company developing new medicines to treat pain and neuropathy, today announces positive results from an interim analysis of 97 patients who had completed treatment in the ongoing Halneuron® Phase 2b chemotherapy induced neuropathic pain (“CINP”) study. The independent statistical review committee reviewed unblinded patient treatment data from the Phase 2b trial and concluded that Halneuron® treated patients are demonstrating separation from placebo treated patients in terms of pain improvement over the four-week study. Based on the current Phase 2b trial enrollment pace and the interim assessment results, the Company continues to expect to have top-line results available during Q3 2026. Current study patient enrollment trends are projected to provide statistical power of approximately 80% to 85% to detect a Halneuron® treatment difference. “We have long believed that Nav 1.7 sodium channel inhibition holds great promise for treating both chronic and acute pain,” said Greg Duncan, Dogwood Therapeutics Chief Executive Officer. “Extrapolation of the current Phase 2b study trends has the potential to represent the first statistically significant trial involving CINP patients under FDA chronic pain study guidance.” This preliminary evidence of a Halneuron® treatment effect is noteworthy as patients in the interim analysis population present an average duration of CINP of 5 years and 67% of patients that met entry criteria were also being treated with stable doses of other chronic pain medicines, including pregabalin, gabapentin, duloxetine, and opioids. In addition, the overall study dropout rate of approximately 4.4% is far below rates typically observed with other FDA approved chronic pain medicines. While still blinded, the Company believes these findings reaffirm the encouraging safety and tolerability profile of Halneuron® observed in previous clinical trials. “There are currently no approved therapies to treat the moderate-to-severe neuropathic pain that…Read full documentShow less
- Halneuron® treated patients separating from placebo on pain improvement assessment; Company expects top-line results availability in Q3 2026 - - The overall study dropout rate of ~4.4% is far below rates typically observed with other FDA approved chronic pain medicines - ATLANTA, Dec. 22, 2025 (GLOBE NEWSWIRE) -- Dogwood Therapeutics, Inc. (Nasdaq: DWTX) (the “Company”), a development-stage biotechnology company developing new medicines to treat pain and neuropathy, today announces positive results from an interim analysis of 97 patients who had completed treatment in the ongoing Halneuron® Phase 2b chemotherapy induced neuropathic pain (“CINP”) study. The independent statistical review committee reviewed unblinded patient treatment data from the Phase 2b trial and concluded that Halneuron® treated patients are demonstrating separation from placebo treated patients in terms of pain improvement over the four-week study. Based on the current Phase 2b trial enrollment pace and the interim assessment results, the Company continues to expect to have top-line results available during Q3 2026. Current study patient enrollment trends are projected to provide statistical power of approximately 80% to 85% to detect a Halneuron® treatment difference. “We have long believed that Nav 1.7 sodium channel inhibition holds great promise for treating both chronic and acute pain,” said Greg Duncan, Dogwood Therapeutics Chief Executive Officer. “Extrapolation of the current Phase 2b study trends has the potential to represent the first statistically significant trial involving CINP patients under FDA chronic pain study guidance.” This preliminary evidence of a Halneuron® treatment effect is noteworthy as patients in the interim analysis population present an average duration of CINP of 5 years and 67% of patients that met entry criteria were also being treated with stable doses of other chronic pain medicines, including pregabalin, gabapentin, duloxetine, and opioids. In addition, the overall study dropout rate of approximately 4.4% is far below rates typically observed with other FDA approved chronic pain medicines. While still blinded, the Company believes these findings reaffirm the encouraging safety and tolerability profile of Halneuron® observed in previous clinical trials. “There are currently no approved therapies to treat the moderate-to-severe neuropathic pain that occurs following chemotherapy treatment,” said Dr. R. Michael Gendreau, Chief Medical Officer of Dogwood Therapeutics. “We are hopeful that positive outcomes in this ongoing Phase 2b trial will set the stage for a Phase 3 registration program in CINP, providing a needed therapeutic option for this patient population of cancer survivors.” About Halneuron® Our lead product candidate, 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. Success in this Phase 2b study will serve as the basis for the Company engaging FDA to align on the Halneuron® Phase 3 development program requirements. About Dogwood Therapeutics Dogwood Therapeutics (Nasdaq: DWTX) is a development-stage biopharmaceutical company focused on developing new medicines to treat pain and neuropathic disorders. The Dogwood research pipeline includes two first-in-class development candidates, Halneuron® and SP16 IV. Our lead product candidate, Halneuron®, is in Phase 2b development to treat pain conditions including the neuropathic pain associated with chemotherapy treatment. Halneuron® has been granted fast track designation from the FDA for the treatment of CINP. Halneuron® is a non-opioid, NaV 1.7 analgesic 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”). SP16 IV is a low-density lipoprotein receptor related protein-1 agonist (LRP1) with potential to treat neuropathy and prevent or repair nerve damage following chemotherapy. SP16 acts as an LRP1 agonist that in turn provides alpha-1-antitrypsin-like activity. Consistent with alpha-1-antitrypsin anti-inflammatory and immunomodulatory actions, SP16 preclinically demonstrated anti-inflammatory (analgesic) action via potential reductions in IL-6, IL-8, IL1B and TNF-alpha levels, as well as potential to repair damaged tissue via increases in pAKT and pERK that regulate fundamental processes like growth, proliferation and survival. The forthcoming SP16 IV Phase 1b CINP trial is fully funded by the National Cancer Institute. Dogwood Therapeutic’s largest shareholder is a member of CK Life Sciences Int’l., (Holdings) Inc., which is listed on the Hong Kong Stock Exchange (Stock code: 0775). 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 [email protected]
Investor releaseQuarter not tagged2025-11-06Dogwood Therapeutics Reports Third Quarter 2025 Financial Results
GlobeNewswire
Dogwood Therapeutics Reports Third Quarter 2025 Financial Results
- Enrollment to date of 100 patients, with 80 patients completing treatment in the ongoing Halneuron® Phase 2b trial, prespecified interim analysis remains on track for Q4 2025 release - - Secured exclusive worldwide, royalty free license to develop and commercialize SP16 as a synergistic and complementary pipeline treatment for cancer-related pain in an all-stock transaction - ATLANTA, Nov. 06, 2025 (GLOBE NEWSWIRE) -- Dogwood Therapeutics, Inc. (Nasdaq: DWTX) (the “Company”), a development-stage biotechnology company developing new medicines to treat pain and neuropathy, today announced financial results for the third quarter ended September 30, 2025. “The Company continues to execute at a high level, including recruitment of 100 patients in our ongoing Halneuron® Phase 2b trial and the addition of a, synergistic and complementary pipeline asset, SP16, a novel, first-in-class development candidate for cancer related pain,” said Greg Duncan, Chief Executive Officer of Dogwood Therapeutics. “We are excited for our journey ahead and look forward to delivering on our target milestones, including an update on our interim analysis on our Halneuron® CINP Phase 2b trial in Q4 2025, with final data for the full 200 patient data set expected in the second half of 2026, as well as garnering FDA feedback for our proposed SP16 Phase 1b study that is fully funded by the National Cancer Institute.” Third Quarter 2025 Financial Results Research and development expenses for the third quarter of 2025 were $14.5 million, compared to $0.5 million for the third quarter of 2024. The $14.0 million increase quarter over quarter was primarily related to acquired in-process research and development expenses of $12.0 million associated with the licensing agreement of SP16, the impact of the business combination with Pharmagesic (Holdings) Inc., including increases in expenses for clinical trials of $1.9 million related to the Halneuron® CINP Phase 2b study, as well as drug development and manufacturing costs of $0.3 million and salaries and related personnel costs of $0.1 million, offset by a decrease in research and preclinical costs of $0.3 million. General and administrative expenses for the third quarter of 2025 were $1.3 million, compared to $1.8 million for the third quarter of 2024. The $0.5 million decrease quarter over quarter was primarily due to a decrease in legal and ac…Read full documentShow less
- Enrollment to date of 100 patients, with 80 patients completing treatment in the ongoing Halneuron® Phase 2b trial, prespecified interim analysis remains on track for Q4 2025 release - - Secured exclusive worldwide, royalty free license to develop and commercialize SP16 as a synergistic and complementary pipeline treatment for cancer-related pain in an all-stock transaction - ATLANTA, Nov. 06, 2025 (GLOBE NEWSWIRE) -- Dogwood Therapeutics, Inc. (Nasdaq: DWTX) (the “Company”), a development-stage biotechnology company developing new medicines to treat pain and neuropathy, today announced financial results for the third quarter ended September 30, 2025. “The Company continues to execute at a high level, including recruitment of 100 patients in our ongoing Halneuron® Phase 2b trial and the addition of a, synergistic and complementary pipeline asset, SP16, a novel, first-in-class development candidate for cancer related pain,” said Greg Duncan, Chief Executive Officer of Dogwood Therapeutics. “We are excited for our journey ahead and look forward to delivering on our target milestones, including an update on our interim analysis on our Halneuron® CINP Phase 2b trial in Q4 2025, with final data for the full 200 patient data set expected in the second half of 2026, as well as garnering FDA feedback for our proposed SP16 Phase 1b study that is fully funded by the National Cancer Institute.” Third Quarter 2025 Financial Results Research and development expenses for the third quarter of 2025 were $14.5 million, compared to $0.5 million for the third quarter of 2024. The $14.0 million increase quarter over quarter was primarily related to acquired in-process research and development expenses of $12.0 million associated with the licensing agreement of SP16, the impact of the business combination with Pharmagesic (Holdings) Inc., including increases in expenses for clinical trials of $1.9 million related to the Halneuron® CINP Phase 2b study, as well as drug development and manufacturing costs of $0.3 million and salaries and related personnel costs of $0.1 million, offset by a decrease in research and preclinical costs of $0.3 million. General and administrative expenses for the third quarter of 2025 were $1.3 million, compared to $1.8 million for the third quarter of 2024. The $0.5 million decrease quarter over quarter was primarily due to a decrease in legal and accounting fees of $0.5 million and a decrease in expenses associated with being a public company of $0.2 million, offset by an increase in salaries and related personnel costs of $0.2 million. Net loss attributable to common stockholders for the third quarter of 2025 was $15.7 million, or $8.20 basic and diluted net loss per share, compared to a net loss attributable to common stockholders of $2.3 million, or $2.05 basic and diluted net loss per share, for the third quarter of 2024. Cash on hand of $10.1 million provides operational runway 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 neuropathic disorders. The Dogwood research pipeline includes two first-in-class development candidates, Halneuron® and SP16 IV. Our lead product candidate, Halneuron®, is in Phase 2b development 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. Halneuron® is a non-opioid, NaV 1.7 analgesic 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”). SP16 IV is a low-density lipoprotein receptor related protein-1 (LRP1) agonist with potential to treat neuropathy and prevent or repair nerve damage following chemotherapy. SP16 acts as an LRP1 agonist that in turn provides alpha-1-antitrypsin-like activity. Consistent with alpha-1-antitrypsin anti-inflammatory and immunomodulatory actions, SP16 preclinically demonstrated anti-inflammatory (analgesic) action via potential reductions in IL-6, IL-8, IL1B and TNF-alpha levels, as well as potential to repair damaged tissue via increases in pAKT and pERK that regulate fundamental processes like growth, proliferation and survival. The forthcoming SP16 IV Phase 1b CINP trial will commence following consultation with FDA and is fully funded by the National Cancer Institute. 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 [email protected] -Financial Tables Follow- DOGWOOD THERAPEUTICS Selected Financial Data (unaudited) Source: Dogwood Therapeutics, Inc.
Investor releaseQuarter not tagged2025-10-30Dogwood Therapeutics to Report Third Quarter 2025 Financial Results on Thursday, November 6, 2025
ACCESS Newswire
Dogwood Therapeutics to Report Third Quarter 2025 Financial Results on Thursday, November 6, 2025
ATLANTA, GA / ACCESS Newswire / October 30, 2025 / Dogwood Therapeutics, Inc. (Nasdaq:DWTX) (the "Company"), a development‐stage biotechnology company developing new medicines to treat pain and neuropathy, announced today that it will report third quarter 2025 financial results on Thursday, November 6, 2025, before the open of the financial markets. About Dogwood Therapeutics Dogwood Therapeutics (Nasdaq:DWTX) is a development-stage biopharmaceutical company focused on developing new medicines to treat pain and neuropathic disorders. The Dogwood research pipeline includes two first-in-class development candidates, Halneuron® and SP16 IV. Our lead product candidate, Halneuron®, is in Phase 2b development 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. Halneuron® is a non-opioid, NaV 1.7 analgesic 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"). SP16 IV is a low-density lipoprotein receptor related protein-1 (LRP1) agonist with potential to treat neuropathy and prevent or repair nerve damage following chemotherapy. SP16 acts as an LRP1 agonist that in turn provides alpha-1-antitrypsin-like activity. Consistent with alpha-1-antitrypsin anti-inflammatory and immunomodulatory actions, SP16 preclinically demonstrated anti-inflammatory (analgesic) action via potential reductions in IL-6, IL-8, IL1B and TNF-alpha levels, as well as potential to repair damaged tissue via increases in pAKT and pERK that regulate fundamental processes like growth, proliferation and survival. The forthcoming SP16 IV Phase 1b CINP trial is fully funded by the National Cancer Institute. 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…Read full documentShow less
ATLANTA, GA / ACCESS Newswire / October 30, 2025 / Dogwood Therapeutics, Inc. (Nasdaq:DWTX) (the "Company"), a development‐stage biotechnology company developing new medicines to treat pain and neuropathy, announced today that it will report third quarter 2025 financial results on Thursday, November 6, 2025, before the open of the financial markets. About Dogwood Therapeutics Dogwood Therapeutics (Nasdaq:DWTX) is a development-stage biopharmaceutical company focused on developing new medicines to treat pain and neuropathic disorders. The Dogwood research pipeline includes two first-in-class development candidates, Halneuron® and SP16 IV. Our lead product candidate, Halneuron®, is in Phase 2b development 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. Halneuron® is a non-opioid, NaV 1.7 analgesic 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"). SP16 IV is a low-density lipoprotein receptor related protein-1 (LRP1) agonist with potential to treat neuropathy and prevent or repair nerve damage following chemotherapy. SP16 acts as an LRP1 agonist that in turn provides alpha-1-antitrypsin-like activity. Consistent with alpha-1-antitrypsin anti-inflammatory and immunomodulatory actions, SP16 preclinically demonstrated anti-inflammatory (analgesic) action via potential reductions in IL-6, IL-8, IL1B and TNF-alpha levels, as well as potential to repair damaged tissue via increases in pAKT and pERK that regulate fundamental processes like growth, proliferation and survival. The forthcoming SP16 IV Phase 1b CINP trial is fully funded by the National Cancer Institute. 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. Contact: CORE IR (516) 222-2560 [email protected] SOURCE: Dogwood Therapeutics, Inc. View the original press release on ACCESS Newswire
Investor releaseQuarter not tagged2025-08-13Dogwood Therapeutics Reports Second Quarter 2025 Financial Results
GlobeNewswire
Dogwood Therapeutics Reports Second Quarter 2025 Financial Results
- 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 NaV 1.7 research pipeline to other forms of pain, including diabetic peripheral neuropathy, post herpetic neuralgia and acute surgical pain.” “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. “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. Patients who suffer from this condition illustrate the critical role NaV 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, NaV 1.7 inhibitor to treat pain conditions including the neuropathic pain associated with chemotherapy treatment. Halneuron® has been grant…Read full documentShow less
- 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 NaV 1.7 research pipeline to other forms of pain, including diabetic peripheral neuropathy, post herpetic neuralgia and acute surgical pain.” “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. “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. Patients who suffer from this condition illustrate the critical role NaV 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, 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. 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, NaV 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 [email protected] -Financial Tables Follow- Source: Dogwood Therapeutics, Inc.
Investor releaseQuarter not tagged2025-08-06Dogwood Therapeutics to Report Second Quarter 2025 Financial Results on Wednesday, August 13, 2025
GlobeNewswire
Dogwood Therapeutics to Report Second Quarter 2025 Financial Results on Wednesday, August 13, 2025
ATLANTA, Aug. 06, 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, announced today that it will report second quarter 2025 financial results on Wednesday, August 13, 2025 before the open of the financial markets. 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 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, contai…Read full documentShow less
ATLANTA, Aug. 06, 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, announced today that it will report second quarter 2025 financial results on Wednesday, August 13, 2025 before the open of the financial markets. 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 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. Contact: [email protected]

