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About Dermata Therapeutics Inc.
Dermata Therapeutics Inc. (NASDAQ: DRMA) is a late-stage biotechnology company headquartered in San Diego, California. Specializing in medical and aesthetic dermatology, Dermata is dedicated to addressing the unmet needs of patients suffering from skin diseases and conditions through innovative pharmaceutical solutions. At the heart of Dermata's offerings is its proprietary Spongilla technology platform, which leverages the unique properties of a naturally sourced freshwater sponge to develop groundbreaking topical treatments.
Core Technology and Product Pipeline
Dermata's Spongilla technology is a multifaceted platform that enables the development of topical treatments with distinct mechanisms of action. The technology utilizes precisely sized and shaped silica spicules derived from processed freshwater sponges to exfoliate the skin, promote collagen production, and create microchannels in the dermis. These microchannels facilitate the penetration of active chemical compounds with antimicrobial and anti-inflammatory properties, making the platform versatile for treating a range of inflammatory skin diseases.
The company's lead product candidate, Xyngari (formerly DMT310), is a once-weekly, topical treatment designed for moderate-to-severe acne, with additional applications for rosacea and psoriasis. Xyngari has shown promising results in clinical trials, achieving statistically significant outcomes for both primary and secondary endpoints. Its unique mechanism of action addresses key challenges in acne treatment, such as patient compliance and tolerability, positioning it as a potential first-line therapy if approved.
Dermata's second product candidate, DMT410, represents an innovative approach to needle-free intradermal delivery of botulinum toxin. This program leverages the Spongilla platform to treat hyperhidrosis and various aesthetic skin conditions. DMT410's potential to replace traditional injection methods could revolutionize botulinum toxin delivery, offering a more patient-friendly alternative.
Market Relevance and Competitive Position
Dermata operates in the dynamic and competitive dermatology market, addressing conditions such as acne, hyperhidrosis, rosacea, and psoriasis, which collectively affect millions of patients worldwide. Acne alone impacts over 30 million individuals annually in the United States, with a significant portion seeking treatment options. By offering a once-weekly topical solution with a favorable safety and efficacy profile, Dermata aims to fill critical gaps in the market.
The company's focus on developing products with unique mechanisms of action differentiates it from competitors. Its ability to address both medical and aesthetic dermatology needs through a single technology platform enhances its potential for broad market adoption. Additionally, Dermata's pipeline benefits from robust intellectual property protection, including patents in the United States, Japan, and Australia, further solidifying its competitive edge.
Clinical Progress and Strategic Collaborations
Dermata is advancing its clinical programs with rigorous scientific validation. Xyngari is currently undergoing Phase 3 trials, with data expected to support a New Drug Application (NDA) filing. Similarly, the DMT410 program has completed Phase 1 proof-of-concept studies and is progressing toward Phase 2a trials in collaboration with Revance Therapeutics. These partnerships underscore Dermata's commitment to leveraging synergies with industry leaders to accelerate product development and commercialization.
Conclusion
Dermata Therapeutics Inc. is at the forefront of dermatological innovation, combining advanced technology, clinical expertise, and strategic partnerships to address significant unmet needs in the treatment of skin diseases. With its proprietary Spongilla platform and promising product pipeline, Dermata is well-positioned to make a meaningful impact in both medical and aesthetic dermatology.
Dermata Therapeutics (NASDAQ: DRMA) announced the Australian Patent Office has accepted its patent application for the DMT410 program for treating hyperhidrosis. This would be Dermata's second patent for DMT410, which uses Spongilla technology to topically deliver botulinum toxin for excessive sweating treatment.
The Company recently entered into a Clinical Trial Collaboration Agreement with Revance to study DMT410 for axillary hyperhidrosis. The upcoming Phase 2a study will explore DMT410's combination of a single XYNGARI™ application followed by a topical application of DAXXIFY®.
Gerry Proehl, Dermata's Chairman, President, and CEO, stated the acceptance further validates DMT410's innovative approach. Beyond hyperhidrosis, the company believes DMT410 holds promise for treating various skin conditions, including acne, rosacea, melasma, acne scars, and other aesthetic concerns.
The patent, entitled "Compositions for the treatment of skin conditions," will be automatically issued three months after acceptance unless opposed by a third party. Dermata also has an issued patent in Japan covering their DMT410 program for hyperhidrosis treatment.
Dermata Therapeutics (NASDAQ:DRMA), a late-stage biotechnology company focused on skin diseases and conditions, has announced an upcoming presentation on BioPub on January 31, 2025, at 12:00PM ET. The interactive online event will feature CEO Gerry Proehl and Chief Development Officer Chris Nardo, Ph.D., who will provide updates on key developments.
The presentation will cover the ongoing XYNGARI™ STAR-1 Phase 3 clinical trial, with topline results expected in March 2025, and discuss their recent collaboration agreement with Revance Therapeutics. Shareholders and investors will have the opportunity to interact with management and ask questions in real-time.
For those unable to attend the live event, an archived webcast will be available on BioPub and Torrey Hills Capital.
Dermata Therapeutics (NASDAQ:DRMA) has closed a private placement offering, raising $2.55 million through the issuance of 2,007,880 shares of common stock and accompanying warrants. The offering was priced at $1.27 per share, at-the-market under Nasdaq rules.
The warrants, also exercisable at $1.27 per share, will become active upon stockholder approval and expire after five years. Company insiders, including the CEO, CFO, and board members, participated in the offering at the same price as other investors. H.C. Wainwright & Co. served as the exclusive placement agent.
The net proceeds, combined with existing cash, are expected to fund operations into Q3 2025. The funds will support research, clinical trials, technology development, potential acquisitions, and working capital. The securities were offered under Section 4(a)(2) of the Securities Act and have not been registered, with the company agreeing to file a resale registration statement.
Dermata Therapeutics (NASDAQ:DRMA) has announced a private placement offering priced at-the-market, raising approximately $2.55 million through the sale of 2,007,880 shares of common stock and accompanying warrants. The transaction is priced at $1.27 per share, with warrants having the same exercise price and a five-year expiration term from stockholder approval.
Company insiders, including the CEO, CFO, and board members, are participating in the offering at the same purchase price as other investors. H.C. Wainwright & Co. is serving as the exclusive placement agent. The closing is expected around January 23, 2025.
The funds will be used for general corporate purposes, including research, pre-clinical studies, clinical trials, technology development, potential acquisitions, and working capital. The securities are being offered under Section 4(a)(2) of the Securities Act and have not been registered, with the company agreeing to file a resale registration statement.
Dermata Therapeutics (NASDAQ:DRMA) and Revance Therapeutics (NASDAQ:RVNC) have announced a clinical trial collaboration to evaluate the topical application of Xyngari™ with Daxxify® for treating primary axillary hyperhidrosis. The companies will initiate a Phase 2a clinical trial involving approximately 48 patients across U.S. sites.
The randomized, double-blind, placebo-controlled trial will assess efficacy, safety, and tolerability over 16 weeks. The study aims to develop the first approved needle-free intradermal delivery of a botulinum toxin product. The trial will measure sweat reduction and evaluate patients at 4 regular intervals.
Xyngari's microscopic spicules create microchannels in the dermis for botulinum toxin delivery, potentially offering an alternative to traditional needle injections. Previous Phase 1 trials of Xyngari with botulinum toxin showed promising efficacy and safety results for both hyperhidrosis and aesthetic skin conditions.
Dermata Therapeutics (NASDAQ:DRMA) announces FDA approval for the proprietary name Xyngari (formerly DMT310) for its Phase 3 acne treatment candidate. The approval is contingent on successful submission and acceptance of a new drug application (NDA). Topline results from the first Phase 3 STAR-1 study are expected in March 2025.
The STAR-1 study is a randomized, double-blind, placebo-controlled trial involving 520 patients with moderate-to-severe facial acne. The study evaluates once-weekly treatment over 12 weeks, with primary endpoints including changes in lesion counts and Investigator Global Assessment scores. If successful, Xyngari could become the first safe, effective, once-weekly topical acne treatment.
Dermata Therapeutics (NASDAQ: DRMA) has received a notice of allowance from the USPTO for a new patent application for its DMT310 product, targeting acne treatment. This marks Dermata's first allowed U.S. patent application for DMT310, which utilizes Spongilla technology for topical acne treatment.
The company has completed enrollment in its DMT310 Phase 3 STAR-1 study and expects to announce topline results in March 2025. The market potential is significant, with over 30 million acne patients seeking treatment annually in the U.S., where topical products serve as first-line therapy.
Dermata Therapeutics (NASDAQ:DRMA) has completed enrollment in its pivotal Phase 3 STAR-1 clinical trial for DMT310, a once-weekly topical treatment for moderate-to-severe acne. The study enrolled 520 patients aged 9 and older across the U.S. and Latin America, with topline results expected in March 2025. This randomized, double-blind, placebo-controlled study is the first of two Phase 3 trials needed to support an NDA filing. The trial will evaluate efficacy through inflammatory and noninflammatory lesion counts and Investigator Global Assessment scores over a 12-week treatment period.
Dermata Therapeutics (NASDAQ:DRMA) reported its Q3 2024 financial results and corporate updates. The company reached 50% enrollment in its DMT310 Phase 3 STAR-1 clinical trial for moderate-to-severe acne, expecting topline results in Q1 2025. Dermata raised $7.8 million in gross proceeds during 2024, with $6.1 million cash on hand as of September 30, 2024. R&D expenses increased to $2.4 million in Q3 2024 from $0.9 million in Q3 2023, while G&A expenses slightly decreased to $0.8 million. The company continues partnership discussions for its DMT410 botulinum toxin delivery program.
Dermata Therapeutics, a late-stage biotechnology company focused on skin diseases and conditions, announced its participation in the 2024 Maxim Healthcare Virtual Summit. The event, presented by Maxim Group , will take place on Tuesday, October 15, 2024.
CEO Gerry Proehl will present at 3:30 PM ET, providing an update on Dermata's Phase 3 acne program followed by a Q&A session. The summit will feature presentations and interactive discussions with CEOs and key management from various healthcare companies, as well as industry panels.
To attend the virtual event, interested parties must sign up for M-Vest membership. Dermata Therapeutics is traded on NASDAQ under the symbols DRMA and DRMAW.
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