Dermata Therapeutics(DRMA) - 2024 Q4 - Annual Results

Company Overview and Recent Developments Dermata Therapeutics' corporate update covers recent achievements and upcoming milestones, including clinical trial progress and financing activities Introduction and CEO Commentary CEO Gerry Proehl highlighted anticipated XYNGARI™ Phase 3 data and a new collaboration with Revance for DMT410 topical botulinum toxin program - Dermata Therapeutics is a late-stage biotechnology company specializing in medical skin diseases and aesthetic applications[2] - Topline data from the XYNGARI™ Phase 3 STAR-1 trial is anticipated by the end of March 2025[3] - A collaboration agreement with Revance was signed to advance the DMT410 topical botulinum toxin program for hyperhidrosis, acne, and rosacea[3] Corporate Highlights Dermata achieved significant operational milestones in late 2024 and early 2025, including completing enrollment for its lead Phase 3 trial, securing a strategic collaboration, and raising capital to extend its operational runway Key Achievements Dermata completed enrollment for XYNGARI™ Phase 3 STAR-1 trial, initiated a collaboration with Revance for DMT410, and raised $7.8 million in gross proceeds - Enrollment for the XYNGARI™ Phase 3 STAR-1 clinical trial in moderate-to-severe acne was completed in November 2024[7] - A Clinical Trial Collaboration Agreement was signed with Revance in January 2025 for a Phase 2a trial of DMT410 with DAXXIFY® for axillary hyperhidrosis[7] - The company raised $7.8 million in gross proceeds during 2024[7] Anticipated Upcoming Milestones Upcoming milestones include XYNGARI™ Phase 3 STAR-1 topline results by March 2025, initiation of STAR-2, and continued DMT410 Phase 2a preparations, supported by $2.55 million financing - Topline results from the XYNGARI™ Phase 3 STAR-1 clinical trial are expected by the end of March 2025[6][7] - Plans to initiate the XYNGARI™ Phase 3 STAR-2 clinical trial for moderate-to-severe acne, contingent on positive STAR-1 results[7] - Preparation continues for the DMT410 Phase 2a clinical study with Revance for axillary hyperhidrosis[7] - A private placement financing in January 2025 raised $2.55 million in gross proceeds, extending funding into Q3 2025[6] Full Year 2024 Financial Results Dermata Therapeutics' full year 2024 financial results detail cash position, operating expenses, and net loss performance Cash and Liquidity Cash and cash equivalents decreased to $3.2 million by year-end 2024, with current resources expected to fund operations into Q3 2025 Cash and Cash Equivalents (Year-End) | Metric | Dec 31, 2024 | Dec 31, 2023 | Change | | :----------------------- | :----------- | :----------- | :----- | | Cash and cash equivalents | $3.2 million | $7.4 million | -$4.2 million | - The cash decrease was primarily due to $11.1 million used in operations, partially offset by $6.9 million in net financing proceeds[8] - Current cash resources, including $2.55 million from a January 2025 PIPE financing, are projected to fund operations into the third quarter of 2025[8] Operating Expenses Total operating expenses increased significantly in 2024, driven primarily by a substantial rise in research and development costs related to the Phase 3 STAR-1 clinical trial Research and Development Expenses Research and development expenses increased by $4.1 million to $8.2 million in 2024, primarily due to higher clinical trial costs for XYNGARI™ Phase 3 STAR-1 Research and Development Expenses | Metric | 2024 | 2023 | Change | | :----------------------- | :----------- | :----------- | :----- | | R&D Expenses | $8.2 million | $4.1 million | +$4.1 million | - The increase was primarily driven by $4.9 million in clinical trial expenses for the XYNGARI™ Phase 3 STAR-1 clinical trial[9] - This was partially offset by $0.2 million decreased non-clinical expenses and $0.6 million decreased CMC expenses[9] General and Administrative Expenses General and administrative expenses increased to $4.3 million in 2024, primarily due to $0.3 million in increased audit-related fees General and Administrative Expenses | Metric | 2024 | 2023 | Change | | :----------------------- | :----------- | :----------- | :----- | | G&A Expenses | $4.3 million | $4.0 million | +$0.3 million | - The increase was primarily attributable to $0.3 million in increased audit-related fees following a change in auditors in late 2023[10] Net Loss and Per Share Data Net loss increased to $12.29 million in 2024, while net loss per common share decreased to $(8.03) due to increased shares outstanding Net Loss and Per Share Data | Metric | 2024 (in thousands USD) | 2023 (in thousands USD) | Change (in thousands USD) | | :------------------------------------ | :---------------------- | :---------------------- | :------------------------ | | Net loss | $(12,287) | $(7,795) | $(4,492) | | Net loss per common share, basic and diluted | $(8.03) | $(39.99) | $31.96 | | Weighted average common shares outstanding, basic and diluted | 1,529,772 | 194,928 | 1,334,844 | About Dermata Therapeutics Dermata Therapeutics' profile, strategic focus, and product candidates, including XYNGARI™ and DMT410, are detailed Company Profile and Focus Dermata Therapeutics is a late-stage biotechnology company headquartered in San Diego, California, specializing in the development of treatments for medical skin diseases and aesthetic applications - Dermata Therapeutics operates as a late-stage biotechnology company[11] - The company focuses on treating medical skin diseases and aesthetic applications[11] - Dermata is headquartered in San Diego, California[11] Product Candidates and Technology Platform XYNGARI™, a once-weekly topical treatment, is the lead candidate for acne, psoriasis, and rosacea, while DMT410 uses it for needle-free botulinum toxin delivery - XYNGARI™ is the lead product candidate, developed from the Spongilla technology platform[11] - XYNGARI™ is a once-weekly topical product candidate derived from a freshwater sponge, studied for acne, psoriasis, and rosacea[11] - DMT410 is the second product candidate, utilizing XYNGARI™ for needle-free intradermal botulinum toxin delivery for various skin conditions[11] Financial Statements Dermata Therapeutics' financial statements provide detailed balance sheet and statements of operations data for the reported periods Balance Sheets Total assets decreased to $3.53 million by year-end 2024, while total liabilities increased to $1.97 million, and equity significantly declined Balance Sheet Data (in thousands USD) | Metric | Dec 31, 2024 | Dec 31, 2023 | Change | | :-------------------------------- | :----------- | :----------- | :----- | | Cash and cash equivalents | $3,162 | $7,438 | $(4,276) | | Prepaid expenses and other current assets | $372 | $541 | $(169) | | Total assets | $3,534 | $7,979 | $(4,445) | | Accounts payable | $808 | $866 | $(58) | | Accrued liabilities | $1,165 | $757 | $408 | | Total liabilities | $1,973 | $1,623 | $350 | | Equity | $1,561 | $6,356 | $(4,795) | | Total liabilities and equity | $3,534 | $7,979 | $(4,445) | Statements of Operations Net loss for 2024 increased to $12.29 million, driven by higher research and development expenses of $8.20 million and increased G&A costs Statements of Operations Data (in thousands USD, except per share data) | Metric | 2024 | 2023 | Change | | :------------------------------------ | :----------- | :----------- | :----- | | Research and development | $8,204 | $4,070 | $4,134 | | General and administrative | $4,309 | $3,972 | $337 | | Total operating expenses | $12,513 | $8,042 | $4,471 | | Loss from operations | $(12,513) | $(8,042) | $(4,471) | | Interest income | $226 | $247 | $(21) | | Net loss | $(12,287) | $(7,795) | $(4,492) | | Net loss per common share, basic and diluted | $(8.03) | $(39.99) | $31.96 | | Weighted average common shares outstanding, basic and diluted | 1,529,772 | 194,928 | 1,334,844 | Stock-Based Compensation Expense Included | Expense Type | 2024 (in thousands USD) | 2023 (in thousands USD) | | :----------------------- | :---------------------- | :---------------------- | | Research and development | $251 | $194 | | General and administrative | $406 | $328 | Forward-Looking Statements This section outlines the cautionary nature of forward-looking statements, emphasizing inherent risks and uncertainties in projections Disclaimer and Risk Factors Forward-looking statements are subject to known and unknown risks, uncertainties, and assumptions, with actual results potentially differing materially from projections - Statements not strictly historical are forward-looking, based on current beliefs and expectations[12] - Forward-looking statements are subject to known and unknown risks, uncertainties, and factors, including regulatory timing, clinical trials, partnerships, and funding[12] - Actual results may differ materially from projections due to inherent factors in drug development, approval, and commercialization[12] - Dermata undertakes no obligation to revise or update this press release, except as required by law[12]