MANE
Published on 05/12/2026 at 07:40 am EDT
Tomorrow's Aesthetic and Dermatological Solutions Today
Corporate Presentation
May 202C
MAY 2026
VDPHL01 is designed for potential indication-leading efficacy and tolerability
Baseline Month 6
Raise Hair Growth Ceiling
Improve Tolerability at Increased Exposures
Greater total minoxidil exposure designed for fast, consistent, and intense hair growth
Frontal
Profile minimizes cardiac side effects by avoiding peak minoxidil concentrations associated with cardiac AEs
No Risk of Hormonal Side Effects
Convenience and Marketability
Non-hormonal molecule avoids potential AEs associated with hormonal treatment options
Vertex
First oral treatment in nearly 30 years for males, and first ever for females; leverages administration route consistently preferred by patients
Product Well-Characterized by Phase 2/3 Data
Potential to be the only actively promoted branded treatment for PHL in the United States could allow patient and prescriber activation through marketing
The images used in this presentation will remain treatment group-blinded while the extension phase of Study '302' is ongoing, so images cannot be linked to a particular treatment group at this time. Individual results may vary.
3
MAY 2026
VDPHL01 represents a late-stage opportunity in PHL
Phase 3 registration-directed study in males
Parallel in-trial Phase 2 component to further assess patient reported outcome (PRO) endpoints in Studies 302 C 304
Positive topline data from Part A of Study '302' announced April 2026
Study 302
Phase 2/3 trial evaluated 51S VDPHL01 in males with pattern hair loss
Study 304
Phase 3 trial evaluating VDPHL01 in 552 males with pattern hair loss
Confirmatory Phase 3 registration directed study in males
Fully enrolled with 6-month topline Phase 3 readout anticipated in H2 2026
•
Parallel in-trial Phase 2 component to further assess PRO endpoints in the Phase
3 portion of the study.
Study is actively enrolling
Phase 3 registration-directed study in females
Study 306
Phase 2/3 trial evaluating VDPHL01 In ~ females with pattern hair loss
4
MAY 2026
PHL Market Overview and Potential Commercial Opportunity
5
MAY 2026
Pattern hair loss impacts 80 million people in the U.S.1
90
80
million total U.S. patients include 50 million men without a
80 new oral treatment in ~30 years and 30 million women with no FDA-approved oral treatment options
with PHL
Women
30M
Patients Affected in the U.S.1 (M)
70
60
50
50
40
50M
Men
with PHL
32
30
20
10
0
PHL Acne (All Ages) Atopic
Dermatitis (Eczema)
30
16
8
3
PHL (Women) Rosacea Psoriasis Vitiligo
MAY 2026
1American Academy of Dermatology. (n.d.). Skin conditions by the numbers. https://www.aad.org/media/stats/conditions/hair-loss
2 Source: Market research conducted November 2024; HCP n=150 patient n=410
~9%
of Patients
Satisfied with Current Treatment Options2
~46%
of Patients
Actively Seeking New Tx2
Current Treatment Limitations:
6
Limited FDA approved treatment options
No FDA-approved oral options for women
Inconvenient administration
Tolerability issues
Related to hormonal, mood, and cardiac side effects
Insufficient density of hair growth
Inconsistent results
Can lead to treatment cycling
Slow onset of hair growth
Clinically significant results not anticipated for 4-12 months
VDPHL01 Patient Population Segments
~15M
~80M1
PHL Patients in the US in 2023
~6M4-6
Not Addressable
~59M
~74M people
Actively Treating Not Treating & Other
~1M2
Rx Patients
~14M3
OTC
Treatment Naïve
Tried Treatment but Discontinued
four addressable segments
https://medlineplus.gov/genetics/condition/androgenetic-alopecia/ (last updated July 2023).
Symphony Health Data on Rx Oral Minoxidil, Finasteride, etc., November 2023.
Global News Wire - The Insight Partners projections.
MAY 2026
Prevalence and Patterns of Male Androgenetic Alopecia in Tarauni, Kano, Nigeria
https://pmc.ncbi.nlm.nih.gov/articles/PMC4533555/.
https://pmc.ncbi.nlm.nih.gov/articles/PMC2684510/.
7
Projected $30B1 global hair loss market is characterized by OTC and off-label saturation without patient satisfaction
2023 US Androgenetic Alopecia
~59M
Potential Users Not Actively Engaging in Hair Loss Products
~14M2
OTC Hair Regrowth Product Users
~1M3
Rx Hair Loss Users
Total Addressable Market (TAM)
1 The worldwide PHL commercial opportunity estimated by Global News Wire - The Insight Partners for 2028.
Signals Market Demand at Scale + Price Tolerance
1.5 million users, >50% of whom are women5 paying ~$1000 annually
→ demonstrates consumer
price tolerance
86%
Discontinuation Rate4 Highlights OTC Churn
Lack of compliance cited as #1 reason for discontinuation; low compliance in the absence of AEs points to challenges with the daily
Validates Willingness to Pursue Rx
Constrained by male-only indication safety concerns, efficacy ceiling, and lackluster marketing
Includes hair loss OTC treatment products, not Rx, Telehealth, procedural interventions, etc.
2 MedlinePlus.gov - Genetics, Androgenetic Alopecia, July 2023: 50M Men, 30M Women.
3 Symphony Health Data on Rx Oral Minoxidil, Finasteride, etc., November 2023.
4 Shadi Z. (2023). Compliance to Topical Minoxidil and Reasons for Discontinuation among Patients with Androgenetic Alopecia. Dermatology and therapy, 13(5), 1157-1169. https://doi.org/10.1007/s13555-023-00919-x
5 https://www.modernretail.co/marketing/nutrafol-launches-multi-channel-campaign-to-raise-awareness-for-mens-business/
6 https://pmc.ncbi.nlm.nih.gov/articles/PMC10149432/#CR5 - Minoxidil compliance and satisfaction
MAY 2026
commitment associated with adherence and dissatisfaction with results6
Grew Rx Weight-Loss Market ~10x to Date1
Established new consumer expectations around potential treatment outcomes
Rapidly C opportunistically scaled on commercial momentum and minimized friction
Chronic Aesthetic Management Drives ~$9.5B Facial Injectables Market2
Scaling of chronically managed aesthetic condition supports potential for rapid adoption and favorable adherence
Grew Rx Market 7x Within
1 Month of Launch3
Limited demand for ED treatments pre-Viagra Rx reflected existing product limitations (e.g. intracavernous injections) vs. addressable patient need
MAY 2026
1IǪVIA data sizes the pre-2020 global spend on weight loss at ~$3B; spending eclipsed $30B by 2024
2Market size in 2024: https://www.fortunebusinessinsights.com/industry-reports/facial-injectables-market-100603
3https://www.pharmexec.com/view/viagra-launch-commands-attention
Analogues support conversion of latent demand with product performance + emotional resonance
Minoxidil is a validated approach to treat hair loss in both males and females, but existing treatment approaches have inherent limitations
Topical Minoxidil (Rogaine) Immediate Release (IR) Oral Minoxidil
Messy and Cumbersome - Compliance, even in the absence of adverse effects, is frequently the reason for discontinuation of topical minoxidil1
Modest Efficacy - Topical application has modest efficacy due to the limited amount of minoxidil that makes it to the hair bulb
Lack of FDA approval - IR oral minoxidil is FDA approved as a treatment for refractory hypertension and has explicit labeling that it is not a treatment for hair loss
Dose-dependent cardiac risk - Dosing of IR oral minoxidil is limited by potential cardiac adverse events resulting in reduced potential efficacy for treatment of hair loss
Hair growth ceiling - potential mismatch between pharmacokinetic (PK) profile and what hair follicles require for hair growth. Off-label IR oral minoxidil has an efficacy ceiling on-par with topical minoxidil
1 https://pmc.ncbi.nlm.nih.gov/articles/PMC10149432/#CR5 - Minoxidil compliance and satisfaction
MAY 2026
Recent increase in prescribing low-dose oral minoxidil suggests pent-up demand in PHL market
500
450
400
Monthly Prescriptions (Thousands)
350
300
250
200
150
100
50
0
Monthly Total Minoxidil Prescriptions by Strength (U.S.)
Low-dose oral minoxidil
New York Times article on LDOM (August 2022)
MAY 2026
01/01/09 01/01/11 01/01/13 01/01/15 01/01/17 01/01/19 01/01/21 01/01/23 01/01/25
10MG 2.5MG
11
Source: Symphony claims data accessed via Bloomberg Health Terminal
Our Solution: VDPHL01
12
MAY 2026
VDPHL01's proprietary extended-release technology delivers a differentiated formulation of minoxidil intended to optimize efficacy and safety
Hair growth threshold (1.C2
ng/mL)
Ideal Minoxidil Plasma Concentration Target
Cardiac Activity Threshold (20 ng/mL)
VDPHL01 8.5 mg
Minoxidil 2.5 mg IR
Minoxidil 5 mg IR (Estimated)
First minoxidil extended-release tablet 25
Plasma Concentration (ng/mL)
and only oral minoxidil tablet positioned
for potential approval for the treatment of PHL 20
10x
10x difference between minoxidil hair growth 15
threshold and minoxidil cardiac activity threshold
MAY 2026
Blunted maximum observed concentration (Cmax) below FDA recognized cardiac activity threshold achieved by extended release is designed to avoid cardiac adverse effects compared to immediate release
VDPHL01 is designed to deliver nearly twice the total amount of minoxidil over 12h and maintains concentrations above the hair growth threshold twice as long vs. a 2.5 mg IR tablet*
10
5
0
0 2 4 6 8 10
Time after Dose (hours)
VDPHL01 8.5 mg curve represents average plasma concentrations for male patients (n=10) from Study ǪSC300720. Minoxidil 2.5 mg IR data represents average plasma concentrations for male patients (n=10) from Study ǪSC300720.
Minoxidil 5 mg IR data represents average plasma concentrations estimates using dose linear pharmacokinetics* of Minoxidil 2.5 mg IR data for male patients (n=10) from Study ǪSC300720.
*Per pharmacokinetics data from average plasma concentrations for male patients (n=10) from Study ǪSC300720 evaluating males taking VDPHL01 8.5mg and minoxidil 2.5 mg IR. 13
Minoxidil
1 Hair follicles contain the SULT1A1 sulfotransferase enzyme that locally
converts minoxidil to its active metabolite,
minoxidil sulfate
2
Hair growth is stimulated at low
plasma levels of minoxidil because of its
local metabolism to minoxidil sulfate at the hair bulb
2
VDPHL01 is
designed to increase the duration of exposure to metabolized minoxidil sulfate at the hair follicle
PARENT DRUG
ACTIVE DRUG
1
Minoxidil Sulfate
VDPHL01 is designed to optimize the consistency and duration of exposure to active minoxidil sulfate
MAY 2026
Minoxidil mechanism of action is capacity-limited and time dependent
VDPHL01 Late-Stage Male Clinical Development Program: Study 302 & Study 304
15
MAY 2026
Study 302 trial design
Actual Enrollment
51G subjects, randomized 2:2:1:1
Clinical Sites
44 U.S. sites
Study Population
Male subjects 18-65 years of age (inclusive) with mild-to-moderate PHL
Screening Period
Part A: Placebo Controlled Period (Months 1-6)
Part B: Treatment Extension Period (Months 7-12)
Follow-Up Period
Group 1: VHPHL01 8.5 mg BID
Group 2: VHPHL01 8.5 mg ǪD*
Group 3: Placebo BID
Other Efficacy Endpoints**
Group 1: VHPHL01 8.5 mg BID
Group 2: VHPHL01 8.5 mg ǪD
Group 3: VHPHL01 8.5 mg BID
Group 4: VHPHL01 8.5 mg ǪD
Co-Primary Efficacy Endpoints:
Changes from baseline in non-vellus TAHC using digital image analysis at Month 6
Proportion of subjects who
Change from baseline in non-vellus TAHC using digital image analysis at Months 2 and 4
Proportion of subjects who achieve treatment benefit, defined as a self-reported score of 'Improved' or 'Much Improved' at Months 2 and 4.
Proportion of subjects graded by investigators as achieving a response category of, defined as achieving a response category of "a little improved", "moderately improved", or "greatly improved" at Months 2, 4 and 6
Changes from baseline in non-vellus TAHW using digital image analysis at Months 2, 4 and 6
Proportion of subjects satisfied with treatment, defined as achieving a response category of "a little satisfied", "moderately satisfied", or "Very satisfied" at Months 2, 4 and 6
achieve treatment benefit, defined as a PRO response of "Improved" or "Much Improved" at Month 6
MAY 2026
ǪD: Daily Dosing TAHC: Target Area Hair Count TAHD: Target Area Hair Darkness
BID: 2x/day Dosing TAHW: Target Area Hair Width PRO: Proprietary patient reported outcomes (PRO) scale designed for the VDPHL01 clinical trials
*All patients take investigational product or matched placebo twice daily (2x VDPHL01; VDPHL01 + placebo; 2x placebo) 16
**List of other efficacy endpoints is not exhaustive but is representative of the defined per-protocol secondary efficacy endpoints
Patient-reported outcome (PRO)
VDPHL01 achieved highly statistically significant and highly clinically meaningful benefit on both co-primary endpoints in trials to date
Target area hair count (TAHC)
Patient tattooed for location replicability
TAHC co-primary endpoint leverages the only measurement methodology used for FDA approval in PHL since 1997
Digital analysis lines up consecutive images to ensure the same location is captured.
Hairs ≥30 μm in diameter are counted as being non-vellus.
Digital analysis algorithm discerns both increases in number and thickness of hairs.
Accuracy of analysis is ensured by utilizing counts from 2 separate technicians.
MAY 2026
PRO co-primary endpoint is evaluated using the Androgenetic Alopecia Impact Rating Score (AAIRS)
All photography is standardized and undergoes quality control to ensure consistent imagery and parting
Patients are shown full-size photographs at baseline and evaluated time points to directly assess changes to the severity of their PHL on a 7-point scale from 'Much Worsened' to 'Much Improved'
AAIRS 7-Point Scale
3 = MUCH IMPROVED
2 = IMPROVED
1 = A LITTLE IMPROVED
0 = NO CHANGE
-1 = A LITTLE WORSE
-2 = WORSE
-3 = MUCH WORSE
*Co-primary endpoint
Study 302 baseli
Stud
ne characteristics VDPHL01
8.5MG ǪD
y Participants 171
VDPHL01
8.5MG BID
175
Placebo
173
Total
51G
Mean (SD), Median
42.1 (10.1), 40
43.0 (10.7), 42
42.6 (9.6), 42
42.5 (10.1), 42
Age
Patients age 40+; n (%)
95 (55.6)
106 (60.6)
104 (60.1)
305 (58.8)
Minimum, Maximum
21, 63
19, 65
22, 65
19, 65
American Indian/ Alaska Native
3 (1.8)
3 (1.7)
4 (2.3)
10 (1.9)
Asian
13 (7.6)
9 (5.1)
12 (6.9)
34 (6.6)
Race
Black or African American
12 (7.0)
12 (6.9)
25 (14.5)
49 (9.4)
n (%)
Native Hawaiian or Pacific Islander
0
0
0
0
White
143 (83.6)
147 (84.0)
131 (75.7)
421 (81.1)
Multiple
0
4 (2.3)
1 (0.6)
5 (1.0)
Ethnicity
Hispanic or Latino
21 (12.3)
28 (16.0)
25 (14.5)
74 (14.3)
n (%)
Not Hispanic or Latino
150 (87.7)
147 (84.0)
148 (85.5)
445 (85.7)
Baseline Norwood
Type IIIv
87 (50.9)
79 (45.1)
91 (52.6)
257 (49.5)
Hamilton Severity
Type IV
46 (26.9)
55 (31.4)
46 (26.6)
147 (28.3)
n (%)
Type V
38 (22.2)
41 (23.4)
36 (20.8)
115 (22.2)
Additional Baseline Characteristics
Baseline Non-Vellus Hair Count; mean (SD), median
Hypertensive at Baseline; n (%)
157.8 (49.7), 157
98 (57.3)
151.6 (50.7), 151
84 (48.0)
147.9 (58.3), 145
96 (55.5)
-
278 (53.6)
MAY 2026
Both active arms of Study 302 showed statistically significant improvements in Target Area Hair Count (TAHC) at Month 6
Non-Vellus TAHC Increase
absolute; from baseline at Month 6
[p<.0001]
30.3
∆=23.1
33.0
∆=25.8
7.3
n=173
n=171
n=175
35 [p<.0001]
Non-Vellus TAHC Increase
30
25
20
15
10
5
MAY 2026
0
Placebo
VDPHL01
8.5mg ǪD
VDPHL01
8.5mg BID
19
[p<.0001]
30.3
∆=23.1
33
∆=25.8
Hair Count Increase (Placebo)
Hair Count Increase (Active)
20.G
∆=1C.2
21.1
∆=14.4
14.6
7.3
7.3
10
6.7
n=173
n=171
n=173
n=175
4.7
n=172
n=175
n=97
n=48
N/A
[n=33]
N/A
[n=50]
35 [p<.0001]
30
TAHC Increase
absolute; from baseline at Month 6
Non-Vellus TAHC Increase
25
20
15
10
5
0
VDPHL01
8.5mg ǪD
VDPHL01
8.5mg BID
Rogaine 5% Foam
(Males; Month 4)
Oral Finasteride 1mg IR Oral Minoxidil
IR Oral Minoxidil 5mg (JAAD)
MAY 2026
VDPHL01 Data are presented from active study arms of Study '302'. Rogaine 5% foam data are presented from Olsen et al. (2007). Oral finasteride data are presented from Piraccini et al. (2022). IR oral minoxidil JAMA Derm data are presented from Pehna (2024). IR oral minoxidil JAAD data are presented from Fonseca et al. (2026).
5mg (JAMA Derm)
Note: No head-to-head studies comparing VDPHL01 to finasteride or other forms of minoxidil have been conducted. The results of this retrospective post hoc cross-trial comparison may not be directly comparable. 20
Differences exist between trial designs and subject characteristics, and caution should be exercised when comparing data across unrelated studies.
VDPHL01 exceeded expectations on TAHC and has potential to establish a new bar for differentiated PHL treatments
MAY 2026
Disclaimer
Veradermics Inc. published this content on May 12, 2026, and is solely responsible for the information contained herein. Distributed via Public Technologies (PUBT), unedited and unaltered, on May 12, 2026 at 11:39 UTC.