All references in this report to “Dermata,” the “Company,” “we,” “us,” or “our” mean Dermata Therapeutics, Inc.
−Removed: and its subsidiaries unless stated otherwise or the context otherwise indicates.
−Removed: We are a late-stage medical dermatology company focused on identifying, developing, and commercializing innovative pharmaceutical product candidates for the treatment of medical and aesthetic skin conditions and diseases we believe represent significant market opportunities.
+Added: unless stated otherwise or the context otherwise indicates.
+Added: We are a late-stage medical dermatology company focused on identifying, developing, and commercializing innovative pharmaceutical product candidates for the treatment of medical skin diseases and aesthetic applications we believe represent significant market opportunities.
Dermatological diseases such as acne vulgaris (or acne), psoriasis vulgaris (or psoriasis), hyperhidrosis, and various aesthetic indications, affect millions of people worldwide each year which may negatively impact their quality of life and emotional well-being.
While there are multiple current treatment options for these indications on the market, we believe that most have significant drawbacks, including underwhelming efficacy, cumbersome application regimens and varying negative side effects, all of which we believe lead to decreased patient compliance.
−Removed: A majority of these indications are first treated with topical therapy, however, many patients frequently switch treatments or discontinue treatment altogether due to patient dissatisfaction.
−Removed: This is primarily due to slow and modest response rates, early onset of negative side effects, daily application schedules and long duration of therapy.
+Added: A majority of these indications are first treated with topical therapies, however, many patients frequently switch treatments or discontinue treatment altogether due to patient dissatisfaction.
+Added: This is primarily due to slow and modest response rates, early tolerability issues, once or twice daily application schedules and long duration of therapy.
Given the limitations with current topical therapies, we believe there is a significant opportunity to address the needs of frustrated patients searching for topical products that satisfy their dermatological and lifestyle needs.
−Removed: Our two product candidates, DMT310 and DMT410, both incorporate our proprietary, multifaceted, Spongilla technology to topically treat a variety of dermatological conditions.
+Added: Our two product candidates, XYNGARI™ (formerly DMT310) and DMT410, both incorporate our proprietary, multifaceted, Spongilla technology to topically treat a variety of dermatological conditions.
Our Spongilla technology is derived from a naturally grown freshwater sponge, Spongilla lacustris or Spongilla , which is processed into a powder that is mixed with a fluidizing agent immediately prior to application to form an easily applicable paste.
Spongilla is a unique freshwater sponge that only grows in commercial quantities in select regions of the world and under specific environmental conditions, all of which give it its distinctive anti-microbial, anti-inflammatory, and mechanical properties.
−Removed: The combination of these environmental conditions, the proprietary harvesting protocols developed with our exclusive supplier, and our post-harvest processing procedures produce a pharmaceutical product candidate that optimizes the mechanical components as well as the chemical components of the sponge to create a product candidate with multiple mechanisms of action for the treatment of inflammatory skin conditions and aesthetic applications.
−Removed: We believe our Spongilla technology platform will enable us to develop and formulate singular and combination products that are able to target the topical delivery of chemical compounds into the dermis for a variety of dermatology indications.
+Added: The combination of these environmental conditions, the proprietary harvesting protocols developed with our exclusive supplier, and our post-harvest processing procedures produce a pharmaceutical product candidate that optimizes the mechanical components as well as the chemical components of the sponge to create a product candidate with multiple mechanisms of action for the treatment of inflammatory skin diseases and aesthetic applications.
+Added: We believe our Spongilla technology platform will enable us to develop XYNGARI TM as either a single, stand-alone agent, or used together with other dermatology products to target the topical delivery of chemical compounds into the dermis for a variety of dermatology indications.
We believe the combination of Spongilla’s mechanical and chemical components (which we believe have demonstrated, in-vitro , anti-microbial and anti-inflammatory properties), add to the versatility of our Spongilla technology platform’s effectiveness as a singular product, in the treatment of a wide variety of medical skin diseases like acne and psoriasis.
−Removed: We also believe the mechanical properties of our Spongilla technology allows for the intradermal delivery of a variety of large molecules, like botulinum toxins, monoclonal antibodies, or dermal fillers, to target treatment sites, through topical application without the need for needles.
−Removed: Our lead product candidate, DMT310, is intended to utilize our Spongilla technology for once weekly treatment of a variety of skin diseases, with our initial focus being the treatment of acne vulgaris, which has a U.S.
−Removed: market size of approximately 50 million patients.
−Removed: We have recently initiated a Phase 3 program of DMT310 in moderate-to-severe acne and began enrolling patients in the first of two identical studies in December of 2023.
−Removed: Both studies will be double blinded, randomized, placebo controlled, and enroll about 550 patients, age 9 years or older across sites in the United States and Latin America.
−Removed: The primary endpoints include absolute reduction in inflammatory and noninflammatory lesions and the improvement in investigators global assessment (IGA) of acne, which are the same endpoints used in our Phase 2b study of DMT310 for moderate-to-severe acne.
−Removed: Patients will be treated once a week for 12 weeks with either DMT310 or placebo and will be evaluated monthly.
−Removed: We expect to have top-line results from the first Phase 3 study in the first quarter of 2025.
−Removed: Previously DMT310 has shown its ability to treat the multiple causes of acne in a Phase 2b study where we initially saw a 45% reduction in inflammatory lesions after four treatments, with DMT310 achieving statistically significant improvements at all time points for all three primary endpoints throughout the study (reduction in inflammatory lesions, reduction in non-inflammatory lesions, and improvement in IGA).
−Removed: In addition, based on the multiple mechanisms of action and anti-inflammatory effect seen with the DMT310 acne trial, we completed a Phase 1b proof of concept, or POC, trial in psoriasis where we saw encouraging results warranting further investigation.
−Removed: DMT310 consists of two grams of powder processed from the naturally grown freshwater sponge, Spongilla lacustris.
−Removed: The patient mixes the powder with a fluidizing agent (hydrogen peroxide) immediately prior to application by the patient to form an easy-to-apply paste.
−Removed: The paste is applied similar to a mud mask and is left on the skin for approximately ten to fifteen minutes, after which time it is washed off with water.
−Removed: Due to the unique combination of DMT310’s mechanical components and chemical components, and based on our Phase 2 acne data, we believe patients will only need to apply DMT310 once-weekly to produce a desired treatment effect.
+Added: We also believe the mechanical properties of our Spongilla technology allows for the intradermal delivery of a variety of large molecules, like botulinum toxins, monoclonal antibodies, or dermal fillers, to targeted treatment sites, through topical application without the need for needles.
+Added: Our lead product candidate, XYNGARI™, is intended to utilize our Spongilla technology for the once weekly treatment of a variety of skin diseases, with our initial focus being the treatment of acne, which has a U.S.
+Added: market size of approximately 30 million patients seeking treatment.
+Added: In November 2024, we completed patient enrollment in the first of two planned Phase 3 clinical trials of XYNGARI™ in moderate-to-severe acne.
+Added: We expect to receive top-line results from the first Phase 3 trial in March 2025.
+Added: Each Phase 3 study will be double-blind, randomized, placebo controlled, and enroll over 500 patients with moderate to severe acne, age 9 years or older across sites in the United States and Latin America.
+Added: The primary endpoints include absolute reduction in inflammatory and noninflammatory lesions and the improvement in investigators global assessment (IGA) of acne.
+Added: Patients will be treated once a week for 12 weeks with either XYNGARI™ or placebo and will be evaluated monthly.
+Added: As requested by the FDA, the second Phase 3 study will be followed by an extension study to follow patients for a 12-month total treatment period.
+Added: Previously XYNGARI™ has shown its ability to treat the multiple causes of acne in a Phase 2b study where we initially saw a 45% reduction in inflammatory lesions after four treatments, with XYNGARI™ achieving statistically significant improvements at all time points for all three primary endpoints throughout the study (reduction in inflammatory lesions, reduction in non-inflammatory lesions, and improvement in IGA).
+Added: In addition, based on the multiple mechanisms of action and anti-inflammatory effect seen with the XYNGARI™ acne trial, we completed a Phase 1b proof of concept, or POC, trial in psoriasis where we saw encouraging results warranting further investigation upon our receipt of adequate funding.
+Added: XYNGARI™ consists of two grams of powder processed from the naturally grown freshwater sponge, Spongilla lacustris.
+Added: The patient mixes the powder with a fluidizing agent (3% hydrogen peroxide) immediately prior to application to form an easy-to-apply paste.
+Added: The paste is applied like a mud mask and is left on the skin for approximately ten to fifteen minutes, after which time it is washed off with water.
+Added: Due to the unique combination of XYNGARI™’s mechanical components and chemical components, and based on our Phase 2 acne data, we believe patients will only need to apply XYNGARI™ once weekly to produce the desired treatment effect.
The mechanical components of the Spongilla powder consist of many microscopic siliceous, needle-like spicules that, when massaged into the skin, penetrate the stratum corneum (the skin’s outermost protective layer) and create microchannels into the dermis where pro-inflammatory cytokines and bacteria reside.
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acnes , which grow in an anaerobic (without oxygen) environment ( C.
−Removed: acnes is the bacteria that cause inflammatory lesions in acne patients).
−Removed: The spicules also cause rejuvenation of the top layer of dead skin, thereby increasing collagen production.
−Removed: Additionally, we believe the newly created microchannels provide a conduit for DMT310’s naturally occurring chemical compounds to be delivered to the dermis and pilosebaceous glands, helping to kill the C.
−Removed: acnes and fight inflammation .
−Removed: In addition to these anti-microbial compounds, DMT310 also appears to have anti-inflammatory chemical compounds, as demonstrated in in vitro experiments, that inhibit inflammation through the reduction of C.acnes stimulated IL-8 production and by inhibiting IL-17A and IL-17F expression in human cell lines.
−Removed: Also, during in vitro studies of DMT310’s organic compounds, we observed the inhibition of the lipogenesis of sebocytes, which may translate to a reduction in sebum (an oily and waxy substance produced by the human body’s sebaceous glands) production and the oiliness of the skin in patients, which was observed by a number of clinical investigators in our Phase 2 acne studies.
+Added: acnes are the bacteria that cause inflammatory lesions in acne patients).
+Added: The spicules also cause turnover of the top layer of dead skin, thereby increasing collagen production resulting in skin rejuvenation.
+Added: Additionally, we believe the newly created microchannels provide a conduit for XYNGARI™’s naturally occurring chemical compounds to be delivered to the dermis and pilosebaceous glands, helping to kill the C.
+Added: acnes and reduce inflammation .
+Added: In addition to anti-microbial compounds, XYNGARI™ also appears to have anti-inflammatory chemical compounds, as demonstrated during in vitro experiments, that inhibit inflammation through the reduction of C.acnes stimulated IL-8 production and by inhibiting IL-17A and IL-17F expression in human cell lines.
+Added: Also, during in vitro studies of XYNGARI™’s organic compounds, we observed the inhibition of the lipogenesis of sebocytes, which may translate to a reduction in sebum (an oily and waxy substance produced by the human body’s sebaceous glands) production and the oiliness of the skin in patients, which was observed by a number of clinical investigators in our Phase 2 acne studies.
We believe the combination of these biological and mechanical effects could be important factors in treating multiple inflammatory skin diseases, as seen in our clinical trials.
−Removed: Our second product candidate utilizing our Spongilla technology is DMT410, our combination treatment.
+Added: Our second product candidate utilizing our Spongilla technology is DMT410.
DMT410 is intended to consist of one treatment of our proprietary sponge powder followed by one topical application of botulinum toxin for delivery into the dermis.
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However, we believe DMT410’s ability to topically deliver botulinum toxin into the dermis could have similar levels of efficacy to existing delivery techniques, with fewer tolerability issues, and a quicker application time, possibly replacing the need for intradermal injections.
−Removed: We first tested DMT410 in a Phase 1 POC trial of axillary hyperhidrosis patients, which saw 80% of patients achieve a reduction in gravimetric sweat production greater than 50% four weeks after a single treatment.
+Added: We first tested DMT410 in a Phase 1 POC trial in primary axillary hyperhidrosis patients where we observed 80% of patients achieving a reduction in gravimetric sweat production greater than 50% four weeks after a single treatment.
With almost 40% of the hyperhidrosis market currently being treated with intradermal injections of botulinum toxin, we believe there could be significant opportunity for DMT410 to break into this market and replace intradermal injections of botulinum toxin.
Based on DMT410’s ability to effectively deliver botulinum toxin to the dermis as observed in the Phase 1 axillary hyperhidrosis trial, we also conducted a Phase 1 POC trial of DMT410 for the treatment of multiple aesthetic skin conditions, including reduction of pore size, sebum production, and fine lines, among others.
−Removed: In November 2021, we announced top-line results from this trial, where we saw promising data that we believe warrants further investigation of DMT410.
−Removed: We are currently in the process of discussing partnering opportunities with botulinum toxin companies to move the DMT410 program into Phase 2 studies.
−Removed: Application of DMT310
+Added: In November 2021, we announced top-line results from this trial, where we saw promising data that we believed warranted further investigation of DMT410.
+Added: On January 17, 2025, we entered into a Clinical Trial Collaboration Agreement (the “Clinical Trial Agreement”) with Revance Therapeutics, Inc., who recently merged with Crown Laboratories, (“Revance”), pursuant to which we in collaboration with Revance intend to conduct a multi-center Phase 2 clinical trial to evaluate the topical application of XYNGARI™, with DAXXIFY® (daxibotulinumtoxinA-lanm), Revance’s botulinum toxin type A, for the treatment of axillary hyperhidrosis (the “Trial”).
+Added: Application of XYNGARI™
The Spongilla is processed into a fine powder and packaged into 2g pouches with a 6mL bottle of 3% H 2 O 2 (hydrogen peroxide).
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after 10-15 minutes the product is easily removed with water.
−Removed: We believe that the current medical and aesthetic dermatology landscape lacks innovative treatment options, mainly seeing the introduction of reformulations or combinations of old molecules.
+Added: We believe that the current medical and aesthetic dermatology landscape lacks innovative treatment options, with new treatments predominantly being the introduction of reformulations or combinations of old molecules.
We believe this lack of innovation provides an ideal opportunity for us to change how patients treat their skin conditions.
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Our Clinical Development Pipeline and Product Candidates
−Removed: Our clinical development pipeline currently consists of DMT310 and DMT410, each in development for multiple skin diseases and conditions.
+Added: Our clinical development pipeline currently consists of XYNGARI™ and DMT410, each in development for multiple skin diseases and conditions.
In the accompanying section we will describe each product candidate, its benefits, and our market strategy for each product candidate.
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Moderate-to-Severe Acne.
−Removed: In December 2023, we began enrolling patients in the first of two Phase 3 clinical studies of DMT310 for the treatment of moderate-to-severe acne.
−Removed: Each study will be double blind, randomized, placebo controlled, and enroll about 550 patients, age 9 years or older across sites in the United States and Latin America.
−Removed: with the primary endpoints being the absolute reduction in inflammatory and noninflammatory lesions and the improvement in investigators global assessment (IGA) of acne as were used in our DMT310 Phase 2b acne study.
−Removed: Patients will be treated once a week for 12 weeks with either DMT310 or placebo and will be evaluated monthly.
−Removed: The first Phase 3 study is expected to have top-line results in the first quarter of 2025 .
−Removed: In June 2020, we completed a randomized, double-blind, multicenter, placebo-controlled Phase 2b clinical trial of DMT310 for the once weekly treatment of moderate-to-severe acne.
−Removed: DMT310 showed statistically significant improvement versus placebo for all three endpoints (inflammatory lesion counts, non-inflammatory lesion counts, and IGA), after only four topical treatments and continued to statistically separate from placebo through the end of study at week 12.
−Removed: We believe these results from once weekly applications may favorably position DMT310 as a first-in-class product in the market for the treatment of moderate-to-severe acne.
+Added: In December 2023, we began enrolling patients in the first of two Phase 3 clinical studies of XYNGARI™ for the treatment of moderate-to-severe acne, entitled the Spongilla Treatment of Acne Research (STAR-1) study.
+Added: Each study will be double blind, randomized, placebo controlled, and enroll over 500 patients, age 9 years or older across sites in the United States and Latin America.
+Added: The primary endpoints will include the absolute reduction in inflammatory and noninflammatory lesions and the improvement in investigators global assessment (IGA) of acne as were used in our XYNGARI™ Phase 2b acne study.
+Added: Patients will be treated once a week for 12 weeks with either XYNGARI™ or placebo and will be evaluated monthly.
+Added: In November 2024, we completed enrollment of the STAR-1 study with a total of 520 patients.
+Added: The STAR-1 Phase 3 study is expected to have top-line results in the March of 2025 .
+Added: Previously, we completed a randomized, double-blind, multicenter, placebo-controlled Phase 2b clinical trial of XYNGARI™ for the once weekly treatment of moderate-to-severe acne.
+Added: XYNGARI™ showed statistically significant improvement versus placebo for all three endpoints (inflammatory lesion counts, non-inflammatory lesion counts, and IGA), after only four topical treatments and continued to statistically separate from placebo through the end of study at week 12.
+Added: We believe these results from once weekly applications may favorably position XYNGARI™ as a first-in-class product in the market for the treatment of moderate-to-severe acne, if approved.
Mild-to-Moderate Psoriasis.
−Removed: In October 2021, we completed a Phase 1b POC trial of DMT310 for the once weekly treatment of mild-to-moderate psoriasis.
+Added: In October 2021, we completed a Phase 1b POC trial of XYNGARI™ for the once weekly treatment of mild-to-moderate psoriasis.
Plaque psoriasis is a chronic, inflammatory skin disease that comprises approximately 80% of the psoriasis market as of 2019, according to Fortune Business Insights Market Research Report, a majority of patients have mild-to-moderate disease which makes them less likely to receive an approved biologic treatment, that are only indicated for patients with moderate to severe disease, as a first line therapy.
Due to the large population of patients who suffer from mild-to-moderate psoriasis, and lack of effective topical therapies for more mild disease, we believe there is a large unmet need for an effective topical product with limited side effects.
−Removed: Based on the data in our Phase 1b POC trial, the in-vitro data of DMT310’s reduction of IL-17A and IL-17F, and the anti-inflammatory effects we observed in its Phase 2b trial for acne, we believe DMT310 may be used as a first-line therapy for patients suffering from mild-to-moderate psoriasis who are not candidates for biologic treatments.
−Removed: In October 2021, we announced top-line results from our Phase 1b POC trial of DMT310 for the treatment of 30 mild-to-moderate patients with psoriatic lesions covering between 2% to 30% of their body surface area.
−Removed: Patients were treated with DMT310 once a week for 12 weeks.
+Added: Based on the data in our Phase 1b POC trial, the in-vitro data of XYNGARI’s™ reduction of IL-17A and IL-17F, and the anti-inflammatory effects we observed in its Phase 2b trial for acne, we believe XYNGARI™ may be used as a first-line therapy for patients suffering from mild-to-moderate psoriasis who are not candidates for biologic treatments.
+Added: In October 2021, we announced top-line results from our Phase 1b POC trial of XYNGARI™ for the treatment of 30 mild-to-moderate patients with psoriatic lesions covering between 2% to 30% of their body surface area.
+Added: Patients were treated with XYNGARI™ once a week for 12 weeks.
Based on the efficacy, safety and tolerability profile observed in the POC trial, we initiated additional work to better inform our clinical trial design prior to moving into a larger Phase 2, placebo-controlled, clinical trial.
−Removed: We plan to continue development of DMT310 for the treatment of psoriasis upon the acquisition of additional financial resources to support such development.
−Removed: Moderate-to-Severe Rosacea.
−Removed: On December 5, 2022, we announced topline results from our Phase 2 trial of once-weekly topical application of DMT310 for the treatment of moderate-to-severe rosacea.
−Removed: The data was supportive of DMT310 as a treatment for inflammatory skin diseases, but the rosacea study did not meet its primary endpoints.
−Removed: While some patients did achieve a meaningful change in their rosacea, with 36% of DMT310 patients meeting the criteria for a responder on the Investigator Global Assessment (IGA) score, DMT310 was not able to statistically separate from placebo with 23% of placebo patients meeting the criteria as a responder at Week 12.
−Removed: A treatment responder is defined as an IGA grade of ‘clear’ or ‘almost clear’ and at least a 2-grade improvement from baseline.
−Removed: Based on the foregoing, we have decided not to devote any further financial resources to the development of this indication for DMT310 at this time.
−Removed: We are developing the second product candidate from our Spongilla platform, DMT410, for the topical treatment of skin diseases and aesthetic conditions typically treated with multiple injections of botulinum toxin.
−Removed: Currently, botulinum toxin must be injected multiple times to successfully deliver enough botulinum toxin to the desired treatment area.
+Added: We plan to continue development of XYNGARI™ for the treatment of psoriasis upon the acquisition of additional financial resources to support such development.
+Added: We are developing the second product candidate from our Spongilla platform, DMT410, for the topical treatment of skin diseases and aesthetic conditions typically treated with multiple intradermal injections of botulinum toxin.
+Added: Currently, botulinum toxin must be intradermally injected multiple times to successfully deliver enough botulinum toxin to produce the desired effect in the desired treatment area.
While injections are effective for many different diseases and aesthetic conditions, they limit botulinum toxin’s use for additional conditions where injections, especially intradermal injections, are difficult, painful, or otherwise not viable.
−Removed: DMT410’s combination treatment regimen uses one application of our unique Spongilla powder followed by one topical application of botulinum toxin.
+Added: Some of these conditions include hyperhidrosis, acne, acne scars, and various aesthetic indications, of which DMT410 could be a viable treatment option.
+Added: DMT410’s treatment regimen uses one application of our XYNGARI™ followed by one topical application of botulinum toxin.
The Spongilla powder is mixed with a fluidizing agent and is massaged into a patient’s treatment area by the treating physician to enhance spicule penetration to create microchannels into the dermis.
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The physician then expresses botulinum toxin from a syringe in precise amounts and onto the patient’s skin.
−Removed: The botulinum toxin is then massaged into the treatment area to take advantage of the microchannels created by Spongilla’s spicules, which allows the botulinum toxin to penetrate the stratum corneum and enter the dermis.
+Added: The botulinum toxin is then massaged into the treatment area to take advantage of the microchannels created by the Spongilla’s spicules, which allows the botulinum toxin to penetrate the stratum corneum and enter the dermis.
We believe this treatment application will enable the topical delivery of botulinum toxin into the dermis for the treatment of a variety of medical diseases, including for the treatment of hyperhidrosis, acne, and acne scars, as well as improving the skin’s luminosity, brightness, and reducing pore size and count, fine lines, and sebum production.
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Four weeks after one treatment with DMT410, 80% of patients experienced a decrease in gravimetric sweat production greater than 50%, 85% of patients recorded gravimetric sweat production of less than 50mg, and patients had an average decrease in gravimetric sweat production of 75% from baseline.
−Removed: We believe these results support that DMT410 may aid in the topical delivery of botulinum toxin into the dermis for a treatment effect similar to multiple intradermal injections of botulinum toxin.
+Added: We believe these results demonstrate that DMT410 may aid in the topical delivery of botulinum toxin into the dermis for a treatment effect similar to multiple (estimated 15-20) intradermal injections of botulinum toxin.
With DMT410, we believe botulinum toxin may be applied topically to penetrate the skin into the dermis without the need for multiple injections.
−Removed: We also completed an open-label, ten (10) patient, Phase 1b POC trial of DMT410 for the treatment of multiple aesthetic skin conditions (pore size, Global Aesthetic Improvement, brightness, luminosity, sebum production, fine lines under the eye, glabellar lines, forehead lines, and lateral canthal lines) and announced topline results in November 2021.
+Added: We also completed an open-label, ten (10) patient, Phase 1b POC trial of DMT410 for the treatment of multiple aesthetic skin conditions (pore size, Global Aesthetic Improvement, brightness, luminosity, sebum production, fine lines, glabellar lines, forehead lines, and lateral canthal lines) and announced topline results in November 2021.
In our Phase 1b POC trial of DMT410, patients received one treatment of DMT410 and were evaluated every four weeks for a total duration of 16 weeks to determine DMT410’s safety and tolerability profile, effectiveness, and its duration of treatment effect.
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We believe these results, combined with our results in hyperhidrosis, clearly demonstrate how DMT410’s combination regimen could greatly expand the potential indications for botulinum toxins for aesthetic skin conditions, as well as other dermatologic skin diseases such as hyperhidrosis, acne, or acne scars.
−Removed: There can be no assurance that DMT310 or DMT410 will receive FDA approval for any of the foregoing indications.
+Added: In January 2025, we entered into the Clinical Trial Agreement with Revance pursuant to which we in collaboration with Revance intend to conduct a multi-center Phase 2 clinical trial to evaluate the topical application of XYNGARI™, with DAXXIFY® (daxibotulinumtoxinA-lanm), Revance’s botulinum toxin type A, for the treatment of primary axillary hyperhidrosis.
+Added: Under the Clinical Trial Agreement, we intend to sponsor, conduct, and fund a Phase 2a clinical trial to evaluate the safety, tolerability and preliminary efficacy of XYNGARI™ and DAXXIFY® versus XYNGARI™ and placebo in patients with moderate-to-severe axillary hyperhidrosis for 16 weeks.
+Added: The axillary hyperhidrosis trial is anticipated to be randomized (1:1:1:1), double-blind, dose-ranging, placebo-controlled, and intends to enroll approximately 48 patients across sites in the United States.
+Added: The endpoints are anticipated to be (i) the percent of patients with greater than 50% reduction in gravimetrically measured sweat production from baseline, (ii) the percent of patients with gravimetric sweat production less than 50mg, and (iii) the mean absolute change from baseline in gravimetrically measured sweat production.
+Added: Patients are anticipated to be evaluated at four regular intervals.
+Added: Under the Clinical Trial Agreement, Dermata and Revance will form a joint development committee to facilitate communications between the parties related to the Trial.
+Added: There can be no assurance that XYNGARI™ or DMT410 will receive FDA approval for any of the foregoing indications.
We plan on in-licensing, developing and commercializing differentiated medical and aesthetic dermatology product candidates for the treatment of various skin diseases and conditions, which we believe have significant unmet needs in the market.
The key components of this strategy are as follows:
−Removed: Complete development and regulatory approval of DMT310 for acne .
−Removed: We initiated the first of two Phase 3 clinical studies of DMT310 for the treatment of acne in December 2023.
−Removed: We expect to receive top-line results from the first study in the first quarter of 2025.
−Removed: In 2025, we plan on initiating the second DMT310 Phase 3 clinical study followed by a long-term extension study.
+Added: Complete development and regulatory approval of XYNGARI™ for acne .
+Added: We initiated the first of two STAR-1 Phase 3 clinical studies of XYNGARI™ for the treatment of moderate-to-severe acne in December 2023 and completed enrollment of the STAR-1 Phase 3 trial in November 2024.
+Added: We expect to receive top-line results from the STAR-1 trial in March of 2025.
+Added: If the results of the STAR-1 trial are positive, in 2025, we plan on initiating the second XYNGARI™ Phase 3 clinical trial entitled STAR-2, followed by a long-term extension study as requested by FDA.
We also plan to initiate the FDA required dermal carcinogenicity studies in rats and the repeat dose dermal toxicity study in minipigs.
−Removed: Assuming positive results from the Phase 3 program, we plan on submitting a New Drug Application to FDA approximately 6 months after completion of the trials.
−Removed: Explore mutually beneficial partnership opportunities for our DMT410 program in hyperhidrosis and aesthetic skin conditions.
−Removed: We have received top-line results from two Phase 1b POC trials of DMT410 in both axillary hyperhidrosis and for the treatment of multiple aesthetic skin conditions using our Spongilla technology for the topical application of OnabotulinumtoxinA (brand name BOTOX®).
−Removed: We believe these trials provide further evidence of the ability for DMT410 to topically deliver any botulinum toxin into the dermis for skin conditions and diseases.
−Removed: Based on the results of DMT410 in hyperhidrosis and aesthetics, we are currently discussing partnership opportunities with multiple botulinum toxin companies to further develop DMT410 for the topical treatment of skin diseases and aesthetic skin conditions.
−Removed: Complete a Phase 2 trial of DMT310 for the treatment of psoriasis.
+Added: Assuming positive results from the Phase 3 program, we plan on submitting a New Drug Application (NDA) to FDA approximately 6 months after completion of the studies.
+Added: Explore mutually beneficial partnership opportunities for our XYNGARI™ program.
+Added: If we receive positive results from our XYNGARI™ STAR-1 Phase 3 trial, we will look for a partner that may be interested in helping Dermata complete the development of the XYNGARI™ Phase 3 program, with the ultimate goal to commercialize XYNGARI™.
+Added: If we are unable to find a mutually beneficial partner for the XYNGARI™ program, then we plan to continue the development program and prepare to file an NDA with FDA.
+Added: Expand on the mutually beneficial partnership with Revance for our DMT410 program in hyperhidrosis and aesthetic skin conditions.
+Added: In January 2025, we entered into a Clinical Trial Collaboration Agreement with Revance to explore the use of XYNGARI™ with DAXXIFY® for the topical treatment of axillary hyperhidrosis in a Phase 2a clinical trial.
+Added: If successful, we will look to expand on the partnership with Revance in other indications.
+Added: Complete a Phase 2 trial of XYNGARI™ for the treatment of psoriasis.
In October 2021, we announced top-line results of our Phase 1b POC trial in patients with mild-to-moderate psoriasis.
−Removed: We believe the results of this POC study warrant further development of DMT310 for the treatment of psoriasis.
−Removed: If successfully developed and commercialized, we believe DMT310 would be the first once weekly topical product available to treat psoriasis.
−Removed: The DMT310 program for psoriasis is currently on hold with further advancement subject to obtaining additional financing and/or a strategic partner.
+Added: We believe the results of this POC study warrant further development of XYNGARI™ for the treatment of psoriasis.
+Added: If successfully developed and commercialized, we believe XYNGARI™ would be the first once weekly topical product available to treat psoriasis.
+Added: The XYNGARI™ program for psoriasis is currently on hold with further advancement subject to obtaining additional financing and/or a strategic partner.
Acquire or in-license additional dermatology programs to our portfolio that complement our current product candidates .
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We intend to focus on early to mid-stage development product candidates to generate clinical data and potentially move to later stages of development and ultimately on to commercialization.
−Removed: Maximize the value of our portfolio by commercializing our product candidates in territories where we can do so effectively and partner for other territories to help us reach new markets.
−Removed: We plan to maximize the territories where our product candidates could be sold by partnering with established companies in new territories outside of the U.S.
−Removed: market for development and potential commercialization, if possible.
+Added: Maximize the value of our portfolio by partnering with companies who can assist with commercializing our product candidates in territories throughout the world.
+Added: We plan to explore partnerships with companies throughout the world who have established commercial organizations focused on dermatologists.
Further strengthen our intellectual property portfolio, path to new chemical entity, or NCE, exclusivity, raw material supply and advance our regulatory filings.
−Removed: We plan to continue to strengthen our IP portfolio for DMT310 and DMT410, seek NCE exclusivity for DMT310, maintain our exclusive supply agreement for our raw material requirements, and continue to protect our proprietary information.
+Added: We plan to continue to strengthen our IP portfolio for XYNGARI™ and DMT410, seek NCE exclusivity for XYNGARI™, maintain our exclusive supply agreement for our raw material requirements, and continue to protect our proprietary information.
We believe these activities will be our primary competitive advantages if our product candidates receive regulatory approval.
The dates reflected in the foregoing are estimates only, and there can be no assurances that the events included will be completed on the anticipated timeline presented, or at all.
−Removed: Further, there can be no assurance that we will be successful in the development of DMT310 or DMT410, or any other product candidate we may develop in the future, or that DMT310 or DMT410, or any other product candidate we may develop in the future, will receive FDA approval for any indication.
+Added: Further, there can be no assurance that we will be successful in the development of XYNGARI™ or DMT410, or any other product candidate we may develop in the future, or that XYNGARI™ or DMT410, or any other product candidate we may develop in the future, will receive FDA approval for any indication.
Dermatology Market Overview
−Removed: We are currently focused on the medical and aesthetic dermatology markets, which include multiple common and undertreated skin diseases and conditions such as acne, psoriasis, hyperhidrosis, and multiple aesthetic conditions, some with no currently approved products, including the reduction of fine lines, pore size, sebum production and improvement in luminosity and overall skin quality.
−Removed: We believe these diseases and conditions cause significant negative impacts on patients’ quality of life, including physical and emotional trauma and social stigmatism, causing patients to constantly seek better treatment options to help alleviate their conditions.
+Added: We are currently focused on the medical and aesthetic dermatology markets, which include multiple common and undertreated skin diseases and conditions such as acne, psoriasis, hyperhidrosis, and multiple aesthetic skin conditions, some with no currently approved products, including the reduction of fine lines, pore size, sebum production and improvement in luminosity and overall skin quality.
+Added: We believe these diseases and conditions cause significant negative impacts on patients’ quality of life, including physical and emotional trauma and social stigmatism, causing patients to constantly seek better treatment options to help improve their conditions.
We also believe these markets have not experienced the same level of development and advances as other markets, as there have been few innovative topical products recently approved other than reformulations or combinations of existing compounds.
−Removed: We believe our product candidates will be well situated within the market and offer the innovative solutions to the underserved medical and aesthetic dermatology markets.
+Added: We believe our product candidates will be well situated within the market and offer innovative solutions to the underserved medical and aesthetic dermatology markets.
medical dermatology market has experienced significant growth in recent years based on the new treatment options and greater patient access to care.
Based on current market data, the U.S.
−Removed: medical dermatology market (excluding biologics) was valued at over $16 billion dollars in prescription pharmaceutical sales in 2020.
−Removed: The American Society of Plastic Surgeons estimates that over 15.4 million cosmetic procedures were performed in the U.S.
+Added: medical dermatology market was valued at over $8.3 billion dollars in in 2024 and estimated to be worth over $9.2 billion by 2028.
+Added: The American Society of Plastic Surgeons estimates that over 25 million minimally invasive cosmetic procedures were performed in the U.S.
in 2023 of which about 9.5 million used botulinum toxin.
−Removed: There are many factors that continue to drive growth in the aesthetics dermatology market such as greater patient acceptance, including from an increase in younger patients, and the discretionary cash that patients are willing to spend on aesthetic care.
+Added: There are many factors that continue to drive growth in the aesthetics dermatology market such as greater patient acceptance, including from younger patients, and the discretionary cash that patients are willing to spend on aesthetic skin care.
We also believe patients have a growing willingness to pay out-of-pocket for effective skin treatments to achieve their desired personal aesthetic look, which further supports the demand and pricing in those markets.
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While it grows in many parts of the northern hemisphere, there are only certain locations where it grows in the quantities and of the quality to viably support a commercial pharmaceutical product.
−Removed: One such location is the Volga River in central Russia, where we have signed an exclusive supply agreement with one of the larger known suppliers of Spongilla raw material for DMT310, which we believe provides us with a reliable source of our supply of Spongilla raw material for the foreseeable future.
+Added: One such location is the Volga River in central Russia, where we have signed an exclusive supply agreement with one of the larger known suppliers of Spongilla raw material for XYNGARI™, which we believe provides us with a reliable source of our supply of Spongilla raw material for the foreseeable future.
Traditionally, locals would harvest small amounts of Spongilla for its perceived medicinal properties and use it as a folk medicine to treat a variety of inflammatory conditions, including arthritis.
−Removed: Over the last 21 years, our exclusive supplier has refined its harvesting methods and procedures and is now capable of supplying a high-quality raw material.
+Added: Over the last 22 years, our exclusive supplier has refined its harvesting methods and procedures and is now capable of supplying a high-quality raw material that meets our release criteria, year-over-year.
Our supplier has the capacity to collect and process large quantities of Spongilla per year.
−Removed: We believe our supplier will be able to supply a raw material in the quantities and of the quality necessary to support our clinical and commercial needs.
+Added: We believe our supplier will be able to supply raw material in the quantities and of the quality necessary to support our clinical and commercial needs.
+Added: Since entering into the exclusive supply agreement, we have consistently been able to order and receive quantities of raw material to support our ongoing development activities and prepare batches for filing of an NDA.
The traditional use of Spongilla in Russia has provided a large amount of safety data.
−Removed: In 2003, the Russian Ministry of Health indicated that Spongilla has been used by over one million people per year, with few reported safety issues.
+Added: In 2003, the Russian Ministry of Health indicated that Spongilla had been used by over one million people per year, with few reported safety issues.
In 2017, we submitted this safety information, along with various other publications and non-clinical studies, in an Investigational New Drug, or IND, application to the FDA’s Division of Dermatology and Dental Products with reference to the FDA’s Botanical Drug Development Guidance for Industry, or Botanical Guidance.
−Removed: This submission enabled the FDA to approve our IND for DMT310, allowing us to proceed directly into a Phase 2 clinical trial in patients due in part to historical human exposure.
−Removed: In 2023, the FDA also confirmed that DMT310 would be filed under a new drug application (NDA).
+Added: This submission enabled the FDA to approve our IND for XYNGARI™, allowing us to proceed directly into a Phase 2 clinical trial in patients due in part to this historical human exposure.
+Added: In 2023, the FDA also confirmed that XYNGARI™ would be filed under a NDA.
While we are still required to complete certain non-clinical and pharmacokinetic studies prior to filing an NDA, we were able to strategically conserve resources while gathering human clinical efficacy and safety data prior to completing such work.
+Added: We have since completed an End of Phase 2 Meeting with the FDA which provided us the approval to move into our first ongoing Phase 3 study and provided the framework necessary to file an NDA.
Spongilla’s Multiple Mechanism of Actions
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While Spongilla is technically a part of the animal kingdom, it grows and acts more similarly to a plant in that it can completely regenerate every year, even in harsh environmental conditions.
−Removed: In addition to causing a regrowth of the sponge each year, the harsh environmental conditions the sponge lives in helps contribute to our Spongilla technologies’ multiple mechanisms of actions.
−Removed: Based on knowledge gained from over 21 years of harvesting Spongilla , our supplier has learned the necessary environmental conditions and Spongilla characteristics that must be present for optimal raw material harvest and to ensure the raw material contains the necessary properties for an effective pharmaceutical product.
−Removed: These properties include both mechanical and chemical components that are a naturally occurring part of the sponge raw material and contribute to our Spongilla technology’s mechanisms of action in the treatment of skin diseases and conditions.
−Removed: The mechanical components of DMT310 come from the Spongilla ’s skeletal structure, which is made up of siliceous spicules that are bound together by organic material, as seen in Image 2 below.
−Removed: These spicules are smooth, rod-like shapes which come to a point on each end, and if the Spongilla is harvested under certain proprietary environmental conditions, the spicules can average between 150-300 micrometers in length and about 10-15 micrometers in diameter.
−Removed: While there are other types of freshwater and marine sponges, many of their spicules can be covered in barbs or hooks which we believe would get stuck in the skin or contain spicules that are blunt on each end, making skin penetration difficult.
+Added: In addition to causing a regrowth of the sponge each year, the harsh environmental conditions in which the sponge lives help contribute to our Spongilla technologies’ multiple mechanisms of actions.
+Added: Based on knowledge gained from over 22 years of harvesting Spongilla , our supplier can recognize the necessary environmental conditions and Spongilla characteristics to ensure optimal raw material harvest, maximizing the probability that the raw material contains the necessary properties for an effective pharmaceutical product.
+Added: These properties include both mechanical and chemical components that are naturally occurring parts of the sponge raw material and contribute to our Spongilla technology’s mechanisms of action in the treatment of skin diseases and conditions.
+Added: The mechanical components of XYNGARI™ come from the Spongilla ’s skeletal structure, which is made up of siliceous spicules that are bound together by organic material, as seen in Image 2 below.
+Added: These spicules are smooth, rod-like shapes which come to a point on each end, and if the Spongilla is harvested under our specified environmental conditions, the spicules can average between 150-300 micrometers in length and about 10-15 micrometers in diameter.
+Added: While there are other species of freshwater and marine sponges, many of their spicules can be covered in barbs or hooks, as seen in Image 3, which we believe would get stuck in the skin or contain spicules that are blunt on each end, making skin penetration difficult.
Siliceous Spicules Present in Spongilla
−Removed: After harvesting and further processing in the U.S., the form and size of our spicules make them the ideal mechanism to penetrate the stratum corneum, the skins barrier, and temporarily create a micro-channel into the dermis without penetrating into subcutaneous tissue, where the larger blood vessels are located.
+Added: Sponge Spicules
+Added: After harvesting and further processing in the U.S., the form and size of our spicules make them the ideal mechanism to penetrate the stratum corneum, the skins barrier, and temporarily create a micro-channel into the dermis without penetrating subcutaneous tissue, where the larger blood vessels are located.
These newly created microchannels temporarily open the skin’s barrier to allow for the targeted delivery of large and small chemical compounds into the dermis.
−Removed: Most topically applied products currently contain various penetration enhancers that help force the active molecule through the stratum corneum and into the dermis, such as Dimethyl Sulfoxide (DMSO).
+Added: Most topically applied products currently contain penetration enhancers that help force the active molecule through the stratum corneum and into the dermis, such as Dimethyl Sulfoxide (DMSO).
However, DMSO is only able to help smaller molecules penetrate and is usually unable to aid larger molecules, such as botulinum toxin, in topical delivery.
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Most currently approved topical dermatology products are reviewed solely by the FDA’s Office of Dermatology and Dental Products and follow a standard approval pathway.
−Removed: However, due to our lead product candidate, DMT310, being derived from a natural source, it will be reviewed by the FDA Office of Dermatology and Dental Products with input from the FDA Botanical Review Division.
+Added: However, due to our lead product candidate, XYNGARI™, being derived from a natural source, it will be reviewed by the FDA Office of Dermatology and Dental Products with input from the FDA Botanical Review Division.
While Spongilla is not a botanical, the FDA has allowed us to reference the Botanical Guidance for raw material quality control and batch to batch consistency through development and into commercialization.
−Removed: We believe our ability to reference the Botanical Guidance and receive input from the Botanical Review Division on DMT310 provides us with key advantages in DMT310’s regulatory pathway to approval, if achieved.
+Added: We believe our ability to reference the Botanical Guidance and receive input from the Botanical Review Division on XYNGARI™ provides us with key advantages in XYNGARI’s™ regulatory pathway to approval, if achieved.
These advantages include being able to move into human clinical studies upon the FDA’s acknowledged receipt of our IND letter and subsequent study may proceed, saving us substantial financial resources to achieve human clinical data.
Additionally, while we believe that our sponge contains multiple active chemical compounds, based on our regulatory analysis of the feedback from the FDA and the Botanical Guidance, we believe we are only required to provide identifiable and quantifiable active components to show quality control and batch to batch consistency.
−Removed: We believe this will make it more difficult for potential competitors to replicate DMT310 due to their inability to know every component of our product candidate and to show their product is similar in its composition.
−Removed: Thus, we believe a competitor with a similar product or product candidate would have to follow all the manufacturing, development, and regulatory steps we must complete for approval.
−Removed: However, there can be no assurance that we successfully navigate the development of DMT310 or that DMT310 will receive FDA approval.
+Added: We believe this will make it more difficult for potential competitors to replicate XYNGARI™ due to their inability to know every component of our product candidate and to show their product is similar in its composition.
+Added: Thus, we believe a competitor with a similar product or product candidate would have to follow all the manufacturing, development, and regulatory steps we must complete for FDA approval.
+Added: However, there can be no assurance that we successfully navigate the development of XYNGARI™ or that XYNGARI™ will receive FDA approval.
Our Product Candidates
−Removed: Our lead product candidate, DMT310, is a unique, once weekly, naturally derived topical product, first being developed for the treatment of moderate-to-severe acne vulgaris, or acne.
+Added: Our lead product candidate, XYNGARI™, is a unique, once weekly, naturally derived topical product, first being developed for the treatment of moderate-to-severe acne, or acne.
It is derived from freshwater Spongilla lacustris , or Spongilla , which grows under certain environmental conditions in select locations throughout the northern hemisphere .
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Immediately prior to treatment the patient will mix the powder with a diluent (hydrogen peroxide) to form a paste, which the patient can then apply to the treatment area to treat the multiple facets of their disease.
−Removed: DMT310 utilizes the Spongilla’s mechanical spicules to help resurface a patient’s skin while also creating microchannels through the stratum corneum to allow the penetration of the Spongilla’s naturally created organic compounds to help treat various skin diseases.
+Added: XYNGARI™ utilizes the Spongilla’s mechanical spicules to help resurface a patient’s skin while also creating microchannels through the stratum corneum to allow the penetration of the Spongilla’s naturally created organic compounds to help treat various skin diseases.
We believe these organic compounds can travel through the newly created microchannels into the dermis and sebaceous glands where both inflammatory and non-inflammatory acne lesions originate.
−Removed: DMT310 targets treatment of the multiple facets of acne by combining the substantial mechanical and chemical activity of Spongilla into an easy to apply product that only needs to be applied once weekly.
−Removed: If approved by the FDA, we believe the combination of the mechanical and chemical properties of DMT310 has the potential for a more rapid time to treatment effect with fewer treatments, less side effects, and better tolerability than other currently marketed topical acne products.
−Removed: DMT310 for Treatment of Acne Vulgaris
+Added: XYNGARI™ targets treatment of the multiple facets of acne by combining the substantial mechanical and chemical activity of Spongilla into an easy to apply product that only needs to be applied once weekly.
+Added: If approved by the FDA, we believe the combination of the mechanical and chemical properties of XYNGARI™ has the potential for a more rapid time to treatment effect with fewer treatments, less side effects, and better tolerability than other currently marketed topical acne products.
+Added: XYNGARI™ for Treatment of Acne
Market Opportunity .
Acne is characterized by areas of scaly red skin, non-inflammatory blackheads and whiteheads, inflammatory lesions, papules, and pustules and occasionally cysts and scarring that occur on the face, neck, chest, back, shoulders, and upper arms.
−Removed: It affects approximately 50 million people in the U.S., with about 85% of teenagers experiencing some form of acne.
+Added: It affects approximately 50 million people in the U.S., with an estimated 32.6 million diagnosed cases in the U.S.
+Added: in 2023, with about 85% of teenagers in the U.S.
+Added: experiencing some form of acne.
prescription acne market had approximately $2.6 billion in prescription pharmaceutical sales in 2016 and is expected to reach approximately $3.8 billion in 2026 according to GlobalData Inc.
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While not life-threatening, acne causes significant trauma for those suffering from it due to social stigmas, substantial risk of permanent facial scarring, lowered self-esteem and social withdrawal.
−Removed: Therefore, we believe early and aggressive treatment with an effective once weekly product may lessen the overall long-term impact of this disease and may lead to an increase in a patient’s quality of life.
−Removed: Due to acne’s negative impact on a patient’s quality of life and negative impact on facial aesthetic, patients suffering from acne tend to be highly motivated to treat their acne and we believe willing to pay more out-of-pocket for higher priced and highly effective treatments.
−Removed: It is our belief that patients seeking an easy to use and effective topical product will tolerate less favorable reimbursement rates than for other prescription products for other indications, allowing for favorable pricing if we are able to eventually obtain approval for and successfully commercialize DMT310 for acne.
−Removed: Furthermore, if approved, we believe that DMT310’s natural characteristics may allow us to expand our addressable acne market to include those patients who value using naturally derived products, such as DMT310.
+Added: Therefore, we believe early and aggressive treatment with an effective, once weekly, topical product may lessen the overall long-term impact of this disease and may lead to an increase in a patient’s quality of life.
+Added: Due to acne’s negative impact on a patient’s quality of life and negative impact on facial aesthetic, patients suffering from acne tend to be highly motivated to treat their acne and we believe willing to pay more out-of-pocket for higher priced and highly effective treatment, like XYNGARI™.
+Added: It is our belief that patients seeking an easy to use and effective topical product will tolerate less favorable reimbursement rates than for other prescription products for other indications, allowing for favorable pricing if we are able to eventually obtain approval for and successfully commercialize XYNGARI™ for acne.
+Added: Furthermore, if approved, we believe that XYNGARI™ natural characteristics may allow us to expand our addressable acne market to include those patients who value using naturally derived products, such as XYNGARI™.
The acne market can be broken into three separate classes based on the severity of the acne:
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Our Solution for Moderate-to-Severe Acne.
−Removed: If approved, we believe DMT310’s once weekly application regimen and apparent rapid treatment effect will increase patient compliance, potentially increasing the likelihood of improved acne results.
−Removed: Using our multifaceted, once weekly Spongilla treatment technology, we are developing DMT310 to create a paradigm shift in how acne is treated by dermatologists by attempting to make DMT310 the preferred treatment option for all acne patients.
−Removed: We have designed DMT310 to treat the multiple factors of acne while also attempting to increase patient compliance.
−Removed: If approved, we believe DMT310 has the potential to remedy many of the negative characteristics associated with current topical therapies for moderate-to-severe acne vulgaris, including cumbersome treatment regimens, negative side effects (including burning, stinging, itching or dryness, which may occur as early as the first treatment and continue daily thereafter), and delayed time to effectiveness (which may take up to eight weeks).
−Removed: DMT310 is designed to be applied only once a week, rather than once or twice a day.
+Added: If approved, we believe XYNGARI’s™ once weekly application regimen and apparent rapid treatment effect will increase patient compliance, potentially increasing the likelihood of improved acne results.
+Added: Using our multifaceted, once weekly Spongilla treatment technology, we are developing XYNGARI™ to create a paradigm shift in how acne is treated by dermatologists by attempting to make XYNGARI™ the preferred treatment option for all acne patients.
+Added: We have designed XYNGARI™ to treat the multiple factors of acne while also attempting to increase patient compliance through ease of use and acceptable tolerability profile.
+Added: If approved, we believe XYNGARI™ has the potential to remedy many of the negative characteristics associated with current topical therapies for moderate-to-severe acne, including cumbersome treatment regimens, negative side effects (including burning, stinging, itching or dryness, which may occur as early as the first treatment and continue daily thereafter), and delayed time to effectiveness (which may take up to eight weeks).
+Added: XYNGARI™ is designed to be applied only once a week, rather than once or twice a day.
We believe a once weekly schedule may be conducive to high patient compliance as it is less onerous for the patient.
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Further, approximately 90% of patients had no, or mild, tolerability issues at the end of the 12-week trial and no patients experienced any severe tolerability issues.
−Removed: In addition, in our Phase 2b trial we observed that DMT310 started showing a statistically significant difference from placebo for all three endpoints after just four treatments while also having a rapid reduction on inflammatory and non-inflammatory lesions.
+Added: In addition, in our Phase 2b trial we observed that XYNGARI™ started showing a statistically significant difference from placebo for all three endpoints after just four treatments while also having a rapid reduction on inflammatory and non-inflammatory lesions.
We believe this rapid visible response encouraged patients to continue to comply with the once weekly application schedule leading to a continued reduction in their lesions until the end of trial at week 12.
−Removed: Thus, we believe that a topical product that only needs to be applied once weekly with a quicker time to perceived treatment effect and fewer tolerability issues has the opportunity to exhibit greater treatment success due to improved patient compliance leading to loyal and repeat users.
−Removed: DMT310 for the Treatment of Mild-to-Moderate Psoriasis
−Removed: We believe that DMT310 could also be an effective treatment for mild-to-moderate psoriasis based on the clinical data received from our recently completed Phase 1b POC trial and the in-vitro effect DMT310 has shown on the down regulation of IL-17A and IL-17F, as well as its ease of application to mild-to-moderate psoriatic lesions with smaller surface areas.
+Added: Thus, we believe that a topical product that only needs to be applied once weekly with a quicker time to perceived treatment effect and fewer tolerability issues may result in greater treatment success due to improved patient compliance leading to loyal and repeat users.
+Added: XYNGARI™ for the Treatment of Mild-to-Moderate Psoriasis
+Added: We believe that XYNGARI™ could also be an effective treatment for mild-to-moderate psoriasis based on the clinical data received from our Phase 1b POC trial and the in-vitro effect XYNGARI™ has shown on the down regulation of IL-17A and IL-17F, as well as its ease of application to mild-to-moderate psoriatic lesions with smaller surface areas.
Psoriasis is characterized by “plaques,” or raised red areas of skin covered with a silver or white layer of dead skin cells referred to as “scales.” Psoriatic plaques can appear on any area of the body, but most often appear on the scalp, knees, elbows, trunk, and limbs, and the plaques are often itchy and sometimes painful.
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These activated T cells and the inflammatory cytokines they secrete are believed to induce the skin lesions seen in psoriasis.
−Removed: In addition to the broad anti-inflammatory properties, we have observed in our clinical acne studies, DMT310’s ability exhibited in-vitro a dose dependent inhibition of both IL-17A and IL-17F, key cytokines implicated in the pathogenesis of psoriasis.
−Removed: Thus, DMT310 may provide a method to topically deliver targeted anti-inflammatory therapy directly to psoriatic lesions with good local tolerability in an easy to apply regimen.
+Added: In addition to the broad anti-inflammatory properties, we have observed in our clinical acne studies, XYNGARI’s™ ability exhibited in-vitro a dose dependent inhibition of both IL-17A and IL-17F, key cytokines implicated in the pathogenesis of psoriasis.
+Added: Thus, XYNGARI™ may provide a method to topically deliver targeted anti-inflammatory therapy directly to psoriatic lesions with good local tolerability in an easy to apply regimen.
Market Opportunity.
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The treatments for mild psoriasis patients are mostly generic but are often inadequate to control a patient’s disease.
−Removed: Mild psoriasis patients are first treated with topical therapies due to the reduced systemic exposure.
+Added: Mild psoriasis patients are first treated with topical therapies, like Vtama, Zoryve, Opzelure, and Eucrisa, due to the reduced systemic exposure.
However, patients often feel that topical treatments are one of the negative aspects of psoriasis, which we believe is partly due to the limited options available like, coal tar, retinoids, calcineurin inhibitors and corticosteroids.
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Similar to the needs of patients with acne, we believe patients suffering with psoriasis might comply better with a treatment that is easy to apply and requires less application time than current treatment options.
−Removed: DMT310, if approved, could be used as a first line therapy for patients with mild-to-moderate psoriasis.
−Removed: We believe the spicules within DMT310 will help break up the psoriatic lesions, while the anti-inflammatory components of DMT310 assist with the healing of the lesions.
−Removed: Due to the historical use of Spongilla and the human safety data collected to date in our clinical studies, we believe DMT310 may be suitable for long term treatment of chronic psoriasis due to its unique treatment effect and acceptable safety and tolerability profile.
−Removed: In addition to the mechanical effects of DMT310, extracts of the organic material have shown in-vitro to have a dose dependent inhibition of IL-17A and IL-17F secretion.
+Added: XYNGARI™, if approved, could be used as a first line therapy for patients with mild-to-moderate psoriasis.
+Added: We believe the spicules within XYNGARI™ will help break up the psoriatic lesions, while the anti-inflammatory components of XYNGARI™ assist with the healing of the lesions.
+Added: Due to the historical use of Spongilla and the human safety data collected to date in our clinical studies, we believe XYNGARI™ may be suitable for long term treatment of chronic psoriasis due to its unique treatment effect and acceptable safety and tolerability profile.
+Added: In addition to the mechanical effects of XYNGARI™, extracts of the organic material have shown in-vitro to have a dose dependent inhibition of IL-17A and IL-17F secretion.
In the dermis and epidermis, T lymphocytes interact with antigen-presenting cells and secrete Th1 and Th17 cytokines, including interferon-gamma (IFN-g), interleukin (IL)-2, IL-17, IL-22, and tumor necrosis factor alpha (TNF-α).
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Therefore, a topical product that can inhibit the IL-17 pathway in the skin with minimal systemic exposure would be an ideal option for both physicians and patients.
−Removed: Based on clinical and non-clinical data generated to date for DMT310, and anecdotal evidence of DMT310’s effect on psoriatic lesions, we completed a Phase 1b, open label, POC study in mild-to-moderate psoriasis patients in October 2021.
−Removed: This trial included once weekly treatments of DMT310 for 12 weeks in 30 mild-to-moderate psoriasis patients with lesions covering 2% to 30% of their body surface area.
+Added: Based on clinical and non-clinical data generated to date for XYNGARI™, and anecdotal evidence of XYNGARI™ ’s effect on psoriatic lesions, we completed a Phase 1b, open label, POC study in mild-to-moderate psoriasis patients in October 2021.
+Added: This trial included once weekly treatments of XYNGARI™ for 12 weeks in 30 mild-to-moderate psoriasis patients with lesions covering 2% to 30% of their body surface area.
The primary endpoints in this trial were the Physician’s Global Assessment, which is a 6-point scale measuring the physician’s assessment of psoriasis severity of the target lesion site, the Psoriasis Area Severity Index scale is also a 6-point scale measuring the psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness, and scaling) and degree of surface area involvement and the Pruritus Visual Analog Scale consists of the patient’s measurement of pruritus, or itch, in addition to normal tolerability and safety assessments.
We announced top-line results in October 2021, and based on the efficacy, safety and tolerability profile seen in the POC trial we initiated additional work to better inform the clinical trial design prior to moving into a larger Phase 2, placebo-controlled, clinical trial upon the receipt of sufficient financial resources.
−Removed: DMT310 for the Treatment of Moderate-to-Severe Rosacea
−Removed: On December 5, 2022, we announced topline results from our Phase 2 trial of once-weekly topical application of DMT310 for the treatment of moderate-to-severe rosacea.
−Removed: The data was supportive of DMT310 as a treatment for inflammatory skin diseases, but the rosacea study did not meet its primary endpoints.
−Removed: While some patients did achieve a meaningful change in their rosacea, with 36% of DMT310 patients meeting the criteria for a responder on the Investigator Global Assessment (IGA) score, DMT310 was not able to statistically separate from placebo with 23% of placebo patients meeting the criteria as a responder at Week 12.
−Removed: A treatment responder is defined as an IGA grade of ‘clear’ or ‘almost clear’ and at least a 2-grade improvement from baseline.
−Removed: We believe that the 23% dropout rate in the DMT310 group may have contributed to the outcome of this study.
−Removed: After further assessment of the data, we believe DMT310 may not be tolerable for rosacea patients, who tend to have more sensitive skin.
−Removed: Based on the foregoing, we have decided not to devote any further financial resources to development of this indication for DMT310, and we have determined not to pursue further development efforts regarding this indication for DM310.
−Removed: We will continue to focus our resources on our DMT310 program for acne based on the statistically significant results seen in our Phase 2b study.
DMT400 for the Topical Delivery of Macromolecules
−Removed: DMT400 is our combination treatment regimen that utilizes the unique mechanical features of our Spongilla technology to facilitate the intradermal delivery of macromolecules, such as botulinum toxin, monoclonal antibodies, dermal fillers, or vaccines, by topical application rather than with injections.
+Added: DMT400 is our treatment regimen that utilizes the unique mechanical features of our Spongilla technology to facilitate the intradermal delivery of macromolecules, such as botulinum toxin, monoclonal antibodies, dermal fillers, or vaccines, by topical application rather than with injections.
These macromolecules are highly effective and approved for the treatment of multiple medical and aesthetic skin conditions and diseases, but currently are not approved in a topical form because the molecular structures are too large to penetrate the stratum corneum, the skin’s outermost defense barrier.
−Removed: Thus, all current macromolecule treatment options for skin conditions and diseases must be injected, sometimes requiring numerous injections.
+Added: Thus, all current macromolecule treatment options for skin conditions and diseases must be injected, either intramuscularly or intradermally, sometimes requiring numerous injections.
We believe that DMT400’s topical application regimen may provide patients with a topical treatment option for both medical and aesthetic dermatology conditions using products previously unavailable to them in a topical treatment.
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Lastly, topical aluminum chloride treatment has a transient duration of effect and requires frequent reapplication to maintain sweat control.
−Removed: More recently, topical anticholinergics have been investigated by companies such as Botanix Inc.
+Added: More recently, topical anticholinergics have been investigated and approved, such as Botanix Inc.
(formerly developed by Fresh Tracks, Inc.) and Journey Medical Corporation (formerly developed by Dermira, Inc.), but we believe they tend to have the same side effects as systemic anticholinergics which are used off-label.
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Clinical Progress of our Lead Product Candidates
−Removed: DMT310 Phase 3 Clinical Trial Program for Acne
−Removed: In December 2023, we initiated the DMT310 Phase 3 clinical program entitled Spongilla Treatment of Acne Research study (STAR).
−Removed: The DMT310 Phase 3 clinical program will include two Phase 3 clinical trials to evaluate the efficacy, safety, and tolerability of DMT310 in patients with moderate-to-severe facial acne.
+Added: XYNGARI™ Phase 3 Clinical Trial Program for Acne
+Added: In December 2023, we initiated the XYNGARI™ Phase 3 clinical program entitled Spongilla Treatment of Acne Research study (STAR).
+Added: The XYNGARI™ Phase 3 clinical program will include two Phase 3 clinical trials to evaluate the efficacy, safety, and tolerability of XYNGARI™ in patients with moderate-to-severe facial acne.
Each Phase 3 trial will be randomized (2:1), double-blind, placebo-controlled, and will enroll approximately 500-600 patients with moderate-to-severe acne, ages 9 years and older in the United States and Latin America.
1 unchanged sentence
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).
−Removed: Patients will be treated once a week for 12 weeks with either DMT310 or placebo and will be evaluated monthly.
−Removed: STAR-1 is the first of two pivotal Phase 3 trials, with top-line results expected in the first quarter of 2025.
−Removed: Upon adequate financing, we will initiate the second Phase 3 clinical trial, STAR-2, which will be followed by a long-term extension study as required by FDA.
−Removed: If positive, the results from both Phase 3 clinical trials will be used to support the filing of an NDA with FDA.
−Removed: DMT310 Phase 2b Clinical Results for Acne
−Removed: In June 2020, we received results from our randomized, double-blind, placebo-controlled, Phase 2b clinical trial of once weekly treatments for twelve weeks of DMT310 for acne.
+Added: Patients will be treated once a week for 12 weeks with either XYNGARI™ or placebo and will be evaluated monthly.
+Added: STAR-1 is the first of two pivotal Phase 3 trials, with top-line results expected in March of 2025.
+Added: Upon adequate financing, we intend to initiate the second Phase 3 clinical trial, STAR-2, which we expect will be followed by a long-term extension study as required by FDA.
+Added: If positive, the results from the Phase 3 program will be used to support the filing of an NDA with FDA.
+Added: XYNGARI™ Phase 2b Clinical Results for Acne
+Added: In June 2020, we received results from our randomized, double-blind, placebo-controlled, Phase 2b clinical trial of once weekly treatments for twelve weeks of XYNGARI™ for acne.
We enrolled 181 moderate-to-severe acne patients at fourteen (14) sites across the U.S.
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The IGA scale consists of a 5-point scale, 0-4, with 0 being clear, 1 being almost clear and 4 being severe acne as graded by the treating physician.
−Removed: Patients were randomly divided into two treatment groups, either to receive DMT310 or placebo.
−Removed: Patients were required to apply the product, whether DMT310 or placebo, to the entire face, once weekly for 12 weeks with the first two weeks of treatment applied in office under the supervision of trained study staff, then the remaining 10 weekly treatments were applied at home by the patient.
+Added: Patients were randomly divided into two treatment groups, either to receive XYNGARI™ or placebo.
+Added: Patients were required to apply the product, whether XYNGARI™ or placebo, to the entire face, once weekly for 12 weeks with the first two weeks of treatment applied in office under the supervision of trained study staff, then the remaining 10 weekly treatments were applied at home by the patient.
The primary clinical endpoints of the trial included the absolute reduction in inflammatory lesions from baseline.
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In addition, both inflammatory and non-inflammatory percent reduction in lesion counts had P-values of less than 0.001 at week four and week 12 when compared to placebo.
−Removed: We also saw an early statistically significant separation in IGA with 15% of patients in the DMT310 group considered responders on the IGA scale, or who had an IGA score of 0, “clear,” or 1, “almost clear,” after only 4 treatments as compared with just over 2% of patients on placebo.
−Removed: This statistical separation continued for the remainder of the trial where at the completion of the trial, or week 12, 44% of patients in the DMT310 group, compared with 17% in the placebo group were IGA responders.
+Added: We also saw an early statistically significant separation in IGA with 15% of patients in the XYNGARI™ group considered responders on the IGA scale, or who had an IGA score of 0, “clear,” or 1, “almost clear,” after only 4 treatments as compared with just over 2% of patients on placebo.
+Added: This statistical separation continued for the remainder of the trial where at the completion of the trial, or week 12, 44% of patients in the XYNGARI™ group, compared with 17% in the placebo group were IGA responders.
This difference was statistically significant with a P-value of less than 0.001.
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Of those patients who did report tolerability issues, they also reported that the issues were usually transient and resolved quickly without intervention.
−Removed: Based on this data, after meeting with the FDA, we expect to proceed to Phase 3 clinical trials with the same clinical endpoints and the same formulation of DMT310 for moderate-to-severe acne.
−Removed: The following diagrams and tables show the absolute reduction of inflammatory and non-inflammatory lesions from baseline until the end of study, or week 12, for both DMT310 and placebo (Image 4), and percent reduction of inflammatory and non-inflammatory lesions from baseline until end of study, or week 12, for both DMT310 and Placebo (Image 5).
+Added: Based on this data, after holding an End of Phase 2 Meeting with FDA, we initiated the Phase 3 program in moderate-to-severe acne with the same clinical endpoints and the same formulation of XYNGARI™.
+Added: The following diagrams and tables show the absolute reduction of inflammatory and non-inflammatory lesions from baseline until the end of study, or week 12, for both XYNGARI™ and placebo (Image 5), and percent reduction of inflammatory and non-inflammatory lesions from baseline until end of study, or week 12, for both XYNGARI™ and Placebo (Image 6).
Although reduction in non-inflammatory lesions was a secondary endpoint of this trial, it is a required metric for the Phase 3 acne studies necessary for FDA approval.
−Removed: Mean reduction of inflammatory and non-inflammatory lesions from baseline until end of study, or week 12, for both DMT310 and Placebo
−Removed: Percent reduction of inflammatory and non-inflammatory lesions from baseline until end of study, or week 12, for both DMT310 and Placebo
+Added: Mean reduction of inflammatory and non-inflammatory lesions from baseline until end of study, or week 12, for both XYNGARI™ and Placebo
+Added: Percent reduction of inflammatory and non-inflammatory lesions from baseline until end of study, or week 12, for both XYNGARI™ and Placebo
Investigator Global Assessment response rate at Day 29, or week 4, Day 57, or week 8 and Day 85, or week 12
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“Success” is defined as an IGA score of “clear” or “almost clear” and a 2-grade change in IGA upon completion of the study.
−Removed: Additionally, the safety and tolerability profile of DMT310 appeared to be acceptable with a small number of patients experiencing treatment emergent adverse events as seen in Image 7 below.
−Removed: In this Phase 2b trial, no subject receiving treatment with DMT310 experienced a severe local skin reaction at study end nor did any patient undergo a dose modification.
+Added: Additionally, the safety and tolerability profile of XYNGARI™ appeared to be acceptable with a small number of patients experiencing treatment emergent adverse events as seen in Image 8 below.
+Added: In this Phase 2b trial, no subject receiving treatment with XYNGARI™ experienced a severe local skin reaction at study end nor did any patient undergo a dose modification.
Most tolerability issues were mild and resolved shortly after application without any rescue medication as seen in Image 8 below.
−Removed: Overall, DMT310 was generally safe and well tolerated by patients when applied once weekly for 12 weeks.
+Added: Overall, XYNGARI™ was generally safe and well tolerated by patients when applied once weekly for 12 weeks.
System Organ Class Preferred Team
+Added: XYNGARI™ (N=91)
General disorders and administration site conditions
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Local Tolerability
−Removed: DMT310 Phase 2a Clinical Results for Acne
−Removed: In 2018 we conducted the first clinical trial of DMT310, a randomized, double-blind, 2x2 factorial, placebo-controlled, Phase 2a clinical trial of DMT310 for the treatment of acne.
−Removed: We enrolled 121 patients to evaluate the tolerability, safety, and efficacy of DMT310 mixed with 3% H 2 O 2 following 12 weeks of topical administration in male and female patients with moderate-to-severe facial acne.
+Added: XYNGARI™ Phase 2a Clinical Results for Acne
+Added: In 2018 we conducted the first clinical trial of XYNGARI™, a randomized, double-blind, 2x2 factorial, placebo-controlled, Phase 2a clinical trial of XYNGARI™ for the treatment of acne.
+Added: We enrolled 121 patients to evaluate the tolerability, safety, and efficacy of DM XYNGARI™ T310 mixed with 3% H 2 O 2 following 12 weeks of topical administration in male and female patients with moderate-to-severe facial acne.
The study employed a 2x2 factorial design to assess the contribution of each component of the investigational product (i.e., Spongilla lacustris topical powder and 3% H 2 O 2 USP).
−Removed: This Phase 2a clinical trial employed the same clinical endpoints as our Phase 2b clinical trial of DMT310 for the treatment of acne, as discussed above.
−Removed: Patients were randomly divided into one of four treatment groups, DMT310 + 3% H 2 O 2 , DMT310 + Water, Placebo + 3% H 2 O 2 , or Placebo + Water (control).
+Added: This Phase 2a clinical trial employed the same clinical endpoints as our Phase 2b clinical trial of XYNGARI™ for the treatment of acne, as discussed above.
+Added: Patients were randomly divided into one of four treatment groups, XYNGARI™ + 3% H 2 O 2 , XYNGARI™ + Water, Placebo + 3% H 2 O 2 , or Placebo + Water (control).
The patients were required to apply the assigned study drug to their entire face up to once weekly for 12 weeks (84 days), beginning on Day 1 and through Day 78 (as applicable).
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Application Frequency Algorithm by Study Visit
−Removed: This Phase 2a trial showed statistically significant and clinically meaningful effects for its endpoint, absolute reduction in inflammatory lesions when comparing DMT310 + 3% H 2 O 2 and placebo + water (control) groups at both week 8 and week 12 or end of study.
−Removed: At week 12, DMT310 + 3% H 2 O 2 had a 16-lesion reduction from baseline while placebo + water had an 11 lesion reduction from baseline, with a p-value of less than 0.05.
+Added: This Phase 2a trial showed statistically significant and clinically meaningful effects for its endpoint, absolute reduction in inflammatory lesions when comparing XYNGARI™ + 3% H 2 O 2 and placebo + water (control) groups at both week 8 and week 12 or end of study.
+Added: At week 12, XYNGARI™ + 3% H 2 O 2 had a 16-lesion reduction from baseline while placebo + water had an 11 lesion reduction from baseline, with a p-value of less than 0.05.
Across all the treatment groups, there was a mean decrease from baseline (i.e., improvement) in the inflammatory and non-inflammatory lesion counts at Days 15, 29, 57, and 85.
−Removed: However, there were no statistically significant differences between the DMT310 + 3% H 2 O 2 group versus the placebo + water (control) group for the mean changes from baseline in non-inflammatory lesion counts.
−Removed: We did not observe a statistically significant difference between the DMT310 + 3% H 2 O 2 group and the placebo + water (control) group in the percentages of patients with IGA treatment success (IGA score of 1 or 0 and a 2-grade change) or patients with 1-grade or 2-grade improvements from baseline in IGA at any visit.
−Removed: At Day 85 in the DMT310 + 3% H 2 O 2 , DMT310 + water, placebo + 3% H 2 O 2 , and placebo + water groups, 29.6%, 20.0%, 27.6%, and 34.5% of patients had IGA treatment responders, respectively;
+Added: However, there were no statistically significant differences between the XYNGARI™ + 3% H 2 O 2 group versus the placebo + water (control) group for the mean changes from baseline in non-inflammatory lesion counts.
+Added: We did not observe a statistically significant difference between the XYNGARI™ + 3% H 2 O 2 group and the placebo + water (control) group in the percentages of patients with IGA treatment success (IGA score of 1 or 0 and a 2-grade change) or patients with 1-grade or 2-grade improvements from baseline in IGA at any visit.
+Added: At Day 85 in the XYNGARI™ + 3% H 2 O 2 , XYNGARI™ + water, placebo + 3% H 2 O 2 , and placebo + water groups, 29.6%, 20.0%, 27.6%, and 34.5% of patients had IGA treatment responders, respectively;
66.7%, 66.7%, 65.5%, and 55.2% of subjects had a 1-grade improvement from baseline in the IGA, respectively;
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Biweekly Treatment Schedule :
−Removed: Due to this being the first time DMT310 was studied in moderate-to-severe acne patients for 12 weeks, a conservative study design was chosen to ensure patient tolerability and safety while attempting to maintain efficacy.
+Added: Due to this being the first time XYNGARI™ was studied in moderate-to-severe acne patients for 12 weeks, a conservative study design was chosen to ensure patient tolerability and safety while attempting to maintain efficacy.
Therefore, we allowed IGA treatment responders (IGA score of 0 or 1) to move to a biweekly or every other week application schedule as discussed above.
−Removed: This resulted in 3 out of 27 patients in the DMT310 + 3% H 2 O 2 group and 0 out of 29 patients in the placebo + water group moving from an IGA score of 1 (treatment responder) at week 8 and regressing to an IGA score of 2 (treatment failure) at week 12.
−Removed: Therefore, our Phase 2b clinical trial of DMT310 in moderate-to-severe acne patients incorporated only once weekly applications for 12 weeks with no biweekly option.
+Added: This resulted in 3 out of 27 patients in the XYNGARI™ + 3% H 2 O 2 group and 0 out of 29 patients in the placebo + water group moving from an IGA score of 1 (treatment responder) at week 8 and regressing to an IGA score of 2 (treatment failure) at week 12.
+Added: Therefore, our Phase 2b clinical trial of XYNGARI™ in moderate-to-severe acne patients incorporated only once weekly applications for 12 weeks with no biweekly option.
No statistical or clinical difference was seen between the placebo + 3% H 2 O 2 and the placebo + water groups, which we believe indicates that 3% H 2 O 2 by itself does not have a treatment effect.
−Removed: DMT310 next steps for acne
−Removed: After receiving positive feedback and alignment with FDA from our End of Phase 2 meeting in June of 2023 we began enrolling patients in our DMT310 Phase 3 program in moderate-to-severe acne in December 2023.
−Removed: The DMT310 Phase 3 program will include two, multi-center, placebo-controlled trials with identical clinical endpoints as our recent successful Phase 2b clinical trial of DMT310 for the treatment of moderate-to-severe acne.
−Removed: Once we receive top-line results from both Phase 3 studies, assuming positive results, we plan to file a new drug application, or NDA, with the FDA shortly thereafter.
−Removed: This Phase 3 program is intended to be designed to demonstrate the safety and efficacy of the treatment of DMT310 relative to placebo for the treatment of moderate-to-severe acne.
+Added: XYNGARI™ next steps for acne
+Added: After receiving positive feedback and alignment with FDA from our End of Phase 2 meeting in June of 2023 we began enrolling patients in our XYNGARI™ Phase 3 STAR-1 clinical trial in moderate-to-severe acne in December 2023.
+Added: The XYNGARI™ Phase 3 program will include two, multi-center, placebo-controlled trials with identical clinical endpoints as our recent successful Phase 2b clinical trial of XYNGARI™ for the treatment of moderate-to-severe acne, followed by a long-term extension study.
+Added: Once we receive results from the Phase 3 program, assuming positive results, we plan to file an NDA with the FDA shortly thereafter.
+Added: This Phase 3 program is intended to be designed to demonstrate the safety and efficacy of the treatment of XYNGARI™ relative to placebo for the treatment of moderate-to-severe acne.
Prior to, or in parallel with our planned Phase 3 program, we intend to continue conducting and complete the additional non-clinical studies necessary to support the filing of an NDA.
−Removed: We also intend to conduct a long-term safety study following the second Phase 3 clinical study.
−Removed: If DMT310 is approved for the treatment of acne, we believe DMT310 can eventually be an attractive prescription to over-the-counter switch, or Rx-to-OTC, target, which could provide a substantially larger sales opportunity.
−Removed: There can be no assurance that DMT310 will receive FDA approval for the treatment of acne.
−Removed: DMT310 Phase 1a Clinical Results for Psoriasis
−Removed: We completed a Phase 1a POC trial of DMT310 for the treatment of mild-to-moderate psoriasis.
+Added: If XYNGARI™ is approved for the treatment of acne, we believe XYNGARI™ can eventually be an attractive prescription to over-the-counter switch, or Rx-to-OTC, target, which could provide a substantially larger sales opportunity.
+Added: There can be no assurance that XYNGARI™ will receive FDA approval for the treatment of acne.
+Added: XYNGARI™ Phase 1a Clinical Results for Psoriasis
+Added: We completed a Phase 1a POC trial of XYNGARI™ for the treatment of mild-to-moderate psoriasis.
This was an open-label, multi-center, 12-week study in 30 mild-to-moderate psoriasis patients with psoriatic lesions covering between 2-30% of body surface area.
−Removed: The trial aimed at evaluating the tolerability, safety, and efficacy of once weekly treatments of DMT310, which consists of 2 grams of Spongilla powder mixed with 6 mL of 3% H 2 O 2 .
−Removed: One mild or moderate lesion was selected, and patients were required to apply DMT310 to the entire lesion, once weekly for 12 weeks with the first two weeks of treatment applied in office under the supervision of trained staff, then the remaining 10 weekly treatments were applied at home by the patient.
+Added: The trial aimed at evaluating the tolerability, safety, and efficacy of once weekly treatments of XYNGARI™, which consists of 2 grams of Spongilla powder mixed with 6 mL of 3% H 2 O 2 .
+Added: One mild or moderate lesion was selected, and patients were required to apply XYNGARI™ to the entire lesion, once weekly for 12 weeks with the first two weeks of treatment applied in office under the supervision of trained staff, then the remaining 10 weekly treatments were applied at home by the patient.
The endpoints in this study included:
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All efficacy analyses were performed using the As-Treated population, which consists of all enrolled patients who received at least one dose of study medication and the per protocol population, which consists of all enrolled patients with no significant protocol violations during the study that would affect the efficacy analyses.
−Removed: The trial was completed in August 2021 and showed an acceptable safety and tolerability profile that we believe is clinically meaningful and warrants further investigation of DMT310 as a potential treatment for mild-to-moderate psoriasis.
−Removed: DMT310 was able to achieve a PGA score of 0 or 1 for the target lesion in 29.6% of patients at week 8.
−Removed: DMT310 also demonstrated a total PASI score of 0 or 1 for the target lesion in 25.9% of patients at week 8.
−Removed: Notably, DMT310 demonstrated a 19.6% reduction from baseline in pruritus (itch) at week 8 with a peek reduction of 22.5%.
−Removed: We believe these findings from a POC trial are encouraging for the potential use of DMT310 as an easy to apply topical treatment for mild-to-moderate psoriasis with an acceptable safety and tolerability profile.
+Added: The trial was completed in August 2021 and showed an acceptable safety and tolerability profile that we believe is clinically meaningful and warrants further investigation of XYNGARI™ as a potential treatment for mild-to-moderate psoriasis.
+Added: XYNGARI™ was able to achieve a PGA score of 0 or 1 for the target lesion in 29.6% of patients at week 8.
+Added: XYNGARI™ also demonstrated a total PASI score of 0 or 1 for the target lesion in 25.9% of patients at week 8.
+Added: Notably, XYNGARI™ demonstrated a 19.6% reduction from baseline in pruritus (itch) at week 8 with a peek reduction of 22.5%.
+Added: We believe these findings from a POC trial are encouraging for the potential use of XYNGARI™ as an easy to apply topical treatment for mild-to-moderate psoriasis with an acceptable safety and tolerability profile.
No reported drug-related severe adverse events were reported in the trial and only two treatment emergent adverse events were reported, both being application site pruritus.
1 unchanged sentence
Of those patients who did report tolerability issues, they also reported that the issues were usually transient and resolved quickly without intervention.
−Removed: Local Tolerability
−Removed: DMT310 next steps for psoriasis
+Added: XYNGARI™ next steps for psoriasis
We are pleased with data already seen in our Phase 1 POC trial, especially seeing a reduction in itch as that is one of the main complaints of patients suffering from psoriasis.
−Removed: We are in the process of designing a Phase 2 study of DMT310 for the treatment of psoriasis.
−Removed: The Phase 2 study will be a larger randomized, double-blind, placebo control study of DMT310 for the treatment of psoriasis.
+Added: We are in the process of designing a Phase 2 study of XYNGARI™ for the treatment of psoriasis.
+Added: The Phase 2 study will be a larger randomized, double-blind, placebo control study of XYNGARI™ for the treatment of psoriasis.
Based on the data from the Phase 1b proof of concept study we are considering adding additional arms to examine once versus twice weekly treatment, potentially enhancing the treatment effect seen in our Phase 1b trial.
1 unchanged sentence
We believe that the thicker psoriatic plaques may require a more intensive treatment compared to the application regimen for acne where there is no thickened skin.
−Removed: We believe DMT310 could be a first in class treatment option for psoriasis patients.
−Removed: The DMT310 program for psoriasis is currently on hold with further advancement subject to obtaining additional financing and/or a strategic partner.
−Removed: There can be no assurance that DMT310 will receive FDA approval for the treatment of psoriasis.
+Added: We believe XYNGARI™ could be a first in class treatment option for psoriasis patients.
+Added: The XYNGARI™ program for psoriasis is currently on hold with further advancement subject to obtaining additional financing and/or a strategic partner.
+Added: There can be no assurance that XYNGARI™ will receive FDA approval for the treatment of psoriasis.
DMT410 Phase 1b-Primary Axillary Hyperhidrosis
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Treatment with DMT410 also had an acceptable safety and tolerability profile.
−Removed: We plan to partner with a botulinum toxin to run a larger Phase 2 study of DMT410 for axillary hyperhidrosis and possibly for palmar (hand) or plantar (foot) hyperhidrosis where there is currently no approved product.
+Added: On January 17, 2025, we entered into the Clinical Trial Agreement with Revance Therapeutics, Inc.
+Added: (Revance), who recently merged with Crown Laboratories, pursuant to which we in collaboration with Revance intend to conduct a multi-center clinical trial to evaluate the topical application of XYNGARI™, with DAXXIFY®.
+Added: Under the Clinical Trial Agreement, we intend to sponsor, conduct, and fund a Phase 2a clinical trial to evaluate the safety, tolerability and preliminary efficacy of XYNGARI™ and DAXXIFY® versus XYNGARI™ and placebo in patients with moderate-to-severe axillary hyperhidrosis for 16 weeks.
+Added: The Revance Trial is anticipated to be randomized (1:1:1:1), double-blind, placebo-controlled, and intends to enroll approximately 48 patients across sites in the United States.
+Added: The endpoints are anticipated to be (i) the percent of patients with greater than 50% reduction in gravimetrically measured sweat production from baseline, (ii) the percent of patients with gravimetric sweat production less than 50mg, and (iii) the mean absolute change from baseline in gravimetrically measured sweat production.
+Added: Patients are anticipated to be evaluated at four regular intervals.
+Added: Under the Clinical Trial Agreement, we and Revance will form a joint development committee to facilitate communications between the parties related to the Revance Trial.
+Added: If successful, we plan to explore a broader partnership with Revance to study DMT410 in additional indications.
There can be no assurances that DMT410 will receive FDA approval for the treatment of hyperhidrosis.
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We know that botulinum toxin has shown efficacy of these endpoints but there has been very little research conducted on the optimal dose or administration procedure, likely due to challenges with intradermal injections and the lack of topical applications that can effectively deliver botulinum toxin to a large enough treatment area as required to treat many of these aesthetic skin conditions.
−Removed: We believe DMT410 can meet this need as shown by our Phase 1b data, so we are actively discussing partnership opportunities with botulinum toxin companies that may be interested in helping us further develop our DMT410 program for multiple aesthetic skin conditions.
−Removed: There can be no assurances that we are able to successfully negotiate a partnership with a botulinum toxin company or that DMT410 will receive FDA approval for the treatment of any aesthetic skin conditions.
+Added: We believe DMT410 can meet this need as shown by our Phase 1b data, so we continue to discuss partnership opportunities with Revance and other botulinum toxin companies that may be interested in helping us further develop our DMT410 program for multiple aesthetic skin conditions.
+Added: There can be no assurances that we are able to successfully negotiate a partnership with a botulinum toxin company for aesthetic skin conditions or that DMT410 will receive FDA approval for the treatment of any aesthetic skin conditions.
Manufacturing
6 unchanged sentences
We believe our supplier is able to and will continue to be able to harvest sufficient quantities of raw material to fulfill our development and potential commercial needs, if a product candidate is approved using this raw material.
−Removed: We received multiple shipments of Spongilla raw material from our supplier during fiscal years 2022 and 2023 containing additional quantities of Spongilla raw material, which we believe will provide us with sufficient quantities of Spongilla to initiate and complete two Phase 3 studies in moderate-to-severe acne and support the filing of an NDA for DMT310 in acne in the event of successful completion of the two Phase 3 studies.
+Added: We received multiple shipments of Spongilla raw material from our supplier during fiscal years 2023 and 2024 containing additional quantities of Spongilla raw material, which we believe will provide us with sufficient quantities of Spongilla to initiate and complete the Phase 3 program in moderate-to-severe acne, complete a Phase 2b trial of DMT410 in axillary hyperhidrosis and support the filing of an NDA for XYNGARI™ in acne in the event of successful completion of the two Phase 3 studies.
However, we are exploring alternative manufacturing sources in order to ensure that we have access to sufficient manufacturing capacity to meet potential demand for any of our product candidates in a cost-efficient manner.
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The relevant manufacturers of our drug product candidates have advised us that they are in compliance with both current Good Laboratory Practices, or cGLP, and cGMP.
−Removed: We have relied upon our complete supply chain while supporting both our Phase 1 and Phase 2 clinical supply requirements and we are confident that our manufacturers have the ability to scale our processes to support our Phase 3 clinical studies and future commercial commitments.
−Removed: Our suppliers and manufactures were specifically selected based on the capabilities of their organization, their compliance to regulations, their personnel and the type and capabilities of their equipment.
+Added: We have relied upon our complete supply chain while supporting our Phase 2 and Phase 3 clinical supply requirements and we are confident that our manufacturers have the ability to scale our processes to support our future commercial requirements.
+Added: Our suppliers and manufacturers were specifically selected based on the capabilities of their organization, their compliance to regulations, their personnel and the type and capabilities of their equipment.
Testing methods for each stage of the manufacturing process form acquisition of raw materials through production of finished drug product have been developed and satisfactorily qualified per the FDA’s phase appropriate regulations relating to clinical materials for human use.
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Given our stage of development, we do not currently have any internal sales, marketing, or distribution infrastructure or capabilities.
−Removed: If approved, we intend to commercialize DMT310, or any other product candidates that we may successfully develop, in the United States by building a specialized sales organization focused on dermatologists.
+Added: If approved, we intend to commercialize XYNGARI™, or any other product candidates that we may successfully develop, in the United States by building a specialized sales organization focused on dermatologists or partnering with a company that has an already established sales force focused on dermatologists.
We believe a scientifically oriented, customer-focused team of approximately 50-60 sales representatives would allow us to reach our targeted dermatologists in the U.S.
−Removed: with the highest potential for prescribing DMT310.
−Removed: In the future, we may develop and commercialize DMT310 for additional geographic regions, independently or with a strategic partner.
−Removed: If DMT310 is approved, and we are able to successfully commercialize it, we believe DMT310 can eventually become an attractive Rx-to-OTC switch target, which could provide a substantially larger addressable market and an expanded sales opportunity.
+Added: with the highest potential for prescribing XYNGARI™.
+Added: In the future, we may develop and commercialize XYNGARI™ for additional geographic regions, independently or with a strategic partner.
+Added: If XYNGARI™ is approved, and we are able to successfully commercialize it, we believe XYNGARI™ can eventually become an attractive Rx-to-OTC switch target, which could provide a substantially larger addressable market and an expanded sales opportunity.
The medical and aesthetic pharmaceutical industries in which we plan to operate are competitive and subject to changes in practice.
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Our products may be rendered obsolete or may lack economic viability in the face of competition.
−Removed: The key competitive factors affecting the success of DMT310, if approved, will likely be its efficacy, safety, convenience of administration and delivery, price, and the availability of reimbursement from government and other third-party payors.
−Removed: With respect to DMT310 for the treatment of moderate-to-severe acne, if approved, we will primarily be competing with therapies such as other topical products, oral products, in-office procedures, such as laser surgery, off-label drugs, over the counter medication and homeopathic remedies.
−Removed: With regards to DMT310 for the treatment of mild-to-moderate psoriasis, if approved, we will face competition from topical therapies, oral therapies, systemic therapies, photo therapies and homeopathic treatments.
−Removed: However, based on our clinical trials, we believe that DMT310 has multiple competitive advantages over current treatment alternatives with significantly less adverse side effects.
−Removed: Our main competition in these indications will be with products from Sun Pharmaceuticals Industries Ltd., Vyne Therapeutics, Inc, Sol-Gel Technologies Ltd., Arcutis Biotherapeutics, Inc., Almirall S.A., Galderma S.A., Pfizer Inc.
+Added: The key competitive factors affecting the success of XYNGARI™ , if approved, will likely be its efficacy, safety, convenience of administration and delivery, price, and the availability of reimbursement from government and other third-party payors.
+Added: With respect to XYNGARI™ for the treatment of moderate-to-severe acne, if approved, we will primarily be competing with therapies such as other topical products, oral products, in-office procedures, such as laser surgery, off-label drugs, over the counter medication and homeopathic remedies.
+Added: With regards to XYNGARI™ for the treatment of mild-to-moderate psoriasis, if approved, we will face competition from topical therapies, oral therapies, systemic therapies, photo therapies and homeopathic treatments.
+Added: However, based on our clinical trials, we believe that XYNGARI™ has multiple competitive advantages over current treatment alternatives with significantly less adverse side effects.
+Added: Our main competition in these indications will be with products from Sun Pharmaceuticals Industries Ltd., Sol-Gel Technologies Ltd., Arcutis Biotherapeutics, Inc., Almirall S.A., Galderma S.A., Pfizer Inc.
See “ Business – Clinical Progress of our Lead Product Candidates ” for the results of our completed and ongoing clinical trials.
−Removed: While we are unaware of any potential similar competitive topical products to DMT310 for the treatment of acne and psoriasis, it is possible that such potentially similar competitive products are currently being developed.
+Added: While we are unaware of any potential similar competitive topical products to XYNGARI™ for the treatment of acne and psoriasis, it is possible that such potentially similar competitive products are currently being developed.
We are also in early stages of clinical development for DMT410 for treating various medical and aesthetic skin conditions and diseases, and if we obtain marketing approval in the future, we will compete with traditional therapies, such as topical products, oral products, in-office procedures, such as botulinum toxin injections, off-label drugs, over the counter medication and homeopathic remedies, as well as additional new entrants to the applicable markets.
1 unchanged sentence
Intellectual Property
−Removed: Our commercial success depends in part on our ability to obtain and maintain proprietary protection for DMT310, DMT400, DMT410 and any of our future product candidates, medical devices, methodologies, assays, drug development technologies, harvesting procedures, know-how;
+Added: Our commercial success depends in part on our ability to obtain and maintain proprietary protection for XYNGARI™, DMT400, DMT410 and any of our future product candidates, medical devices, methodologies, assays, drug development technologies, harvesting procedures, know-how;
to operate without infringing on or otherwise violating the proprietary rights of others;
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We currently have multiple patents and patent applications in our patent portfolio and continue to pursue and seek additional patent coverage of all our product candidates.
−Removed: Our DMT310 portfolio includes two families, one in-licensed and one owned by Dermata.
+Added: Our XYNGARI™ portfolio includes two families, one in-licensed and one owned by Dermata.
The in-licensed family includes patents and patent applications in-licensed from Villani, Inc.
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These in-licensed patents expired between 2022 and 2023 and did not receive any patent term adjustments or extensions.
−Removed: Based on the anticipated timing of any potential FDA approval of DMT310 for acne, the patents that expired in 2022 and 2023 are not material to our business, as we do not expect these patents to provide any protection for our product candidates and thus we have provided our licensor with a notice of abandonment for certain licensed patents.
−Removed: We expect our intellectual property portfolio to be protected by any potential NCE exclusivity for DMT310 and our other product candidates, the maintaining of our exclusive supply agreement for our raw material requirements, and our continued efforts to protect our proprietary information.
−Removed: We also have an additional Dermata owned family related to DMT310, with applications pending in the U.S., Australia, and Canada.
−Removed: This family refers to specific attributes of the DMT310 API and drug product as well as treatment related attributes for the treatment of acne based on the data received prior to its filing.
+Added: Based on the anticipated timing of any potential FDA approval of XYNGARI™ for acne, the patents that expired in 2022 and 2023 are not material to our business, as we do not expect these patents to provide any protection for our product candidates and thus we have provided our licensor with a notice of abandonment for certain licensed patents.
+Added: We expect our intellectual property portfolio to be protected by any potential NCE exclusivity for XYNGARI™ and our other product candidates, the maintaining of our exclusive supply agreement for our raw material requirements, and our continued efforts to protect our proprietary information.
+Added: We also have an additional Dermata owned family related to XYNGARI™, with a recent patent issuance in the U.S.
+Added: by the United States Patent and Trademark Office, entitled “Compositions and methods for the treatment of skin conditions” (U.S.
+Added: We also have applications pending in Australia, and Canada.
+Added: This family refers to specific attributes of the XYNGARI™ API and drug product as well as treatment related attributes for the treatment of acne based on the data received prior to its filing.
Patents in this patent family, if granted, are expected to expire in 2041, absent any patent term adjustments or extensions.
Our DMT410 portfolio includes two families owned by Dermata.
−Removed: The first family consists of one issued patent in Japan, a pending non-provisional U.S.
−Removed: patent application, and seven pending foreign patent applications in Australia, Canada, China, the European Patent Office, Japan, Hong Kong, and South Korea.
+Added: The first family consists of one issued patent in Japan, one allowed application in Australia, a pending non-provisional U.S.
+Added: patent application, and six pending foreign patent applications in Canada, China, the European Patent Office, Japan, Hong Kong, and South Korea.
These patents/patent applications relate to compositions for the treatment of skin diseases using our proprietary sponge powder in combination with multiple types of botulinum toxin for both medical and aesthetic skin conditions and diseases.
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Patents in this patent family, if granted, are expected to expire in 2039, absent any patent term adjustments or extensions.
−Removed: The second family consists of a pending applications in the U.S., Australia, Japan, and South Korea, covering compositions for the treatment of conditions by dermal fillers in combination with our proprietary sponge powder.
+Added: The second family consists of pending applications in the U.S., Australia, Japan, and South Korea, covering compositions for the treatment of conditions by dermal fillers in combination with our proprietary sponge powder.
Patents in this patent family, if granted, are expected to expire in 2040, absent any patent term adjustments or extensions.
The third family consists of a pending PCT application filed in January of 2024, covering the compositions for the treatment of conditions by vaccines in combination with our proprietary sponge powder.
−Removed: Although we believe our patent portfolio offers significant protection for DMT310, DMT410 and DMT400 and additional combination regimens, the protection offered by our patents may be, to some extent, more limited than the protection provided by patents which claim chemical structures which were previously unknown.
+Added: Although we believe our patent portfolio offers significant protection for XYNGARI™, DMT410 and DMT400 and additional combination regimens, the protection offered by our patents may be, to some extent, more limited than the protection provided by patents which claim chemical structures which were previously unknown.
Accordingly, other parties may compete with us, for example, by independently developing or obtaining competing topical formulations that design around our patent claims, but which may contain the same or similar active ingredients, or by seeking to invalidate our patents.
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The length of the patent term extension is related to the length of time the drug is under regulatory review.
−Removed: Patent extension cannot extend the remaining term of a patent beyond a total of 14 years from the date of product approval, and only one patent applicable to an approved drug may be extended.
+Added: Patent term extension cannot extend the remaining term of a patent beyond a total of 14 years from the date of product approval, and only one patent applicable to an approved drug may be extended.
Similar provisions are available in Europe and other jurisdictions to extend the term of a patent that covers an approved drug.
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In addition to patent protection, we also rely heavily on trade secrets, including unpatented know-how, technology innovation, technical specifications and assays and other proprietary information in attempting to develop and maintain our competitive advantage.
−Removed: We believe our ability to protect our unpatented know-how and trade secrets are as important if not more important than our patent portfolio due the complex nature and lack of expiration associated with such information.
+Added: We believe our ability to protect our unpatented know-how and trade secrets are as important if not more important than our patent portfolio due to the complex nature and lack of expiration associated with such information.
We seek trademark protection in the United States and in certain other jurisdictions where available and when we deem appropriate.
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Pursuant to the First License Amendment, we also agreed to make certain milestone payments to Villani, which rates were subsequently amended pursuant to the Second License Amendment, as discussed below.
−Removed: To date, the $750,000 milestone payment made in connection with the First License Amendment is the total amount paid to Villani in connection with the License.
On July 30, 2021, we entered into a Second Amendment to the License and Settlement Agreement (or, the Second License Amendment), whereby, for the settlement of certain disputes arising under the First License Amendment, we agreed to exchange the shares of Series 1c Preferred Stock owned by Villani for an increase of milestone payments and royalty rates due to Villani under the License Agreement.
The resulting royalty rates payable pursuant to the Second License Amendment are equal to single-digit percentages of net sales of Licensed Products and HMW Combination Products (as defined in the License Agreement), subject to certain adjustments as set forth in the Second License Amendment.
−Removed: Royalties are payable on a country-by-country and Licensed Product-by-Licensed Product basis, for the period of time from the effective date of the License Agreement until the later of (i) the expiration of the last to expire valid claim in such country (which is set to expire in 2023), (ii) the expiration of regulatory exclusivity for such Licensed Product in such country, and (iii) 15 years from the date of the first commercial sale of the Licensed Product in such country.
+Added: Royalties are payable on a country-by-country and Licensed Product-by-Licensed Product basis, for the period of time from the effective date of the License Agreement until the later of (i) the expiration of the last to expire valid claim in such country (which expired in 2023), (ii) the expiration of regulatory exclusivity for such Licensed Product in such country, and (iii) 15 years from the date of the first commercial sale of the Licensed Product in such country.
Pursuant to the Second License Amendment, if we sublicense the License, we are obligated to pay to Villani a sublicense fee of between 10% and 30% of Sublicense Revenues (as defined in the License Agreement).
Such future milestone payments due to Villani (all payable to Villani in cash or in equity, at the option of Villani) are in aggregate amounts of up to $3.5 million in development milestones and $37.0 million in sales milestones.
−Removed: We paid to Villani $1.0 million upon the closing of our initial public offering.
+Added: To date, we have paid Villani a total of $1,750,000 in connection with the License Agreement, inclusive of a $750,000 milestone payment and $1.0 million payment upon the closing of our initial public offering.
+Added: Clinical Trial Collaboration Agreement between the Company and Revance Therapeutics, Inc.
+Added: On January 17, 2025, the Company entered into a Clinical Trial Collaboration Agreement (Clinical Trial Agreement) with Revance Therapeutics, Inc.
+Added: (Revance), pursuant to which the Company and Revance intend to conduct a multi-center clinical trial (Trial) to evaluate the topical application of XYNGARI TM , the Company’s topical Spongilla powder (formerly referred to as DMT310), with DAXXIFY® (daxibotulinumtoxinA-lanm), Revance’s botulinum toxin type A.
+Added: Pursuant to the terms of the Clinical Trial Agreement, Revance has granted the Company a non-exclusive, worldwide, non-transferable, royalty-free license, with a right to sublicense (subject to limitations), to use certain Revance intellectual property, solely as necessary or useful for the Company to conduct the trial under the Clinical Trial Agreement.
+Added: The Company has granted Revance a similar license to use XYNGARI TM and other compound(s) under the Clinical Trial Agreement.
+Added: The Clinical Trial Agreement will terminate upon completion of the Trial, the delivery of the data resulting from the Trial and the completion of any statistical analyses of the data resulting from the Trial.
+Added: Either party may terminate the Clinical Trial Agreement upon a material breach by the other party that remains uncured following 30 days after the date of written notice of such breach.
+Added: In addition, either party may terminate the Clinical Trial Agreement immediately upon written notice if such party reasonably deems it necessary in order to protect the safety, health or welfare of subjects enrolled in the Trial.
+Added: The Company has agreed to sponsor, conduct, and fund the Phase 2a clinical trial, but no financial obligations or consideration is contemplated in the Clinical Trial Agreement.
Supply Agreement between the Company and Reka-Farm LLC
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Development of Drugs in the United States
+Added: Pre-Clinical Development
Products that we may develop or acquire in the future must be approved by the FDA before they may be legally marketed in the United States.
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Similar filings are required in other countries.
+Added: Laboratory and animal tests continue to be performed after an IND is approved.
Clinical Trials
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Chemistry, Controls and Manufacturing Development
−Removed: Concurrent with clinical trials, companies typically complete additional animal and laboratory studies, develop additional information about the chemistry and physical characteristics of the drug, and finalize a process for manufacturing the product in commercial quantities in accordance with FDA’s current Good Manufacturing Practices (“cGMP”) requirements.
+Added: Concurrent with clinical trials, companies typically complete additional animal and laboratory studies, develop additional information about the chemistry and physical characteristics of the drug, determine proposed commercial formulations for the drug, and finalize a process for manufacturing the product in commercial quantities in accordance with FDA’s current Good Manufacturing Practices (“cGMP”) requirements.
The manufacturing process must consistently produce quality batches of the drug, and, among other things, the manufacturer must develop methods for testing the identity, strength, quality and purity of the final drug.
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Most currently approved topical dermatology products are reviewed solely by the FDA’s Office of Dermatology and Dental Products and follow a standard approval pathway.
−Removed: However, due to our lead product candidate, DMT310, being derived from a natural source, it will be reviewed by the FDA Office of Dermatology and Dental Products with input from the FDA Botanical Review Division.
+Added: However, due to our lead product candidate, XYNGARI™ , being derived from a natural source, it will be reviewed by the FDA Office of Dermatology and Dental Products with input from the FDA Botanical Review Division.
While Spongilla is not a botanical, the FDA has allowed us to reference the Botanical Guidance for raw material quality control and batch to batch consistency through development and into commercialization.
−Removed: We believe our ability to reference the Botanical Guidance and receive input from the Botanical Review Division on DMT310 provides us with key advantages in DMT310’s regulatory pathway to approval, if achieved.
−Removed: These advantages include being able to move into human clinical studies upon the FDA’s acknowledged receipt of our IND letter and subsequent study may proceed, saving us substantial financial resources to achieve human clinical data.
−Removed: Additionally, while we believe that our sponge contains multiple active chemical compounds, based on our regulatory analysis of the feedback from the FDA and the Botanical Guidance, we believe we are only required to provide identifiable and quantifiable active components to show quality control and batch to batch consistency.
−Removed: We believe this will make it more difficult for a potential competitor to copy DMT310 and produce a similar product due to their inability to know every component of our product candidate.
+Added: We believe our ability to reference the Botanical Guidance and receive input from the Botanical Review Division on XYNGARI™ provides us with key advantages in XYNGARI’s™ regulatory pathway to approval, if achieved.
+Added: These advantages included being able to move into human clinical studies upon the FDA’s acknowledged receipt of our IND letter and that our subsequent study may proceed without having to first complete the typical nonclinical studies often required on many dermatology products, saving us substantial financial resources to achieve human clinical data.
+Added: Additionally, while we believe that our source sponge material contains multiple active chemical compounds, based on our regulatory analysis of the feedback from the FDA and the Botanical Guidance, we believe we are only required to provide identifiable and quantifiable active components to show quality control and batch to batch consistency.
+Added: We believe this will make it more difficult for a potential competitor to copy XYNGARI™ and produce a similar product due to their inability to know every component of our product candidate.
Thus, we believe a competitor with a similar product or product candidate would have to conduct all of the manufacturing, development, and regulatory steps we must complete for approval.
−Removed: However, there can be no assurance that we successfully navigate the development of DMT310 or that DMT310 will receive FDA approval.
+Added: However, there can be no assurance that we successfully navigate the development of XYNGARI™ or that XYNGARI™ will receive FDA approval.
Special Regulatory Procedures
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Controlled Substances Act and the Controlled Substances Import and Export Act.
−Removed: Schedule I controlled substances are pharmaceutical products subject to specific regulations under the CSA, that establishes, among other things, certain registration, manufacturing quotas, security, recordkeeping, reporting, import, export and other requirements administered by the DEA.
−Removed: All parties responsible for the manufacturing, distribution and testing the drug in clinical studies must apply for and obtain a license from the DEA before they are permitted to perform these activities.
−Removed: Furthermore, these parties must have the security, control, recordkeeping, reporting and inventory mechanisms required by the DEA to prevent drug loss and diversion.
−Removed: All licensed facilities are required to renew their registrations annually if they intend to continue to work with our drug.
−Removed: The DEA conducts periodic inspections of certain registered establishments that handle controlled substances.
−Removed: Individual states have also established controlled substance laws and regulations.
−Removed: Though state-controlled substances laws often mirror federal law because the states are separate jurisdictions, they may separately schedule drugs, as well.
−Removed: While some states automatically schedule a drug based on federal action, other states schedule drugs through rulemaking or a legislative action.
−Removed: We and our manufacturing vendors and clinical sites must also obtain separate state registrations, permits or licenses in order to be able to obtain, handle, and distribute controlled substances for clinical trials or commercial sale, and failure to meet applicable regulatory requirements could lead to enforcement and sanctions by the states in addition to those from the DEA or otherwise arising under federal law.
Third-Party Payer Coverage and Reimbursement
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The United States Congress and state legislatures may, from time to time, propose and adopt initiatives aimed at cost containment, which could impact our ability to sell our product candidates profitably.
−Removed: For example, the two-year spending law signed by the President of United States on February 9, 2018 includes a provision raising the manufacturer discount to 70% in 2019 in the Medicare Part D coverage gap, also known as the “donut hole.” Under prior law, manufacturers were required to provide a 50% discount on prescription drugs purchased in the donut hole.
−Removed: Manufacturers of branded drugs will face much higher liabilities from donut hole payments beginning in 2019, estimated at multiple billions of dollars for some of the largest companies.
+Added: For example, under the Inflation Reduction Act, CMS is authorized to negotiate the prices that Medicare pays for certain drugs.
+Added: The first round of negotiations concluded in 2024 and CMS has released a list of drugs whose prices will be negotiated in 2025.
The cost of pharmaceuticals continues to generate substantial governmental and third-party payer interest.
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Our results of operations could be adversely affected by current and future healthcare reforms.
+Added: Patent Term Restoration and Marketing Exclusivity
+Added: Depending upon the timing, duration and specifics of FDA approval of our future product candidates, some of our U.S.
+Added: patents may be eligible for limited patent term extension under the Drug Price Competition and Patent Term Restoration Act of 1984, commonly referred to as the Hatch-Waxman Amendments.
+Added: The Hatch-Waxman Amendments permit restoration of the patent term of up to five years as compensation for patent term lost during the FDA regulatory review process.
+Added: Patent-term restoration, however, cannot extend the remaining term of a patent beyond a total of 14 years from the product’s approval date and only those claims covering such approved drug product, a method for using it or a method for manufacturing it may be extended.
+Added: The patent-term restoration period is generally one-half the time between the effective date of an IND and the submission date of an NDA plus the time between the submission date of an NDA and the approval of that application, except that the review period is reduced by any time during which the applicant failed to exercise due diligence.
+Added: Only one patent applicable to an approved drug is eligible for the extension and the application for the extension must be submitted prior to the expiration of the patent.
+Added: The USPTO, in consultation with the FDA, reviews and approves the application for any patent term extension or restoration.
+Added: In the future, we may apply for restoration of patent term for our currently owned or licensed patents to add patent life beyond its current expiration date, depending on the expected length of the clinical trials and other factors involved in the filing of the relevant NDA.
+Added: Marketing exclusivity provisions under the FD&C Act also can delay the submission or the approval of certain applications.
+Added: The FD&C Act provides a five-year period of non-patent marketing exclusivity within the United States to the first applicant to gain approval of an NDA for a new chemical entity.
+Added: A drug is a new chemical entity if the FDA has not previously approved any other new drug containing the same active moiety, which is the molecule or ion responsible for the action of the drug substance.
+Added: During the exclusivity period, the FDA may not accept for review an abbreviated new drug application, or ANDA, or a 505(b)(2) NDA submitted by another company for another version of such drug where the applicant does not own or have a legal right of reference to all the data required for approval.
+Added: However, an application may be submitted after four years if it contains a certification of patent invalidity or non-infringement.
+Added: The FD&C Act also provides three years of marketing exclusivity for an NDA, 505(b)(2) NDA or supplement to an existing NDA if new clinical investigations, other than bioavailability studies, that were conducted or sponsored by the applicant are deemed by the FDA to be essential to the approval of the application, for example, new indications, dosages or strengths of an existing drug.
+Added: This three-year exclusivity covers only the conditions of use associated with the new clinical investigations and does not prohibit the FDA from approving ANDAs for drugs containing the original active agent.
+Added: Five-year and three-year exclusivity will not delay the submission or approval of a full NDA.
+Added: However, an applicant submitting a full NDA would be required to conduct or obtain a right of reference to all of the preclinical studies and adequate and well-controlled clinical trials necessary to demonstrate safety and effectiveness.
Some third-party payers also require pre-approval of coverage for new or innovative devices or drug therapies before they reimburse healthcare providers that use such therapies.
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Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.