Exhibit 99.1
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Legal Disclaimer This presentation of Pelthos Therapeutics Inc. (“we”, “us”, “our” or the “Company”) contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act and other securities laws. Words such as “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict, “project,” “seek,” “should,” “target,” “will,” “would” or similar expressions and the negatives of those term are intended to identify forward-looking statements. Forward-looking statements reflect management’s current expectations, are based on judgments and assumptions, are inherently uncertain and are subject to risks, uncertainties and other factors, which could cause the Company’s actual results, performance or achievements to differ materially from expected future results, performance or achievements expressed or implied in those forward-looking statements. Examples of these forward-looking statements and the related risks, uncertainties and other factors include, but are not limited to, the following: the success of the launch for Zesluvmi, timing, progress and results of any preclinical and clinical trials, its estimates regarding the potential market opportunity for Zelsuvmi, its ability to develop its pipeline, its ability to protect its intellectual property and enforce its intellectual property rights, and its ability to execute its development strategy and sustain its competitive position. Actual future results and trends may differ materially depending on a variety of factors, including, but not limited to, the Company’s limited operating history, the Company’s ability to establish its market development capabilities to commercialize its products and generate any revenue, and the Company’s ability to maintain regulatory approval of Zelsuvmi. Forward-looking statements are provided to allow potential investors the opportunity to understan management’s beliefs and opinions in respect of the future so that they may use such beliefs and opinions as one factor in evaluating an investment. These statements are not guarantees of future performance and undue reliance should not be placed on them. Any forward-looking statement in this presentation, in any related presentation supplement and in any related free writing presentation reflects our current view with respect to future events and is subject to these and other risks, uncertainties and assumptions relating to our business, results of operations, industry and future growth. You should read this presentation with the understanding that our actual future results may be materially different from any future results expressed or implied by these forward-looking statements. Except as required by law, we assume no obligation to update or revise these forward-looking statements for any reason, even if new information becomes available in the future. 2
Corporate Profile Pelthos Therapeutics is a bio-pharmaceutical company committed to commercializing innovative, safe, and efficacious therapeutic products to help patients with unmet treatment burdens Commercial launch of first drug Zelsuvmi, for the treatment of Molluscum contagiosum (“MC”) in July 2025 First and only at home treatment for a large, underserved market treating contagious viral disease 16.7 million affected people Up to 6 million annual cases in the U.S. Total addressable market worth in excess of $20 billion at our WAC Experienced management team with over 20 successful prior drug launches and continued growth, including Cosentyx, Otezla, Ohtuvayre, Xifaxan Upside option on NaV pain programs from predecessor Current peak Net Revenue forecast of $175M per annum by 2028 and currently meeting or exceeding internal milestones Key Data Points (as of 08/29/25, except where noted) Ticker PTHS Stock Price $23.65 O/S Shares of 8.8M Common Stock (on an as converted basis)* Market CAP ~$205M Avg. Daily 59000 shares 12,300 shares Trading Volume Cash at close of $27.5M merger Investment to >$400M date 3
Management Team Scott Plesha | Chief Executive Officer • >30 years of experience in the pharmaceutical industry, including two decades building and leading specialty pharma commercial efforts • President and Chief Commercial Officer at BDSI until it was acquired by Collegium Pharmaceutical in 2022 • Grew BDSI sales from $5 million to $160 million • Previously served as Senior Vice President of Gastrointestinal Sales at Salix Pharmaceuticals. During fifteen-year tenure at Salix, led nationwide salesforce that grew product sales to more than $1.5 billion annually • Earned a BA in Pre-Medicine and Pre-Medical Studies at DePauw University and pursued graduate studies in Dentistry at Indiana University Dental School Frank Knuettel | Chief Financial Officer • 30 years of management experience in growing early-stage companies • Raised more than $400 million via venture, public equity and debt offerings and managed more than 15 mergers and acquisition transactions along with large-scale licensing transactions with fortune 50 companies • Holds numerous board positions, at both public and private companies, including Etheros Pharmaceuticals • Earned an MBA from The Wharton School and a BA from Tufts University Sai Rangarao | Chief Commercial Officer • >18 years of experience leading, launching, and marketing pharmaceutical products • VP of Marketing & Head of Neurology Sales at Collegium Pharmaceutical • VP of Marketing & Commercial Operations at BDSI, until it was acquired by Collegium in 2022 • Head of US Dermatology Marketing for Otezla at Celgene leading to acquisition by Amgen for $13 Billion • Member of the commercial and marketing organization at Novartis Pharmaceuticals that launched COSENTYX® in the U.S • Earned an MS in Bioscience Regulatory Affairs from The Johns Hopkins University, an MBA and MS from the New Jersey Institute of Technology, and a BS in Computer Science from Indiana University of Pennsylvania 4
Board of Directors Peter Greenleaf, Chairman Richard Baxter Todd Davis Ezra Friedberg Richard Malamut , MD Matt Pauls Scott Plesha 5
Molluscum & Zelsuvmi Overview
7 Molluscum Contagiosum A highly infectious viral condition primarily affecting children 1 year of age or older There are four known types of MC virus (MCV1, 2, 3, 4) with MCV1 being the most common1 Molluscum Contagiosum is caused by a pox virus and is characterized by small, round, firm, umbilicated, often painless bumps. Even after healing, re-infection is possible if in contact with an infected person or object4. ~17 million people infected in the U.S. MC can take up to five years to resolve without treatment2 Peak incidence between 1-10 years of age. Up to 73% of children go untreated3 Point prevalence of 3-6 million children (ages 0-16) in the U.S. Infection, Persistence, and Spread Visible and Psychological Impacts Pain & Skin Irritation Auto- inoculation2 Highly contagious to others ↑ risk of secondary bacterial infections2 Potential worsening of atopic dermatitis Itching, redness Inflammation Anxiety Social withdrawal Untreated Molluscum Contagiosum Has Severe Effects 1) Hebert AA, Bhatia N, Del Rosso JQ. Molluscum Contagiosum: Epidemiology, Considerations, Treatment Options, and Therapeutic Gaps. J Clin Aesthet Dermatol. 2023 Aug;16(8 Suppl 2):S4-S11. PMID: 37636018; PMCID: PMC10453394. 2.)Ludmann P. American Academy of Dermatology. Molluscum contagiosum. 4 October 2023. 3) Basdag H, Rainer BM, Cohen BA. Molluscum contagiosum: to treat or not to treat? Experience with 170 children in an outpatient clinic setting in the northeastern United States. Pediatr Dermatol. 2015;32(3):353-357. doi:10.1111/pde.12504. 4) Schaffer JV, Berger EM. Molluscum Contagiosum. JAMA Dermatol. 2016;152(9):1072. doi:10.1001/jamadermatol.2016.2367. 5) CDC. Clinical Overview of Molluscum Contagiosum. Jan 2025
8 Zelsuvmi Has the Potential to Shift MC Treatment Paradigm Zelsuvmi Current Options Painful, destructive treatments3 Attractive safety profile demonstrated in clinical trials with no / minimal scarring5,6 Remaining treatment options such as off-label drugs / natural remedies have unproven efficacy4 Demonstrated, proven efficacy across key primary and secondary endpoints in clinical trials6 Necessitates travel to HCP offices, adding to the time burden for MC patients and caregivers2 First FDA approved medication for molluscum that can be applied at home by patients or caregivers5 Other available topical treatment requires in-office visits every 3 weeks2 Daily application that can be started immediately 58.1% Mean MC Lesion reduction count(1) Breakthrough Product, Breakthrough Results 1.)Least-squares mean count reduction. See Figure 9: Browning JC, Hebert A, Enloe C, Cartwright M, Maeda-Chubachi T. Berdazimer Gel 10.3% is a Clinically Meaningful Therapeutic Intervention for Molluscum Contagiosum. Abstract and poster presented at Fall Clinical 2024. Las Vegas, NV. October 24-27, 2024. 2.) Eichenf ield LF, Kwong P, Gonzalez ME, et al. Safety and Efficacy of VP-102 (Cantharidin, 0.7% w/v) in Molluscum Contagiosum by Body Region: Post hoc Pooled Analyses from Two Phase III Randomized Trials. J Clin Aesthet Dermatol. 2021;14(10):42-47. 3.) Hebert AA, Bhatia N, Del Rosso JQ. Molluscum Contagiosum: Epidemiology, Considerations, Treatment Options, and Therapeutic Gaps. J Clin Aesthet Dermatol. 2023;16(8 Suppl 1):S4-S11. 4.) Ong SK, Hoft I, Siegfried E. Analysis of over-the-counter products marketed to treat molluscum contagiosum. Pediatr Dermatol. 2021;38(5):1400-1403. doi:10.1111/pde.14776. 5.) Zelsuvmi Package Insert. 6.) Sugarman JL, Hebert A, Browning JC, et al. Berdazimer gel for molluscum contagiosum: An integrated analysis of 3 randomized controlled trials. J Am Acad Dermatol. 2024;90(2):299-308. doi:10.1016/j.jaad.2023.09.066Ong
9 Intervention Population Key Study Highlights B-SIMPLE4 Primary Outcome B-SIMPLE4 Study Locations Zelsuvmi Efficacy Shown in Phase 3 Clinical Trials Drives Commercial Launch 808 Males, 790 Females Immunocompetent children and adults aged ≥6 months with 3-70 raised MC lesions Mean age: 6.7 years (Range: 0.9 – 76.6 years) 1,598 participants randomized 917 - Zelsuvmi Topical, once-daily application of Zelsuvmi (berdazimer gel, 10.3%) to all active MC lesions for up to 12 weeks 681 - Vehicle Topical, once-daily application of vehicle control gel to all active MC lesions for up to 12 weeks Patients who applied Zelsuvmi for 12 weeks achieved a mean and median reduction in lesion count of 58% and 82%, respectively, compared to 36% and 43% for patients who applied a vehicle control gel Mean Lesion Count Reduction(1) 55 Clinics across the US 32.4% of patients treated with Zelsuvmi achieved complete clearance of MC lesions at week 12, compared to 19.7% of patients treated with vehicle control gel in the BSIMPLE-4 pivotal Phase 3 trial Median Lesion Count Reduction(1) Safety Application site reactions were the most common adverse reaction associated with Zelsuvmi Common application site reactions included mild pain and mild erythema (caused by increased blood flow) Minimal scarring incidences witnessed 1) p-value <0.0001, favoring Zelsuvmi .. Source: Sugarman JL, Hebert A, Browning JC, Paller AS, Stripling S, Green LJ, Cartwright M, Enloe C, Wells N, Maeda-Chubachi T. Berdazimer gel for molluscum contagiosum: An integrated analysis of 3 randomized controlled trials. J Am Acad Dermatol. 2023 Oct 5:S0190-9622(23)02890-6. doi: 10.1016/j.jaad.2023.09.066.Epub ahead of print. PMID: 37804936. 58.1% 35.7% Zelsuvmi Control 82.4% 42.6% Zelsuvmi Control
10 CONFIDENTIAL Baseline Week 2 Week 4 0.0% -1.1 % -43.5% Week 8 -35.7% Week 12 -59.4% -82.4% -42.6% -10.7% - 25 .1% -9.0% -21 .6% - 58 .1% Baseline Week 2 Week 4 0.0% 0.0% -9.5% -10.0% -28.6% -27.8% Week 8 Week 12 Phase 3 Trial Results 1) Figure 9: Browning JC, Hebert A, Enloe C, Cartwright M, Maeda-Chubachi T. Berdazimer Gel 10.3% is a Clinically Meaningful Therapeutic Intervention for Molluscum Contagiosum. Abstract and poster presentedatFall Clinical 2024. Las Vegas, NV. October 24-27, 2024. 2) Figure 10: Browning JC, Hebert A, Enloe C, Cartwright M, Maeda-Chubachi T. Berdazimer Gel 10.3% is a Clinically Meaningful TherapeuticIntervention for Molluscum Contagiosum. Abstract and poster presented at Fall Clinical 2024. Las Vegas, NV. October 24-27, 2024. Least Squares Mean Lesion Reduction(1) P<0.0001 at all time points, favoring Zelsuvmi Median Lesion Reduction TM (2) Zelsuvmi (n= 917) Vehicle (n= 681) Zelsuvmi showed statistically significant benefit vs. vehicle after 2 weeks of therapy and through out the entire 12-week length of the Phase 3 studies Zelsuvmi (n= 917) Vehicle (n= 681)
Zelsuvmi Commercial Overview
12 Activating Key Leverage Points Is Essential to Maximize the Commercial Potential of Zelsuvmi Addressable Patient Population Refills Treated Patients / Initial Prescriptions Price and Revenue 01 02 03 04 Key Leverage Points Up to 6 million new cases each year with an average untreated resolution time of 13 months, during which disease is highly contagious Treated patients respond well to Zelsuvmi and experience dramatic reduction in lesion count and mean time to resolution FDA approved for 12-week treatment regimen, but internal forecasts assume lower WAC of $1,950 per unit. Disclosed peak net revenues of $175M per annum by 2028
13 Commercial Launch Overview Fully built out commercial team: Territory managers supported by Sales Training, Marketing, Commercial Operations & Market Access teams Sales Force of 50 Territory Managers Reaching Highest Molluscum Treaters
14 Zelsuvmi Tactical Launch ApproachDriving Awareness and Adoption Health Care Providers Education Consumer/Patient Education & Awareness National & Regional Conference Presence Live & Virtual Educational Speaker Development KOL Education Now Available Congress Booth & Virtual Booth MD ZELSUVMI Experience Videos CRM Platform: Education & Communication Telehealth ZELSUVMI GO Patient Support Program How to Start & Use Infographic Brochure Now Available Website with Patient-Specific Education Patient CRM Platform Social Media Banner Ads, Native & Paid Search Patient Testimonial Videos Advocacy & Partnerships
15 Strong Uptake of Zelsuvmi in early Launch Phase Zelsuvmi TRx Units Zelsuvmi TRx & HCP Prescribers Week Ending TRx Count TRx Units Prescribers 7/11/2025 7 7 5 7/18/2025 53 56 37 7/25/2025 89 92 67 8/1/2025 109 109 71 8/8/2025 176 179 126 8/15/2025 199 205 150 8/22/2025 234 244 162 Total 867 892 *501 * Total Unique Prescribers Data Source: Symphony Health- Metys Data
NitricilTM Platform & NaV1.7 Pipeline Overview
17 The NitricilTM Platform Macromolecular platform to achieve stable, tunable and druggable delivery of nitric oxide Proprietary platform enabling development of NCEs with sustained delivery of nitric oxide Multiple drug candidates with unique nitric oxide delivery and proven target engagement Proprietary formulations, targeted to each indication, enable tunable dosing Tunable Druggable Stable New Chemical Entity (NCE) Initial Burst Extended Tail Real-Time Nitric Oxide Release
18 Nitricil Platform PipelineAsset Description Asset Description Approx Time to NDA Filing Market Potential SB204 (Acne) Berdazimer topical gel, 3.4% for treatment of acne vulgaris. Phase 3 Clinical stage. 4.5 years $$$ SB414 (AD/Psoriasis) Berdazimer topical cream, dose TBD, for treatment of mild to moderate atopic dermatitis. Phase 1/2 Clinical stage. 7.5 years $$$ (AD) $$ (Psoriasis) SB208 (Tinea Pedis -> Onychomycosis) Low alcohol berdazimer topical gel for treatment of athlete’s foot with label expansion for onychomycosis following initial approval. Phase 2/3 Clinical stage. 5 years (T. Pedis) 6.5 years (Onychomycosis) $$$$$ SB208 (Tinea Pedis + Onychomycosis) Low alcohol berdazimer topical gel for treatment of both athlete’s foot and onychomycosis. Phase 2/3 Clinical stage. 6.5 years $$$$$ SB207 (EGW/PAW) Berdazimer topical gel, 10.3% for treatment of external genital and perianal warts. Same active gel (Tube A) as Zelsuvmi but different hydrogel (Tube B) formulation. Phase 3 clinical stage. 6.5 years $
19 NaV1.7 PipelineProduct/ Indication Asset Description Approximate Time to NDA Filing Market Potential CT2000 Eye Drops Chronic Ocular Pain CC8464 1%, 1.25% and 1.5% ophthalmic solution Phase 1-2a ready 3-4 years $8 billion globally CT2000 Eye Drops Acute Ocular Pain CC8464 1%, 1.25% and 1.5% ophthalmic solution Phase 1-2a ready 2-3 years $400 million globally CT3000 depot Nerve Blocks CC8464 5% and 10% depot injectable Preclinical Stage 5+ years $300-570 million globally CC8464 Oral Erythromelalgia CC8464 melt-granulation capsules 50mg, 100mg, 400mg Phase 1 stage 5+ years $2.4 billion globally CC8464 Oral Small Fibre Neuropathy CC8464 melt-granulation capsules 50mg, 100mg, 400mg Preclinical stage 5+ years $50 million – 100 million CC8464 Oral Acute Pain CC8464 melt-granulation capsules 50mg, 100mg, 400mg Preclinical stage 5+ years $20 billion globally
20 CONFIDENTIAL Key Highlights Strong, Proven Clinical Efficacy In the combined results from the three Phase 3 clinical trials, patients who applied Zelsuvmi for 12 weeks achieved a mean and median reduction in lesion count of 58% and 82%, respectively, compared to 36% and 43% for patients who applied a vehicle control gel Commercially Launched Zelsuvmi was FDA approved In January 2024, and commercially launched in July 2025 as the first and only at-home treatment aimed to revolutionize how MC is treated today for patients ≥ 1 year old Zelsuvmi Differentiated Characteristics Zelsuvmi is a topical gel that uses proprietary nitric oxide release technology and is applied once daily at-home with very good safety profile; opportunity to replace and complement current approved treatment options that are painful and require in-person visits Significant Unmet Need and Sizeable Market Opportunity Large market potential, with up to 6M new cases annually. Treatment of new cases alone has a total addressable market potential of over $20 billion Barriers to Entry Pelthos’ bespoke manufacturing processes require a dedicated line and manufacturing of API under extremely high pressures with stringent safety protocols and procedures; robust set of FDA Orange Book listed patents Financial Opportunity Retained Channel Therapeutics’ pipeline of several NaV1.7 programs following business combination, providing further upside optionality. Currently exploring best monetization strategies. Biopharmaceutical Platform Poised for Growth Pelthos is strategically positioned to execute and integrate complex, synergistic acquisitions, serving as a platform for investors seeking a strong foothold in the specialty biopharmaceutical market
21 Thank You ContactsInvestor Inquiries:Mike MoyerLifeSci Advisors, LLCManaging Directormmoyer@lifesciadvisors.comMedia:KWM CommunicationsKellie Walsh / Rachel Kesslerpelthos@kwmcommunications.com(914) 315-6072