Dermata Therapeutics, Inc. · NASDAQ:DRMA
Dermata Therapeutics — IPO Roadshow (July 2021)
31 slides from Dermata Therapeutics's IPO roadshow presentation, Jul 12, 2021
Slide 1: Dermata Therapeutics: Transforming topical treatment of the skin
Dermata Therapeutics Transforming topical treatment of the skin Corporate Presentation July 2021 Filed pursuant to Rule 433 of the Securities Act of 1933 Issuer Free Writing Prospectus dated July 12, 2021 Relating to the Preliminary Prospectus dated June 10, 2021 Registration Statement No. 333-25699
Slide 2: Cautionary Note on Forward Looking Statements and Disclaimers
We have filed a registration statement on Form S-1 (including a preliminary prospectus) with the SEC for the offering to which this presentation relates. The registration statement has not yet become effective. Before you invest, you should read the preliminary prospectus in the registration stateme
Slide 3: Corporate Highlights
Corporate Highlights Unique, multi-use topical platform technology utilizing multiple mechanisms of actions Lead program with compelling Phase 2b clinical data for once-weekly topical treatment of acne Pipeline addressing large medical and aesthetic dermatology market opportunities Multiple clinical
Slide 4: Experienced Management Team
Gerry Proehl – Founder, Chairman and President & CEO Former Founder, President & CEO, Santarus prior to sale to Salix Pharmaceuticals for $2.6 billion, VP, Global Marketing, Hoechst Marion Roussel (now part of Sanofi) Tom Insley – Chief Financial Officer Former CFO, SkinMedica; Former Managing Partn
Slide 5: Board of Directors
Gerry Proehl – Founder, Chairman and President & CEO Former Founder, President & CEO, Santarus prior to sale to Salix Pharmaceuticals for $2.6 billion; Former VP, Global Marketing, Hoechst Marion Roussel (now part of Sanofi) David Hale – Founder and Lead Director Chairman & CEO, Hale Bioventures; Fo
Slide 6: Unique Pipeline Addressing Medical Dermatology & Aesthetics
Program Preclinical Phase 1 Phase 2 Phase 3 Anticipated Milestone DMT310 Acne P3 Planned – H2’22 Psoriasis P1b PoC Initiated – Q1‘21 Rosacea P2 Planned – H2’21 DMT410 Hyperhidrosis P1b PoC Completed Aesthetics P1b PoC Results – Q3’21 The FDA allowed Dermata to proceed directly to a Phase 2 trial in
Slide 7: Acne, Psoriasis, Rosacea and Aesthetics Market Opportunities
Acne 50 million US patients have acne, with about 85% of teenagers experiencing some form of acne 1 The prescription acne market saw about $2.3 billion in sales in 2019 2 There have been few novel topical treatments approved in recent years, with most new products being reformulations of old compoun
Slide 8: Unique Natural Platform Technology
Complex freshwater sponge, Spongilla lacustris or Spongilla, harvested based on proprietary environmental conditions resulting in unique characteristics that are optimized for clinical applications Possesses multiple complementary chemical and mechanical properties to potentially enhance pharmaceuti
Slide 9: Dual Mechanisms of Action
Chemical Components: Contains multiple chemical compounds that have demonstrated in-vitro: Anti-inflammatory activity: Reduction of C. acnes stimulated IL-8 production in NHEK inhibits IL-17A and IL-17F expression in human cell lines Anti-microbial activity against C. acnes Effects on sebum producti
Slide 10: Regulatory, Commercialization, Patents and Raw Material Supply
Regulatory Planning to seek new drug exclusivity – 5 years No clear regulatory pathway for abbreviated NDAs (New Drug Applications) for approved botanical NDAs Commercialization of DMT310 Option to seek Rx-to-OTC switch after 5 years, due to safety and market for DMT310 resulting in substantially la
Slide 11: Development Timeline & Milestones
Development Timeline & Milestones *PoC: Proof of Concept Q1’21 Q3’21 H2’21 H1’22 H2’22 H1’23 H1’24 H2’24 Phase 1b PoC Psoriasis Trial Initiated Phase 1b PoC Facial Aesthetics Trial Results Initiate Phase 2 Rosacea Trial Phase 1b PoC Psoriasis Trial Results Initiate Phase 2 Psoriasis Trial Phase 2 Ro
Slide 12: DMT310: Once-weekly topical treatment
DMT310: Once-weekly topical treatment
Slide 13: DMT310 Potential Advantages: Frequency, Time to Effect, Tolerability
Frequency of treatments Current topical treatments are onerous and require 1-2 applications per day, resulting in poor compliance and early discontinuation by patients We believe DMT310 (once-weekly application) could optimize compliance Time to treatment effect Current topical treatments may take 6
Slide 14: Application of DMT310
Once per week, patients mix the powder with hydrogen peroxide, and massage the mixture onto their skin; after 10-15 minutes the product is easily removed with water Sponge is processed into a fine powder and packaged into 2g pouches with a 6mL bottle of 3% H2O2 Application of DMT310
Slide 15: DMT310 Phase 2b Trial: Moderate-to-Severe Acne
Study Design: Double-Blind, Randomized, Placebo Controlled 2 Groups – DMT310 + H2O2 and Placebo + H2O2 181 patients enrolled at 14 sites in US with IGA baseline score of 3 or 4 12 years and older 12-week duration Once-weekly application Endpoints: Absolute Reduction in Inflammatory Lesion Counts Abs
Slide 16: Phase 2b Results: Reduction in Inflammatory Acne Lesions
Mean Change from Baseline - Inflammatory Lesion Count Percent Change from Baseline - Inflammatory Lesion Count Phase 2b Results: Reduction in Inflammatory Acne Lesions
Slide 17: Phase 2b Results: Non-Inflammatory Acne Lesions
Mean Change from Baseline Non-Inflammatory Lesion Count Percent Change from Baseline Non-Inflammatory Lesion Count Phase 2b Results: Non-Inflammatory Acne Lesions
Slide 18: Phase 2b Results: Investigator Global Assessment
* p < 0.05 ** p < 0.01 Responder: IGA 2-grade change AND IGA=0 or 1 Phase 2b Results: Investigator Global Assessment
Slide 19: Phase 2b Results: Treatment Emergent Adverse Events
DMT310 (N=91) N (%) Placebo (N=90) N (%) General disorders and administration site conditions 5 (5.5) 2 (2.2) Application site erythema 4 (4.4) 1 (1.1) Application site pruritus 2 (2.2) 2 (2.2) Application site dryness 1 (1.1) 0 (0.0) Application site exfoliation 1 (1.1) 0 (0.0) Phase 2b Results: Tr
Slide 20: Phase 2b Results: Local Tolerability
Phase 2b Results: Local Tolerability
Slide 21: DMT310 Phase 1b Trial: Mild-to-Moderate Psoriasis (Ongoing)
Study Design: Phase 1b Proof-of-Concept, open label study DMT310 + H2O2 30 patients enrolled at 3 sites in US with psoriatic plaque covering 2% to 30% of BSA 18 years and older 12-week duration Once-weekly application Endpoints: 6-point Investigator’s Physician’s Global Assessment (PGA) at the targe
Slide 22: DMT310 Phase 2 Trial: Moderate-to-Severe Rosacea (Planned)
Study Design: Double-Blind, Randomized, Placebo Controlled 2 Groups – DMT310 + H2O2 and Placebo + H2O2 180 patients enrolled at 24 sites in US with IGA baseline score of 3 or 4 18 years and older 12-week duration Once-weekly application Endpoints: Absolute Reduction in Inflammatory Lesion Counts Inv
Slide 23: DMT410: enabling topical application of botulinum toxin
DMT410: enabling topical application of botulinum toxin
Slide 24: DMT410's Combination Regimen for Botulinum Toxin
*Spicules average about 200 µm in length, 10-15 µm in diameter Adapted from Zheng et al Biomater. Sci. 2019; 7 (4): 1299-1310 Botulinum toxin (>100 kD) Spicule creates microchannel for topical application of toxin DMT410 is a combination treatment regimen that uses sponge technology to allow for nee
Slide 25: Application of DMT410
Sponge mixture is massaged into the treatment area to enhance spicule penetration and create microchannels After 10-15 minutes the sponge mixture is removed Then botulinum toxin is expressed from a syringe in precise amounts onto the skin and massaged into the treatment area to take advantage of the
Slide 26: DMT410 Potential Advantages: Molecule Size, Coverage, Additional Uses
Molecule Size Botulinum toxin molecules are between 400-900 kDa and are currently injected for clinical efficacy We believe DMT410 creates microchannels in the skin that are large enough to allow topical penetration of botulinum toxin into the dermis for targeted treatment Increased Coverage Current
Slide 27: DMT410 Phase 1b Trial: Axillary Hyperhidrosis
Study Design: Open-label, 2-arm study 2 Groups – DMT410 + H2O2 and DMT410 + H2O 10 patients enrolled at 1 site in US At least 18 years of age DMT410: One application of sponge powder, followed by one topical application of BOTOX® 4-week duration Endpoints: Percent of patients with ≥50% reduction in
Slide 28: Phase 1b Results: Reduction in Sweat Production
Endpoints at 4 weeks DMT410 n=20* Response Rate Decrease in gravimetric sweat production ≥ 50% 80% Gravimetric sweat production <50mg 85% Change in gravimetric sweat production -75% *Each patient contributed 2 axillae to the analysis; 1 axilla received DMT410+ H2O2 & 1 axilla received DMT410+ H2O -
Slide 29: DMT410 Phase 1b Trial: Facial Aesthetics (Ongoing)
Study Design: Open-label, 1-arm study 10 patients enrolled at 1 site in US One application of sponge mixture, followed by 1 topical application of BOTOX® At least 18 years of age Patients will be assessed at 4 weeks, 8 week, 12 weeks and 16 weeks post application Endpoints: Moderate to severe glabel
Slide 30: Corporate Highlights
Corporate Highlights Unique, multi-use topical platform technology utilizing multiple mechanisms of actions Lead program with compelling Phase 2b clinical data for once-weekly topical treatment of acne Pipeline addressing large medical and aesthetic dermatology market opportunities Multiple clinical
Slide 31: Dermata Therapeutics: Transforming topical treatment of the skin
Dermata Therapeutics Transforming topical treatment of the skin