Dogwood Therapeutics : Corporate Presentation (Dogwood Non Confidential Corporate Update May 2026)
DWTX
Published on 05/13/2026 at 10:10 am EDT
May 2026
NASDAQ: DWTX
Headquarters
Atlanta, GA
Nasdaq
DWTX
Shares Outstanding
33,629, 553
Cash
$13.2 million March 31, 2026 Pro forma
Analyst Coverage
H.C. Wainwright
Maxim Group
Pipeline History
Acquired Halneuron® (Wex Pharmaceuticals) Ǫ4 2024
Licensed in SP16 from Serpin Ǫ4 2025
Licensed out IMC-1/IMC-2 Ǫ2 2026
Team Introductions
Greg Duncan
Chairman & CEO
Ralph Grosswald
Senior VP, Operations
R. Michael Gendreau MD, PhD Chief Medical Officer
Scott Millard
VP Research
Angela Walsh
Chief Financial Officer
Jerry Evarts
VP Mfg
Proven Record of Drug Development & Commercial Success
The Problem of Neuropathic Pain
Neuropathy includes both acute and chronic pain-as well as a debilitating loss of function involving muscle weakness, tingling, and poor coordination, with significant impact on QoL
Approximately 7.5 million patients suffering from chemotherapy induced peripheral neuropathy (CIPN)
Over 3 million patients suffer from chemotherapy induced neuropathic pain (CINP)
Lead Assets Establish Beachhead
Lead asset Halneuron®targets the peripheral voltage-gated sodium channel NaV1.7 "off switch" at its source for treat moderate to severe CINP
SP16 activates LDL-receptor related protein 1 (LRP1) to drive pain reduction (anti-inflammatory) and reparative signaling to restore immune balance
Clinically Validated
Halneuron demonstrated statistically significant and durable pain reduction, with acceptable safety profile, in cancer and chemotherapy related clinical pain studies to date
2026 Catalysts
Halneuron in Phase 2b CINP development, data anticipated 3Q26
SP16 IND Accepted by FDA; Chemotherapy Induced Peripheral Neuropathy (CIPN) Phase 1b enrollment anticipated to commence mid-2026
Significant Opportunity
CINP treatment opportunity ~$3B market1
Expand into larger ~$7.5B Cancer Related Pain (CRP) market2
5
1Delve Insight 2Allied Market Research
Candidate
Indication
Preclinical
Phase 1
Phase 2
Phase 3
2026 Milestones
Halneuron® Injection
CINP
Ǫ2'26 P2b Study Commences (Part II)
Fast Track Designation
General Cancer Pain
Ǫ3'26 P2b Data Readout Ǫ4'26 EOP2 FDA Submission P2 Completed Demonstrated
Statistically Significant Pain Reduction
Acute Surgical Pain
SP16 IV
CIPPN
NCI Funded
IND Accepted by FDA
Ǫ3'26 P1b Commences Enrollment
Neuropathy Symptom Onset
Oncologist Treatment Considerations
Pain Specialist Call Point
Oncologists Market Development Opportunity
Patients Experience
Numbness
Tingling
Burning pain
Sensitivity to cold
Muscle weakness
Balance disturbance, and others
Mild - continue chemo + monitor
Moderate - dose reduction/delay
Severe - discontinue chemo
Focused on cancer remission, not treating pain
Anecdotally, pain treatments underutilized due to concerns about exposure to additional side effects
Post chemo chronic pain patients
Pain Specialist (i.e. Neurologist, anesthesiologists, etc.)
Treatment with "off-label" with chronic pain meds (duloxetine, pregabalin, opioids)
Current majority of sites for Phase 2b Trial are pain specialists
Oncologist treatment of pain represents growth option
Buy and bill model aligns well for injectable treatments
LCM expansion to general cancer related pain
There are > 3 Million Existing US CINP Patients
Annual Estimated Burden of New Cancer Type
Cancer Type
New Cases
Breast
313,310
Prostate
299,010
Lung
234,580
Colorectal
152,810
Skin
100,640
Bladder
83,190
Kidney
81,610
Non-Hod Lymphoma
80,620
Uterine
67,880
Pancreatic
66,440
Thyroid
44,020
Liver
41,630
Myeloma
35,780
Total New
2,003,140
2,003,140
57.7%
Treated of Cancer Patients Treated with Chemo
~70%
Exhibit/Developing Moderate-to-Severe Neuropathy
1,154,658
~41%
Exhibit Painful Neuropathy
808,260
331,387
New Moderate/Severe CINP Patients/Annum
No FDA-approved therapies currently exist for CINP
Eleven of twelve prior CINP trials failed
Duloxetine recommended by ASCO for CINP, despite mixed clinical results
Off label used chronic drugs have proven ineffective
50+% patients in our study are currently on chronic pain meds (i.e. duloxetine, pregabalin or opioids) yet still qualify as having moderate to severe pain
CINP market opportunity for Halneuron
Current opportunity: ~3.08 million patients represents a ~$3B US opportunity
Worldwide incidence of cancer is projected to 26 million by 2040 (+53%)
G
Sources: American Cancer Society: Discovery Dundee: Neurology Advisor: CancerWorld2019: Lancet, Oncology, 2019; Delveinsight December 2018; Chemotherapy-Induced Peripheral Neuropathy, Market insights, Epidemiology and Market Forecast 2018-2027; Allied Market Research December 2018; Global Cancer Pain Market, Opportunity Analysis and Industry Forecast 2018-2025; LP Information December 2019, Global Pain Management Drugs Market growth 2019 -2024; Windbank, Annals pf Neurol, Naurol, 2017; Cancer facts C Figures 2021, CA: A Cancer Journal for Clinician
Total Market Sales ($M) Market Share (%) by Therapy in the 7MM, 202C
5% 3%
7%
14%
46%
25%
$3,832B Projected
$126
$347
$542
$319
$848
$2,665
$1,015B
2025 2036
Halneuron® CINP
Halneuron® is Tetrodotoxin (TTX), a voltage-gated sodium channel blocker and potent small molecule found in puffer fish and several other marine animals (not a peptide or protein)
Prevents or relieves pain by interrupting nerve conduction
Modulates pain transmission in the peripheral nerves, no CNS effects
Administered as a sub-Ǫ injection
How Does Halneuron® Work?
Halneuron® works as an analgesic by binding the Nav1.7, channel, a sodium channel responsible for pain signal transmission and associated with certain neuropathies.
Channel
TTX sensitivity
Predominant distribution
Nav1.7
EC50= 24.5 nM
PNS (DRG)
Nav1.8
EC50 = 60 µM
PNS (DRG)
Nav1.9
EC50 = 40 µM
PNS (DRG)
TTX preferentially acts to block pain signals through Nav1.7
TTX unable to cross the blood-brain barrier
Relief of chronic pain without the common CNS side effects
Loss of NAV1.7 Function Leads to Congenital Insensitivity to Pain Syndrome
Compared
30 µg BID x 4 days
Placebo BID x 4 days
A "Responder" was defined as a patient who had a mean reduction in pain intensity of ≥ 30%; or ≥ 50% reduction in opioid use
Conclusions
Halneuron® treatment demonstrated statistically significant reduction in cancer related pain
Halneuron® treatment reduced both neuropathic and non-neuropathic pain
Mean Pain Response For Halneuron® Responders Was
57.7 Days Vs 10.5 Days For Placebo Responders
Halneuron® Responders
0
10 20 30 40 50 60 70 80
90 100
Days
150 200 250 300 350 400 450 500 550
One-in-four (27%) Halneuron® responders had pain relief for
>30 days after 4 days of treatment
Placebo Responders
0
10 20 30 40 50 60 70 80 90
100
Days
150 200 250 300 350 400 450 500 550
Placebo response was temporary
A "Responder" was defined as a patient who had a mean reduction in pain intensity of ≥ 30%; or ≥ 50% reduction in opioid use
Randomized, double-blind, dose-finding, placebo-controlled, multicenter study evaluating efficacy and safety of Halneuron® in CINP patients (n=125)
sub-Q injections in patients with neuropathic pain
7.5 µg
15 µg
30 µg
30 µg results superior to lower doses and placebo
30 µg BID vs QD showed comparable efficacy (with half the total amount of drug delivered)
30 µg QD demonstrated a superior adverse event profile to BID dosing
Halneuron® showed an acceptable safety profile in CINP patients, similar to that seen in CRP
30 µg BID x 4 days
30 µg ǪD x 4 days
Doses Tested
Compared
Results
Placebo x 4 days
15 µg BID x 4 days
7.5 µg BID x 4 days
Conclusions
30 µg dosed 1x day selected to advance to Phase 2b studies in CINP
Determined treatment 'effect size' used to power the Phase 2b study (i.e 0.4) through interim assessment
4 Week Phase 2b Study
Primary Objective to explore the safety and efficacy of Halneuron® in the treatment of patients with moderate-to-severe CINP
Halneuron ǪD
Placebo ǪD
R
BL
Screening & Randomization
Run in Period
Treatment Phase
8 injections administered over 2 weeks
Endpoints (Week 4)
Change from Baseline in the weekly average of daily 24-hour pain
Incidence of SAEs, AEs, and AESIs
Interim Results
Days -7 to -1
Week 1
Week 2
Week 3
Week 4
EOS
Final Phase 2b Study
(HALT-CINP-203)
Data Projected Fall 2026
Completed Phase 2b interim analysis for sample size and to choose the analytical method for the
primary analysis for the statistical analysis plan
Committee consists of two senior statisticians not otherwise involved with our study
Interim analysis based on change in pain from baseline compared to placebo:
Statistical methodology based on >50% responder analysis
Sample size required to maintain 80-85% statistical power ranges from 210 to 240 patients
Key Highlights (n=97)
Halneuron demonstrating treatment effect versus placebo
Responders exhibit durable treatment pattern
Halneuron treatment effect +/- concomitant pain meds also > placebo
Halneuron drop out rate (~4.4%) far below other compounds: duloxetine (20+%), pregabalin (30-40%)
Halneuron treatment effect noteworthy given:
5-year (mean) duration of moderate-to-severe neuropathic pain for Ph2b enrollees
Includes refractory CINP patients treated with other chronic pain medicines (67%)
First randomized control clinical trial to demonstrate pain reduction effect in CINP patients conducted under FDA chronic pain guidance
Second cancer related pain trial exhibiting pain reduction via responder analysis
Final Data Projected Fall 2026
Adverse Event (AE)
CINP 201
TTX 30 µg ǪD x 4 days N=25 N (%)
CINP-201
Placebo x 4 days N=25 N (%)
CINP-203 Currently Blinded Summary:
TTX 30µg ǪD x 8 days Combined Drug + Placebo
N=125 (%)
Paresthesia oral (tingling or sensation in oral region)
10 (40.0%)
3 (12.0%)
51 (41%)
Hypoesthesia oral (numbness or decreased sensation in oral region)
6 (24.0%) 3 (12.0%) 24 (1G%)
Paresthesia (tingling or sensation in extremities)
5 (20.0%)
6 (24.0%)
23 (18%)
Headache
1 (4.0%)
5 (20.0%)
17 (14%)
Nausea
1 (4.0%)
6 (24.0%)
16 (13%)
Fatigue
5 (20.0%)
4 (16.0%)
G (7%)
Dizziness
3 (12.0%)
5 (20.0%)
6 (5%)
Dysgeusia (taste distortion)
2 (8.0%)
0 (0%)
4 (3%)
Pain in extremity
4 (16.0%)
2 (8.0%)
2 (1.6%)
Burning sensation
1 (4.0%)
2 (8.0%)
2 (1.6%)
Back pain
1 (4.0%)
3 (12.0%)
0 (0%)
Halneuron has appeared to be safe and well tolerated across multiple clinical trials to date, with oral paresthesia being the most common, yet transient adverse effect
12 Week Open Label Study
3 Dosing Intervals
Interval 1 (E1) Interval 2 (E2) Interval 3 (E3)
Injections: Week 1 Injections: Week 5 Injections: Week 10
2 injections: E1a, E1b
2 injections: E2a, E2b
2 injections: E3a, E3b
Screen
(if not a rollover)
EOS
or or or
4 injections: E1a, E1b, E1c, E1d
4 injections: E2a, E2b, E2c, E2d
4 injections: E3a, E3b, E3c, E3d
Visit E0
Week 1 to Week 4
Week 5 to Week 9
Week 10 to Week 12
Visit E4
Commenced Enrollment May 2026
Patients will continue daily pain diaries entry scores
IRT will assign either 2 or 4 injections for the interval, based on 7-day average pain scores
Halneuron® dosing as follows:
NRS Pain Change > 4 gets 4 injections at treatment interval, or
NRS Pain Change <3 gets 2 injections at treatment interval
Disclaimer
Dogwood Therapeutics Inc. published this content on May 13, 2026, and is solely responsible for the information contained herein. Distributed via Public Technologies (PUBT), unedited and unaltered, on May 13, 2026 at 14:09 UTC.