Dermata Therapeutics Inc Stock Price, News & Analysis

Dermata Therapeutics (NASDAQ: DRMA) has announced the completion of the last patient visit in their pivotal Phase 3 STAR-1 clinical trial for XYNGARI™, a novel once-weekly topical treatment for moderate-to-severe acne. The trial enrolled 520 patients across the U.S. and Latin America, with topline results expected by end of March 2025.

The STAR-1 study is a randomized (2:1), double-blind, placebo-controlled trial evaluating XYNGARI's efficacy, safety, and tolerability. Primary endpoints include changes in inflammatory and noninflammatory lesion counts and Investigator Global Assessment (IGA) treatment response. The treatment period lasted 12 weeks, with monthly evaluations.

XYNGARI™ targets multiple acne mechanisms, including inflammation reduction and pore unclogging. With over 30 million acne patients seeking treatment annually in the U.S., this represents the first of two pivotal Phase 3 studies required for FDA new drug application submission.

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.