Dermata Therapeutics(DRMA) - 2025 Q2 - Quarterly Results

Executive Summary Dermata Therapeutics, a late-stage biotechnology company, announced additional positive data from its XYNGARI™ Phase 3 STAR-1 clinical trial for acne and reported raising $8.8 million in gross proceeds during the first half of 2025 Company Introduction & Key Announcements Dermata Therapeutics, a late-stage biotechnology company, announced additional positive data from its XYNGARI™ Phase 3 STAR-1 clinical trial for acne and reported raising $8.8 million in gross proceeds during the first half of 2025 - Dermata Therapeutics is a late-stage biotechnology company focused on the treatment of medical skin diseases and aesthetic applications[1] - Announced additional positive data from its XYNGARI™ Phase 3 STAR-1 clinical trial, showing statistically significant results for its three co-primary endpoints at weeks 4 and 12[1][2] - Raised $8.8 million in gross proceeds from a private placement and warrant inducement financings during the first half of 2025[1][5] Corporate Highlights & Milestones Dermata reported positive Phase 3 STAR-1 trial data for acne, is planning STAR-2, and secured $8.8 million in financing to extend operations into Q2 2026 Clinical Trial Progress Dermata reported positive topline data from its XYNGARI™ Phase 3 STAR-1 trial for moderate-to-severe acne, meeting all primary endpoints. The company is evaluating next steps for the STAR-2 trial and collaborating with Revance on a Phase 2a study for DMT410 - XYNGARI™ Phase 3 STAR-1 trial for moderate-to-severe acne met all three primary endpoints with highly statistically significant results versus placebo at the end of the study and achieved statistically significant separation from placebo after just 4 weeks[2][5] - The Company initiated additional manufacturing and is evaluating next steps for the XYNGARI™ Phase 3 STAR-2 clinical trial, which would be followed by a 9-month extension study[4] - Collaboration with Revance continues on the final study design and start-up procedures for the Phase 2a clinical study of XYNGARI™ with DAXXIFY® (DMT410) for the topical treatment of axillary hyperhidrosis[6] Financing Activities & Liquidity Outlook Dermata raised $8.8 million in gross proceeds during the first half of 2025, which is expected to fund operations into the second quarter of 2026 - Raised $8.8 million in gross proceeds during the first half of 2025[5] - The funds raised are expected to fund operations into the second quarter of 2026[5][7] Second Quarter 2025 Financial Results Dermata's cash increased to $6.5 million, driven by financing, while operating expenses decreased due to lower R&D, resulting in a reduced net loss Cash Position As of June 30, 2025, Dermata's cash and cash equivalents increased to $6.5 million, up from $3.2 million at December 31, 2024, primarily due to net financing proceeds offsetting operational cash usage Cash and Cash Equivalents | Metric | June 30, 2025 (in thousands USD) | December 31, 2024 (in thousands USD) | Change | | :----- | :------------------------------- | :----------------------------------- | :----- | | Cash and cash equivalents | $6,481 | $3,162 | +$3,319 | - The $3.3 million increase in cash and cash equivalents for the six months ended June 30, 2025, resulted from approximately $7.9 million of net financing proceeds offset by $4.6 million of cash used in operations[7] Operating Expenses Research and development expenses decreased significantly due to the completion of the STAR-1 study, while general and administrative expenses increased due to public company compliance and personnel costs Operating Expenses Summary | Expense Category | Q2 2025 (in thousands USD) | Q2 2024 (in thousands USD) | Change (YoY) | | :--------------- | :------------------------- | :------------------------- | :----------- | | Research and development | $618 | $2,009 | -$1,391 | | General and administrative | $1,155 | $875 | +$280 | | Total operating expenses | $1,773 | $2,884 | -$1,111 | - The $1.4 million decrease in research and development expenses was primarily the result of $1.6 million of decreased clinical expenses from the XYNGARI™ STAR-1 acne study, partially offset by $0.1 million of increased chemistry, manufacturing, and controls (CMC) expenses and $0.1 million of increased personnel costs[8] - The $0.3 million increase in general and administrative expenses resulted from $0.2 million of increased public company compliance costs as well as $0.1 million of increased personnel costs[9] Net Loss and EPS Dermata reported a reduced net loss for Q2 2025 compared to Q2 2024, with a significantly lower net loss per common share due to a substantial increase in weighted average common shares outstanding Net Loss and EPS Summary | Metric | Q2 2025 | Q2 2024 | Change (YoY) | | :----- | :------ | :------ | :----------- | | Net loss (in thousands USD) | $(1,701) | $(2,829) | +$1,128 | | Net loss per common share, basic and diluted | $(1.66) | $(41.82) | +$40.16 | | Weighted average common shares outstanding, basic and diluted | 1,026,506 | 67,654 | +958,852 | About Dermata Therapeutics Dermata Therapeutics is a late-stage biotechnology company leveraging its Spongilla technology platform for lead product candidate XYNGARI™ and second candidate DMT410 Company Profile and Product Candidates Dermata Therapeutics is a late-stage biotechnology company focused on medical skin diseases and aesthetic applications, leveraging its Spongilla technology platform for lead product candidate XYNGARI™ and second candidate DMT410 - Dermata Therapeutics is a late-stage biotechnology company focusing on the treatment of medical skin diseases and aesthetic applications[10] - The Company's lead product candidate, XYNGARI™, developed from its Spongilla technology platform, is a once-weekly, topical product candidate derived from a naturally sourced freshwater sponge, and has achieved positive data in its first Phase 3 clinical trial for acne, also studied for psoriasis and rosacea[10] - The Company's second product candidate, DMT410, uses its XYNGARI™ product candidate as a new method for needle-free intradermal delivery of botulinum toxin for the treatment of multiple aesthetic applications and medical skin diseases like hyperhidrosis, acne, and rosacea[10] Forward-Looking Statements This section contains cautionary statements regarding future events, clinical trials, regulatory approvals, financial performance, and product development, emphasizing that actual results may differ materially from projections due to inherent risks and uncertainties in drug development - Statements in this press release that are not strictly historical in nature are forward-looking statements, based on the Company's current beliefs and expectations, and are subject to known and unknown risks, uncertainties, assumptions, and other factors[11] - Risks include uncertainties inherent in clinical trials (e.g., patient enrollment, completion schedule), timing and ability to initiate clinical trials and generate data, expectations regarding clinical data nature, potential partnership opportunities, sufficiency of cash to fund operations, and the success, cost, and timing of product candidate development activities for XYNGARI™ and DMT410[11] - Actual events or results may differ materially from those projected due to various factors, including risks and uncertainties inherent in drug development, approval, and commercialization, and the fact that past results of clinical trials may not be indicative of future trial results[11] Financial Statements The financial statements present Dermata's balance sheet showing increased assets and equity, and statements of operations reflecting a reduced net loss for Q2 2025 Balance Sheets The balance sheet shows a significant increase in total assets and equity as of June 30, 2025, primarily driven by an increase in cash and cash equivalents, while total liabilities decreased Consolidated Balance Sheets | Metric (in thousands USD) | June 30, 2025 | December 31, 2024 | Change | | :------------------------ | :------------ | :---------------- | :----- | | Cash and cash equivalents | $6,481 | $3,162 | +$3,319 | | Prepaid expenses and other current assets | $160 | $372 | -$212 | | Total assets | $6,641 | $3,534 | +$3,107 | | Accounts payable | $414 | $808 | -$394 | | Accrued liabilities | $612 | $1,165 | -$553 | | Total liabilities | $1,026 | $1,973 | -$947 | | Equity | $5,614 | $1,561 | +$4,053 | | Total liabilities and equity | $6,640 | $3,534 | +$3,106 | Statements of Operations For Q2 2025, Dermata reported a reduced net loss compared to the prior year, driven by lower R&D expenses, despite an increase in G&A. The net loss per share significantly decreased due to a substantial increase in outstanding shares Consolidated Statements of Operations | Metric (in thousands USD) | Quarter Ended June 30, 2025 | Quarter Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :------------------------ | :-------------------------- | :-------------------------- | :----------------------------- | :----------------------------- | | Research and development | $618 | $2,009 | $1,899 | $3,610 | | General and administrative | $1,155 | $875 | $2,214 | $2,477 | | Total operating expenses | $1,773 | $2,884 | $4,113 | $6,087 | | Loss from operations | $(1,773) | $(2,884) | $(4,113) | $(6,087) | | Interest income, net | $72 | $55 | $108 | $124 | | Net loss | $(1,701) | $(2,829) | $(4,005) | $(5,963) | | Net loss per common share, basic and diluted | $(1.66) | $(41.82) | $(5.18) | $(106.44) | | Weighted average common shares outstanding, basic and diluted | 1,026,506 | 67,654 | 772,397 | 56,025 | Stock-based Compensation Expense | Stock-based Compensation Expense (in thousands USD) | Quarter Ended June 30, 2025 | Quarter Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :------------------------------------------------ | :-------------------------- | :-------------------------- | :----------------------------- | :----------------------------- | | Research and development | $8 | $5 | $16 | $242 | | General and administrative | $31 | $15 | $61 | $365 |