US Market News
3週前
Dermata Therapeutics Provides Corporate Update and Reports Financial Results for the First Quarter 2026May 13, 2026 4:05 PM
ACCESS Newswire- Dermata announced their Tome Skincare brand for direct-to-consumer ("DTC") skincare products -- Dermata plans to launch its first DTC product, the Tome Foundational Treatment, a once-weekly mask to support skin renewal, in the middle of 2026 -- Raised $2.0 million in net proceeds from it's at-the-market ("ATM") financing facility -SAN DIEGO, CA / ACCESS Newswire / May 13, 2026 / Dermata Therapeutics, Inc. (Nasdaq:DRMA, DRMAW) ("Dermata," or the "Company"), a science-driven leader in dermatologic solutions, today highlighted recent corporate progress and reported financial results for the first quarter ended March 31, 2026."Since announcing our strategic pivot in September 2025, we have made meaningful progress toward becoming a direct-to-consumer commercial skincare company," commented Gerry Proehl, Dermata's Chairman, President, and CEO. "This pivot represents a significant landmark in our mission to deliver safe, effective, and consumer-friendly skincare products. We continue to build on that foundation during the first quarter of 2026 by advancing development of our initial product, refining our brand strategy, and aligning our operations to support commercialization. We are currently finalizing product packaging, putting the finishing touches on the Tome skincare website and getting ready to initiate consumer use studies to provide clinical data to support our upcoming product launches," Mr. Proehl continued. "As we look ahead, we remain focused on executing our planned mid-2026 launch of our once-weekly Foundational Treatment for skin renewal that we believe will bring an in-office-like treatment into the hands of consumers. We believe this product launch will position Dermata to deliver long-term value for both consumers and shareholders," concluded Mr. Proehl.Corporate HighlightsAnnounced its new skincare brand, Tome. In March 2026, Dermata revealed its new skincare brand, Tome, which aims to introduce professional skincare at home. The Tome skincare line will emphasize products Dermata believes can become the essential foundation of any well-rounded skincare routine. The Company plans to add multiple products to the Tome skincare portfolio that utilize time-tested remedies to simplify skincare routines, first starting with a once-weekly Foundational Treatment for skin renewal.Announced the hiring of Kyra Peckaitis as Vice President of Marketing. In March 2026, Ms. Peckaitis joined the Dermata team to lead its new Tome skincare brand. Prior to joining Dermata, Ms. Peckaitis worked at Coterie helping to build its DTC baby care brand. Ms. Peckaitis brings years of experience in DTC marketing and brand building.Raised $2.0 million in net proceeds in Q1 2026. The funds raised during Q1 2026 from the Company's ATM are expected to help fund Dermata's operations into the first quarter of 2027.Anticipated Upcoming MilestonesLaunch first DTC product, Foundational Treatment, in the middle of 2026. The Company is finalizing packaging for the upcoming launch of its Foundational Treatment. The Company believes the Foundational Treatment can be the base of any skincare routine, designed to renew the appearance of the skin and simplify skincare with a once-weekly application. The Company anticipates being ready to launch the Foundational Treatment in the middle of 2026.Continue to prepare for the launch of a second DTC product. The Company is also working on its second DTC product which is expected to launch after its Foundational Treatment.First Quarter 2026 Financial ResultsAs of March 31, 2026, the Company had $6.9 million in cash and cash equivalents, compared to $7.5 million as of December 31, 2025. The $0.6 million decrease in cash and cash equivalents for the quarter ended March 31, 2026, resulted from approximately $2.0 million of ATM financing proceeds which were decreased by approximately $0.1 million from equity financing-related expenses, offset by $2.5 million of cash used in operations. The Company expects its current cash resources to be sufficient to fund operations into the first quarter of 2027.Research and development expenses were $0.4 million for the quarter ended March 31, 2026, compared to $1.3 million for the quarter ended March 31, 2025. The $0.9 million decrease in research and development expenses was the result of $0.7 million of decreased clinical expenses, $0.1 million of decreased chemistry, manufacturing and controls, or CMC, and non-clinical expenses, as well as $0.1 million of decreased personnel expenses.Selling, general and administrative expenses were $1.5 million for the quarter ended March 31, 2026, compared to approximately $1.1 million for the quarter ended March 31, 2025. The increase in selling, general and administrative expenses was primarily attributable to $0.2 million in marketing expenses incurred, $0.2 million of increased audit fees, and $0.1 million of increased legal fees.About Dermata TherapeuticsDermata Therapeutics is a scientific leader in dermatologic solutions that recently announced a strategic pivot from pharmaceutical development to begin focusing on the development and commercialization of direct-to-consumer skincare solutions. The Company is currently developing a first-of-its-kind skin renewal treatment which incorporates Dermata's Bioneedle. The Company plans to launch its initial product in the middle of 2026 with additional innovations planned to follow. Dermata is headquartered in San Diego, California. For more information, or to join our mailing list, please visit http://www.dermatarx.com/.About Tome SkincareTome is Dermata's new skincare line focused on bringing about a new realm of skincare that is powerful, not punishing. Tome in its literal meaning is a large, important, scholarly book. Dermata intends to educate consumers with a brand that tells a skincare story rooted in science and history. Tome will consist of a line of skincare products incorporating its Bioneedle, utilizing Spongilla lacustris, a wild-harvested, freshwater sponge that has evolved over millions of years, as the primary ingredient for consumers that are compelled by history and science to find the most potent products for their skincare routine. Dermata believes its Tome skincare line will simplify existing skincare routines with essential ingredients that deliver results, without harmful extremes. Dermata expects to launch its first product in the middle of 2026 with additional product launches planned to follow. Start your skincare story at www.tomeskincare.com.Forward-Looking StatementsStatements in this press release that are not strictly historical in nature are forward-looking statements. These statements are based on the Company's current beliefs and expectations and new risks may emerge from time to time. Forward-looking statements are subject to known and unknown risks, uncertainties, assumptions and other factors including, but are not limited to, statements related to: Dermata's shift to prioritize DTC skincare products; the anticipated benefits of Dermata's strategic shift to prioritize DTC skincare products, including acceleration of its path to commercialization, reduction of regulatory burdens, and expansion into broader consumer markets; the success, cost, and timing of the launch of its planned or future DTC products, including the Foundational Treatment; the expected timing and success of any planned or future DTC product launches; expectations for the success of the Company's products and their ability to generate revenue for the Company; the Company's expectations with regard to current cash and cash equivalents and the amount of time it will fund operations; and other factors described in the Company's filings with the Securities and Exchange Commission. These forward-looking statements are generally identified by the use of such words as "may," "could," "should," "would," "believe," "anticipate," "forecast," "estimate," "expect," "intend," "plan," "continue," "outlook," "will," "potential" and similar statements of a future or forward-looking nature. These statements are only predictions based on current information and expectations and involve a number of risks and uncertainties. Actual events or results may differ materially from those projected in any of such statements due to various factors, including the risks and uncertainties inherent in product development and commercialization. For a discussion of these and other factors, please refer to Dermata's filings with the Securities and Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. This caution is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. All forward-looking statements are qualified in their entirety by this cautionary statement and Dermata undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof, except as required by law. DERMATA THERAPEUTICS, INC.
Balance SheetsIn thousands USD March 31, 2026 December 31, 2025 (unaudited) Assets Cash and cash equivalents $6,945 $7,522 Prepaid expenses and other current assets 427 342 Inventory 93 - Total assets 7,465 7,864 Liabilities Accounts payable 318 461 Accrued liabilities 734 1,180 Total liabilities 1,052 1,641 Equity 6,413 6,223 Total liabilities and equity $7,465 $7,864 DERMATA THERAPEUTICS, INC.
Statements of Operations
(unaudited) Quarter Ended March 31, In thousands, except share and per share data 2026 2025 Operating expenses Research and development (1) $384 $1,281 Selling, general and administrative (1) 1,542 1,058 Total operating expenses 1,926 2,339 Loss from operations (1,926) (2,339)Interest income 79 36 Net loss $(1,847) $(2,303) Net loss per common share, basic and diluted $(0.48) $(4.47)Weighted average common shares outstanding, basic and diluted 3,858,921 515,465 (1) Includes the following stock-based compensation expense Research and development $14 $8 Selling, general and administrative $29 $29 Investor Contact:Cliff Mastricola
Investor Relations
cmastricola@dermatarx.comSOURCE: Dermata TherapeuticsView the original press release on ACCESS NewswireOriginal: Dermata Therapeutics Provides Corporate Update and Reports Financial Results for the First Quarter 2026
US Market News
2月前
Dermata Therapeutics Provides Corporate Update and Reports Financial Results for the Year Ended 2025March 26, 2026 5:15 PM
ACCESS Newswire- Dermata announced a strategic pivot to develop and commercialize direct-to-consumer ("DTC") skincare products under the brand name Tome -- Dermata plans to launch its first DTC product, our Foundational Treatment, a once-weekly mask to support a skin renewal, in the middle of 2026 -- Raised $4.125 million in gross proceeds from a private placement financing in December 2025, including participation from Dermata's Chief Executive Officer, Chief Financial Officer, and a member of the Company's management -SAN DIEGO, CA / ACCESS Newswire / March 26, 2026 / Dermata Therapeutics, Inc. (Nasdaq:DRMA; DRMAW) ("Dermata," or the "Company"), a science-driven leader in dermatologic solutions, today highlighted recent corporate progress and reported financial results for the year ended December 31, 2025."We are extremely excited as we approach the planned launch of our first DTC product in the middle of 2026, as this will be an important milestone in our company's evolution," said Gerry Proehl, Chairman, President, and CEO of Dermata. "Our team has been extremely busy over the past few months since we announced in September 2025 our strategic pivot to sell direct-to-consumer skincare products. Since the announcement, we have recently revealed our new skincare brand, Tome, hired a new Vice President of Marketing to lead the brand, and are close to finalizing the commercial packaging for our first product," Mr. Proehl continued. "We believe we can leverage our deep knowledge from years of clinical dermatology to deliver DTC skincare products that are efficacious and accessible to consumers. With the cash raised from our recent financings, we believe we are in a good financial position for our planned product launches, with potential revenue to follow," concluded Mr. Proehl.Kyra Peckaitis, Dermata's new Vice President of Marketing, commented, "Having recently joined Dermata, I've been incredibly energized by both the strength of the team and opportunity to create something truly differentiated in the skincare market. We are very excited to announce our first product by Tome, our Foundational Treatment, a once-weekly, foundational step designed to renew the appearance of the skin and improve tone and texture over time. Our Foundational Treatment will incorporate our hero ingredient, Spongillalacustris, a wildly harvested freshwater sponge that we call Bioneedle, to provide consumers with the feel of an aesthetician treatment at home." Ms. Peckaitis continued, "We decided to fast-track the launch of the Foundational Treatment as we see this product reaching a larger market, which can be used as the base product for any skincare routine. We continue to diligently work on our second product, our Clearing Treatment for acne, which we expect to launch for the sizable acne market shortly after launching our Foundational Treatment. In a crowded skincare landscape, we see a real opportunity to stand out by offering solutions that simplify routines while delivering meaningful improvements in how consumer's skin looks and feels, and we believe our Foundational Treatment and Clearing Treatment will do just that."Corporate HighlightsAnnounced strategic pivot to DTC skincare company. In September 2025, Dermata announced that it was making a strategic shift from developing prescription dermatology products to developing and commercializing DTC skincare products. The Company is currently working on branding, packaging, and manufacturing to prepare for the expected launch of its first DTC product, a once-weekly, foundational routine to support skin renewal in the middle of 2026. The Company plans to sell multiple skincare products directly to consumers and directly to aestheticians and dermatologists for in-office treatments.Announced the launch of its new skincare brand, Tome. In March 2026, Dermata revealed its new skincare brand, Tome, which aims to introduce "skintech" at home. The Tome skincare line will emphasize products Dermata believes can become the essential foundation of any well-rounded skincare routine. The Company plans to add multiple products to their Tome skincare portfolio that utilize time-tested remedies to simplify skincare routines.Announced the hiring of Kyra Peckaitis as Vice President of Marketing. In March 2026, Ms. Peckaitis joined the Dermata team to lead the launch of its new Tome skincare brand. Prior to joining Dermata, Ms. Peckaitis worked at Coterie helping to build its DTC baby care brand. Ms. Peckaitis brings years of experience in DTC marketing and brand building.Raised $15.4 million in gross proceeds during 2025 and beginning of 2026. The funds raised during 2025, along with the proceeds from the Company's at-the-market facility in January 2026, are expected to fund its operations into the first quarter of 2027.Announced positive topline data from its XYNGARI Phase 3 STAR-1 clinical trial in moderate-to-severe acne. In March 2025, Dermata announced that its STAR-1 study met all three primary endpoints by producing highly statistically significant results versus placebo at the end of study. In April 2025, Dermata also announced that XYNGARI achieved statistically significant separation from placebo after just 4 weeks, or only four treatments. The STAR-1 study tested Spongillalacustris as a treatment for moderate-to-severe acne, adding to the prior Phase 2b study where XYNGARI achieved statistically significant separation from placebo at all time points. However, the Company has since withdrawn the investigational new drug application for XYNGARI to pursue its new commercial strategy of selling DTC skincare products.Anticipated Upcoming MilestonesLaunch first DTC product, Foundational Treatment, in the middle of 2026. The Company is close to finalizing packaging for the upcoming launch of its Foundational Treatment. The Company believes the Foundational Treatment can be the base of any skincare routine, designed to renew the appearance of the skin and simplify skincare with a once-weekly application. The Company anticipates being ready to launch the Foundational Treatment in the middle of 2026.Launch second DTC product, Clearing Treatment, an over-the-counter ("OTC") acne treatment. The Company is also working on finalizing its second DTC product, its Clearing Treatment, targeting consumers suffering from common forms of acne. This OTC acne treatment will incorporate an FDA approved OTC active ingredient along with the Company's Bioneedle, to provide patients with a targeted treatment for their acne. The Clearing Treatment is expected to launch shortly after the Foundational Treatment.Year Ended 2025 Financial ResultsAs of December 31, 2025, the Company had $7.5 million in cash and cash equivalents, compared to $3.2 million as of December 31, 2024. The $4.3 million increase in cash and cash equivalents for the year ended December 31, 2025, resulted from approximately $12.1 million of net financing proceeds offset by $7.8 million of cash used in operations. The Company expects its current cash resources to be sufficient to fund operations into the first quarter of 2027.Research and development expenses were $2.9 million for the year ended December 31, 2025, compared to $8.2 million for the year ended December 31, 2024. The $5.3 million decrease in research and development expenses was primarily the result of a $5.1 million of decrease in clinical expenses from our STAR-1 acne study, which was completed during the second quarter of 2025. Other research and development activities, including chemistry, manufacturing and controls, or CMC, and non-clinical expenses also decreased by $0.1 million from the prior year as result of the Company's pivot to focus on DTC product sales. The remaining decrease in research and development expenses of $0.1 million was related to personnel expenses.Selling, general and administrative expenses increased by approximately $0.5 million from $4.3 million for the year ended December 31, 2024, to $4.8 million for the year ended December 31, 2025. The increase in selling, general and administrative expenses was primarily attributable to $0.7 million in marketing expenses incurred during the year ended December 31, 2025, offset by approximately $0.2 million in decreased personnel expenses.About Dermata TherapeuticsDermata Therapeutics is a scientific leader in dermatologic solutions that recently announced a strategic pivot from pharmaceutical development to begin focusing on the development and commercialization of direct-to-consumer skincare solutions. The Company is currently developing a first-of-its-kind skin refresh and acne treatments that incorporates Dermata's Bioneedle. The Company plans to launch its initial product in the middle of 2026 with additional innovations planned to follow. Dermata is headquartered in San Diego, California. For more information, or to join our mailing list, please visit http://www.dermatarx.com/.About Tome SkincareTome is Dermata's new skincare line focused on bringing about a new realm of skincare that is powerful, not punishing. Tome in its literal meaning is a large, important, scholarly book. Dermata intends to educate consumers with a brand that tells a skincare story rooted in science and history. Tome will consist of a line of skincare products utilizing Spongilla lacustris, a wildly harvested, freshwater sponge that has evolved over millions of years, for consumers that are compelled by history and science to find the most potent products for their skincare routine. Dermata believes its Tome skincare line will simplify existing skincare routines with essential ingredients that deliver results, without harmful extremes. Dermata expects to launch its first product in the middle of 2026 with additional product launches planned to follow. Start your skincare story at www.tomeskincare.com.Forward-Looking StatementsStatements in this press release that are not strictly historical in nature are forward-looking statements. These statements are based on the Company's current beliefs and expectations and new risks may emerge from time to time. Forward-looking statements are subject to known and unknown risks, uncertainties, assumptions and other factors including, but are not limited to, statements related to: Dermata's shift to prioritize DTC skincare products; the anticipated benefits of Dermata's strategic shift to prioritize DTC skincare products, including acceleration of its path to commercialization, reduction of regulatory burdens, and expansion into broader consumer markets; the success, cost, and timing of the launch of its planned or future DTC products, including Foundational Treatment; the expected timing and success of any planned or future DTC product launches, including Clearing Treatment; expectations for the success of the Company's products and their ability to generate revenue for the Company; the Company's expectations with regard to current cash and cash equivalents and the amount of time it will fund operations; and other factors described in the Company's filings with the Securities and Exchange Commission. These forward-looking statements are generally identified by the use of such words as "may," "could," "should," "would," "believe," "anticipate," "forecast," "estimate," "expect," "intend," "plan," "continue," "outlook," "will," "potential" and similar statements of a future or forward-looking nature. These statements are only predictions based on current information and expectations and involve a number of risks and uncertainties. Actual events or results may differ materially from those projected in any of such statements due to various factors, including the risks and uncertainties inherent in product development and commercialization. For a discussion of these and other factors, please refer to Dermata's filings with the Securities and Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. This caution is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. All forward-looking statements are qualified in their entirety by this cautionary statement and Dermata undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof, except as required by law.DERMATA THERAPEUTICS, INC.
Balance Sheets December 31, 2025 December 31, 2024 In thousands USD Assets Cash and cash equivalents $7,522 $3,162 Prepaid expenses and other current assets 342 372 Total assets 7,864 3,534 Liabilities Accounts payable 461 808 Accrued liabilities 1,180 1,165 Total liabilities 1,641 1,973 Equity 6,223 1,561 Total liabilities and equity $7,864 $3,534 DERMATA THERAPEUTICS, INC.
Statements of Operations Year Ended December 31, 2025 2024 In thousands, except share and per share data Operating expenses Research and development (1) $2,930 $8,204 Selling, general and administrative (1) 4,844 4,309 Total operating expenses 7,774 12,513 Loss from operations (7,774) (12,513)Interest income, net 215 226 Net loss $(7,559) $(12,287) Net loss per common share, basic and diluted $(8.16) $(80.32)Weighted average common shares outstanding, basic and diluted 926,192 152,974 (1) Includes the following stock-based compensation expense Research and development $32 $251 Selling, general and administrative $112 $406 Investors:Cliff Mastricola
Investor Relations
cmastricola@dermatarx.comSOURCE: Dermata TherapeuticsView the original press release on ACCESS NewswireOriginal: Dermata Therapeutics Provides Corporate Update and Reports Financial Results for the Year Ended 2025
US Market News
3月前
Dermata Announces Appointment of Kyra Peckaitis as Vice President, MarketingMarch 10, 2026 8:30 AM
ACCESS Newswire- Kyra Peckaitis will lead the launch of Dermata's recently announced Tome skincare brand -SAN DIEGO, CA / ACCESS Newswire / March 10, 2026 / Dermata Therapeutics, Inc. ("Dermata," or the "Company") (Nasdaq:DRMA)(Nasdaq:DRMAW), a science-driven leader in dermatologic solutions, today announced the appointment of Kyra Peckaitis as Vice President, Marketing. Ms. Peckaitis is a multi-disciplinary brand marketer and will lead Dermata's new brand launch, Tome Skincare. Ms. Peckaitis will oversee the marketing strategy, brand development, and consumer engagement initiatives as Tome gets ready to bring its first commercial products to market in the middle of 2026. Ms. Peckaitis brings years of experience in wellness and personal care consumer brands, with a proven track record of building high-impact brands and driving measurable growth. "We are very excited to have Kyra join our Dermata team as our Vice President, Marketing. As we get ready to launch our first commercial consumer product in the middle of 2026, Kyra will be an invaluable addition in helping build and launch the Tome brand while connecting with consumers," said Gerry Proehl, Dermata's Chief Executive Officer. "Everyone on our team is very excited to have Kyra come on board as she will play a critical role in shaping our go-to-market vision and driving our next phase of growth," concluded Mr. Proehl.Prior to Dermata, Ms. Peckaitis served as Associate Director, Brand Marketing for Coterie, a direct-to-consumer baby care brand. Prior to that, Ms. Peckaitis served on the global brand team for HubSpot and the integrated marketing team at Sweetgreen. Ms. Peckaitis earned her B.S. in Marketing at the University of Maryland, Robert H. Smith School of Business."I'm passionate about building meaningful brand experiences, creating data-driven campaigns, and aligning teams around impactful go-to-market strategies. I'm thrilled to be joining the Dermata team and bringing my experience to launch their first consumer products," said Kyra Peckaitis. "Having experienced the treatment firsthand, I truly believe the positive impact it can have on people's lives and how it will reshape the skincare market. I am confident that we can build a successful brand due to the highly differentiated aspects of Tome. There is nothing quite like it on the market yet," continued Ms. Peckaitis. "My focus will be on combining compelling storytelling, clinical credibility, and deep consumer insights to launch products that truly resonate with skincare enthusiasts. By bringing together science-driven innovation and a modern brand voice, we have an incredible opportunity to create a skincare brand that earns consumer loyalty," concluded Ms. Peckaitis.Ms. Peckaitis began working with Dermata on March 9, 2026 and as part of her joining the Company, she received a non-qualified stock option to purchase 15,000 shares of Dermata's common stock, par value $0.0001 per share, with an exercise price of $1.33 per share, equal to the closing price of Dermata's common stock as reported by Nasdaq on March 9, 2026. One-fourth of the shares vest on the first anniversary of March 9, 2026, with the remaining shares vesting in 36 equal monthly installments thereafter, subject to Ms. Peckaitis' continued service with the Company through each applicable vesting date.The above-described stock option award was granted outside of Dermata's stockholder-approved equity incentive plan. The award was unanimously approved by Dermata's board of directors, as a material inducement to Ms. Peckaitis entering into employment with Dermata in accordance with Nasdaq Listing Rule 5635(c)(4).About Dermata TherapeuticsDermata Therapeutics is a scientific leader in dermatology that recently announced a strategic pivot from pharmaceutical development to begin focusing on the development and distribution of direct-to-consumer skincare solutions. The Company is currently developing first-of-its-kind resurfacing and acne treatment systems that heroes Dermata's Spongilla technology. The Company plans to launch these initial products in the middle of 2026 with additional innovations planned to follow. Dermata is headquartered in San Diego, California. For more information, or to join our mailing list, please visit http://www.dermatarx.com/.About Tome SkincareTome is Dermata's newest skincare line to bring about a new realm of skincare that is powerful, not punishing. Tome in its literal meaning is a large, important, scholarly book. Dermata intends to educate consumers with a brand that tells a story while being rooted in science and history. Tome will consist of a line of skincare products made with Spongilla lacustris, a freshwater sponge that has evolved over millions of years, for consumers that are compelled by science and story to find the most potent products for their skincare routine. Dermata believes its Tome skincare line will amplify existing skincare routines with essential ingredients that deliver exponential results, without harmful extremes. Dermata expects to launch its first products in the middle of 2026 with additional product launches planned to follow. Start your skincare story at www.tomeskincare.com.Forward-Looking StatementsStatements in this press release that are not strictly historical in nature are forward-looking statements. These statements are based on the Company's current beliefs and expectations, and new risks may emerge from time to time. Forward-looking statements are subject to known and unknown risks, uncertainties, assumptions and other factors including, but are not limited to, statements related to: Dermata's shift to commercialize skincare products; the timing of any future announcements; the anticipated benefits of Dermata's strategic shift, including acceleration of its path to commercialization and expansion into broader consumer markets; the expected timing and success of any planned product launches; the potential market acceptance and earning consumer loyalty of any brand or products; and other factors described in the Company's filings with the Securities and Exchange Commission. These forward-looking statements are generally identified by the use of such words as "may," "could," "should," "would," "believe," "anticipate," "forecast," "estimate," "expect," "intend," "plan," "continue," "outlook," "will," "potential" and similar statements of a future or forward-looking nature. These statements are only predictions based on current information and expectations and involve a number of risks and uncertainties. Actual events or results may differ materially from those projected in any of such statements due to various factors, including the risks and uncertainties inherent in product development and commercialization. For a discussion of these and other factors, please refer to Dermata's filings with the Securities and Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. This caution is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. All forward-looking statements are qualified in their entirety by this cautionary statement and Dermata undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof, except as required by law.Dermata Investors:Cliff Mastricola
Investor Relations
cmastricola@dermatarx.comSOURCE: Dermata TherapeuticsView the original press release on ACCESS NewswireOriginal: Dermata Announces Appointment of Kyra Peckaitis as Vice President, Marketing
US Market News
3月前
Dermata Opens a New Chapter with the Release of Tome SkincareMarch 5, 2026 9:00 AM
ACCESS Newswire-The oldest new thing in skincare -- Dermata expects to launch its first product in the middle of 2026 -SAN DIEGO, CA / ACCESS Newswire / March 5, 2026 / Dermata Therapeutics, Inc. (Nasdaq:DRMA)(Nasdaq:DRMAW) ("Dermata" or the "Company"), a science-driven leader in dermatologic solutions, today proudly announces the branding of its latest innovation in skincare: Tome, which aims to introduce "skintech at home". The Company's Tome skincare line will bring intentionally developed skincare that delivers a high level of efficacy by addressing the root causes of skin diseases and conditions. Tome is Studied Skincare™, utilizing timeless ingredients with modern innovations for today's curious skincare consumer. Dermata believes there is immense market opportunity to offer all-natural, multi-action, high-performing skincare treatments directly to consumers for a professional aesthetician feel at home. "With Tome, our mission is to forge a new realm of skincare that is powerful, not punishing," commented Gerry Proehl, Dermata's Chief Executive Officer. "We plan to offer products that are studied by dermatologists but accessible to consumers without the need for a prescription. We intend to prioritize products with natural and safe ingredients that deliver prescription-like results. We believe our products will have heightened potency that never comes at the expense of health and wellbeing of our customers," Mr. Proehl continued. "In a world filled with treatments that complicate routines, over-promise, and underdeliver, Tome exists to be the new foundation of any well-rounded skincare routine. We aren't here to find balance or compromise between existing approaches to skincare, we are melding ancestral wisdom with scientific innovation to create an entirely new ritual for our customers," Mr. Proehl concluded.This announcement marks a significant milestone in the Company's strategic evolution and long-term growth roadmap to become a consumer-facing company specifically tailored to meet the evolving needs of today's skincare consumers. The Tome skincare line will emphasize products Dermata believes can become the essential foundation of any well-rounded skincare routine. In a category full of complex ingredients and daily routines, Tome intends to return to the time-tested remedies with simple but effective weekly routines. While first targeting the launch of an over the counter, once-weekly acne and resurfacing treatment in mid-2026, Dermata believes its Tome product line will become part of an essential foundation for enhancing overall skin quality and beauty.About TomeTome is Dermata's newest skincare line to bring about a new realm of skincare that is powerful, not punishing. Tome in its literal meaning is a large, important, scholarly book, usually telegraphing ancestral innovations. Dermata intends to educate consumers with a brand that tells a story while being rooted in science and history. Tome will consist of a line of skincare products made with Spongilla lacustris, a freshwater sponge that has evolved over millions of years, for consumers that are compelled by science and story to find the most potent products for their skincare routine. Dermata believes its Tome skincare line will amplify existing skincare routines with essential ingredients that deliver exponential results, without harmful extremes. Dermata's first planned product to launch under the Tome brand name is a once weekly treatment, targeting acne, that is an easy addition to any skincare routine. Dermata expects to launch this product in the middle of 2026 with additional product launches planned to follow. Start your skincare story at www.tomeskincare.com.About Dermata TherapeuticsDermata Therapeutics is a scientific leader in dermatology that recently announced a strategic pivot from pharmaceutical development to begin focusing on the development and distribution of direct-to-consumer skincare solutions. The Company is currently developing a once-weekly acne treatment system that utilizes an active ingredient from US Food and Drug Administration over-the-counter monograph in combination with Dermata's Spongilla technology to create a unique treatment option for consumers suffering with acne. The Company plans to launch this initial acne system in the middle of 2026 with additional products planned to follow. Dermata is headquartered in San Diego, California. For more information, or to join our mailing list, please visit http://www.dermatarx.com/.Forward-Looking StatementsStatements in this press release that are not strictly historical in nature are forward-looking statements. These statements are based on the Company's current beliefs and expectations and new risks may emerge from time to time. Forward-looking statements are subject to known and unknown risks, uncertainties, assumptions and other factors including, but are not limited to, statements related to: Dermata's shift to commercialize skincare products; the anticipated benefits of the strategic shift; the timing of any future announcements; the anticipated benefits of Dermata's strategic shift, including acceleration of its path to commercialization, reduction of regulatory burdens, and expansion into broader consumer markets; the expected timing and success of any planned product launches; the potential market acceptance of any products; and other factors described in the Company's filings with the Securities and Exchange Commission. These forward-looking statements are generally identified by the use of such words as "may," "could," "should," "would," "believe," "anticipate," "forecast," "estimate," "expect," "intend," "plan," "continue," "outlook," "will," "potential" and similar statements of a future or forward-looking nature. These statements are only predictions based on current information and expectations and involve a number of risks and uncertainties. Actual events or results may differ materially from those projected in any of such statements due to various factors, including the risks and uncertainties inherent in product development and commercialization. For a discussion of these and other factors, please refer to Dermata's filings with the Securities and Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. This caution is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. All forward-looking statements are qualified in their entirety by this cautionary statement and Dermata undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof, except as required by law.Dermata Investors:Cliff Mastricola
Investor Relations
cmastricola@dermatarx.comSOURCE: Dermata TherapeuticsView the original press release on ACCESS NewswireOriginal: Dermata Opens a New Chapter with the Release of Tome Skincare
subslover
1年前
Dermata’s XYNGARI(TM) Phase 3 Trial Hits Statistically Significant Difference at 4 Weeks
- Dermata previously announced XYNGARI(TM) produced highly statistically significant topline data for all primary endpoints at week 12 in Phase 3 trial -
- Additional data analysis revealed that XYNGARI(TM) separated from placebo after just four once-weekly treatments -
- XYNGARI(TM) could be the first once-weekly topical product candidate for moderate-to-severe acne -
SAN DIEGO, CA / ACCESS Newswire / April 15, 2025 / Dermata Therapeutics, Inc. (Nasdaq:DRMA)(Nasdaq:DRMAW) ("Dermata" or the "Company"), a late-stage biotechnology company focusing on the treatment of medical skin diseases and aesthetic applications, today announced that additional analysis of topline data from its Phase 3 STAR-1 trial showed that XYNGARI™ had a statistically significant difference from placebo on three efficacy endpoints as early as week 4, which occurred after just four treatments with XYNGARI™.
XYNGARI™ Phase 3 STAR-1 Topline Week 4 Efficacy Results
In the intent to treat analysis, Dermata saw statistically significant differences in IGA treatment success, inflammatory lesion count, and non-inflammatory lesion count at week 4 (earliest measured timepoint) when compared to placebo.
Investigator Global Assessment: Patients achieving a 2-point reduction AND score of 0 or 1 ("clear" or "almost clear")
Week 4
XYNGARI™ (n=342)
11.9%
Placebo (n=178)
6.2%
p-value
p < 0.05
Mean change from baseline in inflammatory lesion count
Week 4
XYNGARI™ (n=342)
-11.4
Placebo (n=178)
-8.6
p-value
p < 0.001
Mean change from baseline in non-inflammatory lesion count
Week 4
XYNGARI™ (n=342)
-12.4
Placebo (n=178)
-8.8
p-value
p < 0.001
"We are very excited to see such great separation from placebo as early as week 4, after just four once-weekly treatments, which we believe shows how quickly XYNGARI™ can work for some patients," commented Christopher Nardo, Ph.D., Chief Development Officer of Dermata. "We believe acne patients are looking for a product that can reduce their inflammatory lesions as quickly as possible, which reduces the appearance of acne, and we think XYNGARI's™ early efficacy could be a strong driver of patient compliance. We expect these data, coupled with the fact that XYNGARI™ only needs to be applied once per week, will help differentiate XYNGARI™ from other products currently on the market," concluded Dr. Nardo.
XYNGARI™ Phase 3 STAR-1 Clinical Study Design
The XYNGARI™ Phase 3 STAR-1 clinical study evaluated the efficacy, safety, and tolerability of XYNGARI™ in patients with moderate-to-severe facial acne. The STAR-1 study was a randomized (2:1), double-blind, and placebo-controlled 12 week study which enrolled 520 patients with moderate-to-severe acne, ages 9 years and older in the United States and Latin America. The primary endpoints include the mean change from baseline in inflammatory and noninflammatory lesion counts and the Investigator Global Assessment (IGA) treatment response. IGA is measured on a 5-point scale (0-4), with a treatment response defined as at least a 2-point improvement from baseline and an IGA score of 0 (clear) or 1 (almost clear). Patients were treated once-a-week for 12 weeks with either XYNGARI™ or placebo and were evaluated monthly. The STAR-1 study is the first of two pivotal Phase 3 studies, with the second Phase 3 study to be followed by an extension study. If positive, the results of the Phase 3 program would be used to support the filing of a new drug application with the U.S. Food and Drug Administration.
About XYNGARI™ (formerly DMT310)
XYNGARI™ is a novel, once-weekly, topical product candidate derived from a freshwater sponge being developed for the treatment of multiple skin diseases. XYNGARI™ has multiple mechanisms of action that includemechanical components and chemical compounds to help treat inflammatory skin diseases, like acne. After processing,