The goal of this clinical trial is to test the effects of DaxibotulinumtoxinA-Lanm (Daxxify) in patients with benign essential blepharospasms (BEB) and hemifacial spasms (HFS). The main questions to answer:
1. Is there clinically significant difference (measured by Jankovic Rating Scale (JRS) score from base to peak efficacy) for patients with BEB and HFS treated with Daxxify?
2. What percentage of patients achieve a clinical response?
Participants historically treated with Botox for either BEB or HFS will be crossed over to Daxxify treatment in order to serve as their own control and examine the efficacy of Daxxify.

Start Date11 Feb 2025

Sponsor / Collaborator

Montefiore Medical Center

[+1]

NCT06411002

/ CompletedPhase 2

A Phase 2a Study to Evaluate the Effects of DaxibotulinumtoxinA for Injection on the Treatment of Dynamic Forehead Lines and Glabellar Lines

This is a Phase 2a open-label, single-arm study to evaluate the effects of DaxibotulinumtoxinA-lanm (DAXI) for Injection on the treatment of dynamic forehead lines (FHL) and glabellar lines (GL).
Approximately 40 subjects (18 years of age and above) with moderate to severe GL and FHL (all assessed at maximum contraction) will be screened for eligibility with the goal of enrolling and treating 30 subjects to receive DAXI for injection after providing informed consent.
The primary objective of this study is to determine the efficacy and safety of the combined treatment of two upper facial regions with DAXI for injection.

Start Date08 Apr 2024

Sponsor / Collaborator

Revance Therapeutics, Inc.

NCT06225492

/ CompletedPhase 4IIT

Use of DaxibotulinimtoxinA Injection for Platysma Bands of the Neck

This study seeks to evaluate the effectiveness and duration of action of DaxibotulinumtoxinA for neck rejuvenation through treatment of platysmal bands. This study will consist of one treatment visit with subjects being randomized to receiving 15 or 20 units of DaxibotulinumtoxinA per platysmal band. Subjects will return for 5 follow-up visits at 8, 12, 16, 20, and 24 weeks for evaluation.

Start Date01 Jan 2024

Sponsor / Collaborator

Main Line Center for Laser Surgery

100 Clinical Results associated with Daxibotulinumtoixn A-LANM

100 Translational Medicine associated with Daxibotulinumtoixn A-LANM

100 Patents (Medical) associated with Daxibotulinumtoixn A-LANM

Literatures (Medical) associated with Daxibotulinumtoixn A-LANM

01 Feb 2026·JOURNAL OF PHARMACEUTICAL SCIENCES

Excipient substitution in botulinum toxin type A formulations: Insights from multi-scale in silico modelling

Article

Author: Wu, Woffles T L ; Webb, William Richard ; Rao, Parinitha ; Joseph, John H ; Rahman, Eqram ; Michon, Alain ; Carruthers, Jean D A

Botulinum neurotoxin type A (BoNT/A) formulations differ mainly in excipients, which determine stability, aggregation, and diffusion. Using multi-scale in silico modelling (AesthetiSIM™), we evaluated excipient substitution across six marketed products. The 150 kDa neurotoxin backbone showed lower RMSD (3.6 ± 0.4 Å) than the 900 kDa complex (4.8 ± 0.6 Å, p = 0.019). Among excipients, trehalose formed 23.1 ± 2.7 hydrogen bonds and -106 ± 6 kcal/mol interaction energy, outperforming sucrose (19.8 ± 2.5 bonds, -93 ± 5 kcal/mol) and lactose (9.6 ± 1.8 bonds, -74 ± 5 kcal/mol). Trehalose combined with HSA yielded synergistic stabilization with 30.1 ± 3.2 bonds, interaction energy of -112 ± 7 kcal/mol, and reduced RMSD to 3.1 ± 0.3 Å. Coarse-grained simulations showed the lowest aggregation with trehalose-HSA (mean cluster size 2.4 ± 0.4 molecules), compared with sucrose (3.7 ± 0.7) and lactose (5.4 ± 1.0, p < 0.001). Finite element modelling predicted diffusion radii of 1.25 ± 0.05 mm for trehalose-HSA versus 1.36 ± 0.06 mm with sucrose (p = 0.014). Reformulated PRABO and LETYBO with trehalose-HSA achieved the longest durations (186 ± 8 and 184 ± 9 days), followed by INCO (176 ± 7), ONA (170 ± 8), DAXI (167 ± 10), and ABO (160 ± 7). Reconstitution with 0.5 mL per 100 units minimized spread (1.22 ± 0.04 mm) and maximized persistence (188 ± 9 days, p < 0.01 vs 2.5 mL). Across molecular, mesoscopic, and tissue levels, trehalose-HSA consistently provided superior stability, aggregation resistance, and duration, offering a rational basis for next-generation BoNT/A formulations.

01 Feb 2026·INTERNATIONAL JOURNAL OF PHARMACEUTICS

Corrigendum to “A novel peptide excipient stabilizes DaxibotulinumtoxinA” [Int. J. Pharm. 685 (2025) 126238]

Author: Zhou, Shaoqiu ; Gallagher, Conor J ; Reza Malmirchegini, G

01 Jan 2026·TOXICON

Computational model-informed comparative evaluation of botulinum toxin a formulations: A 20-year simulation of onset, diffusion, duration, and immunogenicity

Article

Author: Rao, Parinitha ; Joseph, John H ; Rahman, Eqram ; Ahmed, Munim ; Carruthers, Jean DA ; Wu, Woffles Tl ; Webb, William Richard ; Michon, Alain

Comparative evaluation of botulinum neurotoxin type A (BoNT/A) formulations is limited by short clinical trials and lack of long-term safety data. This study applied a validated multiscale computational model (AesthetiSIM™) to simulate 20 years of repeated treatment with eight BoNT/A formulations, integrating receptor binding kinetics, tissue diffusion, pharmacodynamic response, and HLA-weighted immunogenicity. Model parameters were calibrated against published biochemical, imaging, and randomized clinical trial data, and uncertainty was quantified through 10,000 Monte Carlo iterations. Each virtual patient underwent standardized five-site glabellar injections with clinically equivalent doses. LetibotulinumtoxinA and PrabotulinumtoxinA predicted the most balanced profiles, combining high efficacy (mean peak strain reduction 72 % and 68 %, respectively), rapid onset (2.7-3.1 days), and minimal predicted neutralizing antibody incidence over 20 years (0.4-0.6 %). DaxibotulinumtoxinA showed the longest modelled duration of effect (median 142 days), whereas AbobotulinumtoxinA and Relatox exhibited broader diffusion and higher immunogenicity risk. Overall ranking stability remained high (ρ = 0.92) across all uncertainty scenarios. These simulations align closely with available empirical data and suggest that formulation-specific differences in protein structure, diffusion behaviour, and antigenicity may contribute to observed clinical variability. Model-informed comparative analysis can complement real-world and prospective studies to optimize product selection and dosing strategies in aesthetic and therapeutic applications.

100

News (Medical) associated with Daxibotulinumtoixn A-LANM

06 Oct 2025

·news.abbvie.com

AbbVie Announces Positive Topline Results from Phase 2 ELATE Trial Evaluating OnabotulinumtoxinA (BOTOX®) for the Treatment of Upper Limb Essential Tremor

OnabotulinumtoxinA (BOTOX®) met the primary endpoint in the Phase 2 trial, demonstrating a statistically significant improvement from baseline in the Tremor Disability Scale-Revised (TREDS-R) total unilateral score compared to placebo.1 The trial also met all six secondary endpoints.2 Results from safety analyses were generally consistent with the well-established safety profile of onabotulinumtoxinA.1 NORTH CHICAGO, Ill., Oct. 6, 2025 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced positive topline results from the Phase 2 ELATE trial evaluating the safety and efficacy of onabotulinumtoxinA (BOTOX®) compared to placebo for the treatment of upper limb essential tremor. The study met its primary endpoint, demonstrating statistically significant improvements in the Tremor Disability Scale-Revised (TREDS-R) of onabotulinumtoxinA compared to placebo at week 18. Specifically, the onabotulinumtoxinA group showed a greater reduction in TREDS-R total unilateral score compared to placebo, with scores of -2.61 versus -1.61, (p=0.029).1 The study also met all six secondary endpoints.2 "Essential tremor is a progressive neurological condition that affects millions worldwide and often results in unsatisfactory outcomes with current treatments," said Daniel Mikol, M.D., Ph.D., vice president, neuroscience development, AbbVie. "No new pharmacological treatments have been approved in the U.S. for essential tremor for more than 30 years. These results represent a significant advance and demonstrate further proof of mechanism for a neurotoxin as a potential treatment option to help patients and healthcare providers manage this challenging condition." Safety results were generally consistent with the well-established safety profile of onabotulinumtoxinA. Muscular weakness was the most common adverse event, with reported rates of 24.5% in the onabotulinumtoxinA group versus 2.3% in the placebo group. Instances were localized and transient and most were classified as mild or moderate in nature.1 Results from the study will be presented at the International Congress of Parkinson's Disease and Movement Disorders® on October 8, 2025. The use of BOTOX® for essential tremor is not approved by the U.S. Food and Drug Administration (FDA) or any other global regulatory authority and its safety and efficacy have not been evaluated by regulatory authorities. About the ELATE Study The ELATE trial was a Phase 2 multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the safety and efficacy of onabotulinumtoxinA for the treatment of upper limb essential tremor in adults. The primary efficacy measure was the change in the Tremor Disability Scale-Revised (TREDS-R) total score across seven unilateral items from baseline across weeks 15, 18 and 21. Secondary outcome measures included activity of daily living assessment, various tremor assessment scales and global impression of severity scores. More information on the ELATE trial can be found on www.clinicaltrials.gov. About Essential Tremor Essential tremor is the most common movement disorder, impacting approximately 25–60 million individuals worldwide.3 This condition complicates physical activities due to uncontrollable and involuntary action tremors and furthermore often results in depression, anxiety and social embarrassment, thereby affecting overall quality of life.4 Current treatment options are limited in both efficacy and tolerability often leaving patients with few viable options. About BOTOX® (onabotulinumtoxinA) BOTOX® was first approved by the FDA in 1989 for two rare eye muscle disorders – blepharospasm and strabismus in adults. Today, BOTOX® is FDA-approved for multiple therapeutic indications, including chronic migraine, overactive bladder, leakage of urine (incontinence) due to detrusor overactivity associated with a neurologic condition in adults and in pediatric patients five years of age and older, cervical dystonia, adult and pediatric spasticity, and severe underarm sweating (axillary hyperhidrosis). BOTOX® is not FDA-approved for essential tremor. BOTOX® (onabotulinumtoxinA) Important Information U.S. Indications BOTOX® (onabotulinumtoxinA) is a prescription medicine that is injected into muscles and used: To treat overactive bladder symptoms such as a strong need to urinate with leaking or wetting accidents (urge urinary incontinence), a strong need to urinate right away (urgency), and urinating often (frequency) in adults 18 years and older when another type of medicine (anticholinergic) does not work well enough or cannot be taken To treat leakage of urine (incontinence) in adults 18 years and older with overactive bladder due to a neurologic disease when another type of medicine (anticholinergic) does not work well enough or cannot be taken To treat overactive bladder due to a neurologic disease in children 5 years of age and older when another type of medicine (anticholinergic) does not work well enough or cannot be taken To prevent headaches in adults with chronic migraine who have 15 or more days each month with headache lasting 4 or more hours each day in people 18 years and older To treat increased muscle stiffness in people 2 years of age and older with spasticity To treat the abnormal head position and neck pain that happens with cervical dystonia (CD) in people 16 years and older To treat certain types of eye muscle problems (strabismus) or abnormal spasm of the eyelids (blepharospasm) in people 12 years of age and older BOTOX is also injected into the skin to treat the symptoms of severe underarm sweating (severe primary axillary hyperhidrosis) when medicines used on the skin (topical) do not work well enough in people 18 years and older. It is not known whether BOTOX is safe and effective to prevent headaches in patients with migraine who have 14 or fewer headache days each month (episodic migraine). BOTOX has not been shown to help people perform task-specific functions with their upper limbs or increase movement in joints that are permanently fixed in position by stiff muscles. It is not known whether BOTOX is safe and effective for severe sweating anywhere other than your armpits. U.S. IMPORTANT SAFETY INFORMATION BOTOX may cause serious side effects that can be life threatening. Get medical help right away if you have any of these problems any time (hours to weeks) after injection of BOTOX: Problems swallowing, speaking, or breathing, due to weakening of associated muscles, can be severe and result in loss of life. You are at the highest risk if these problems are preexisting before injection. Swallowing problems may last for several months. Spread of toxin effects. The effect of botulinum toxin may affect areas away from the injection site and cause serious symptoms, including loss of strength and all-over muscle weakness; double vision; blurred vision; drooping eyelids; hoarseness or change or loss of voice; trouble saying words clearly; loss of bladder control; trouble breathing; and trouble swallowing. There has not been a confirmed serious case of spread of toxin effect away from the injection site when BOTOX has been used at the recommended dose to treat chronic migraine, severe underarm sweating, blepharospasm, or strabismus. BOTOX may cause loss of strength or general muscle weakness, vision problems, or dizziness within hours to weeks of receiving BOTOX. If this happens, do not drive a car, operate machinery, or do other dangerous activities. Do not receive BOTOX if you are allergic to any of the ingredients in BOTOX (see Medication Guide for ingredients); had an allergic reaction to any other botulinum toxin product such as Myobloc® (rimabotulinumtoxinB), Dysport® (abobotulinumtoxinA), Xeomin® (incobotulinumtoxinA), Jeuveau® (prabotulinumtoxinA-xvfs), Daxxify® (daxibotulinumtoxinA-lanm), or Letybo® (letibotulinumtoxinA-wlbg) (this may not be a complete list of all botulinum toxin products); have a skin infection at the planned injection site. Do not receive BOTOX for the treatment of urinary incontinence if you have a urinary tract infection (UTI) or cannot empty your bladder on your own and are not routinely catheterizing. Due to the risk of urinary retention (difficulty fully emptying the bladder), only patients who are willing and able to initiate catheterization posttreatment, if required, should be considered for treatment. Patients treated for overactive bladder: In clinical trials, 36 of the 552 patients had to self-catheterize for urinary retention following treatment with BOTOX compared to 2 of the 542 treated with placebo. The median duration of postinjection catheterization for these patients treated with BOTOX 100 Units (n = 36) was 63 days (minimum 1 day to maximum 214 days), as compared to a median duration of 11 days (minimum 3 days to maximum 18 days) for patients receiving placebo (n = 2). Patients with diabetes mellitus treated with BOTOX were more likely to develop urinary retention than nondiabetics. Adult patients treated for overactive bladder due to a neurologic disease: In clinical trials, 30.6% of adult patients (33/108) who were not using clean intermittent catheterization (CIC) prior to injection required catheterization for urinary retention following treatment with BOTOX 200 Units, as compared to 6.7% of patients (7/104) treated with placebo. The median duration of postinjection catheterization for these patients treated with BOTOX 200 Units (n = 33) was 289 days (minimum 1 day to maximum 530 days), as compared to a median duration of 358 days (minimum 2 days to maximum 379 days) for patients receiving placebo (n = 7). Among adult patients not using CIC at baseline, those with multiple sclerosis were more likely to require CIC postinjection than those with spinal cord injury. The dose of BOTOX is not the same as, or comparable to, another botulinum toxin product. Serious and/or immediate allergic reactions have been reported, including itching; rash; red, itchy welts; wheezing; asthma symptoms; dizziness; or feeling faint. Get medical help right away if you experience symptoms; further injection of BOTOX should be discontinued. Tell your doctor about all your muscle or nerve conditions, such as ALS or Lou Gehrig's disease, myasthenia gravis, or Lambert-Eaton syndrome, as you may be at increased risk of serious side effects, including difficulty swallowing and difficulty breathing from typical doses of BOTOX. Tell your doctor if you have any breathing-related problems. Your doctor may monitor you for breathing problems during treatment with BOTOX for spasticity or for detrusor overactivity associated with a neurologic condition. The risk of developing lung disease in patients with reduced lung function is increased in patients receiving BOTOX. Cornea problems have been reported. Cornea (surface of the eye) problems have been reported in some people receiving BOTOX for their blepharospasm, especially in people with certain nerve disorders. BOTOX may cause the eyelids to blink less, which could lead to the surface of the eye being exposed to air more than is usual. Tell your doctor if you experience any problems with your eyes while receiving BOTOX. Your doctor may treat your eyes with drops, ointments, contact lenses, or with an eye patch. Bleeding behind the eye has been reported. Bleeding behind the eyeball has been reported in some people receiving BOTOX for their strabismus. Tell your doctor if you notice any new visual problems while receiving BOTOX. Bronchitis and upper respiratory tract infections (common colds) have been reported. Bronchitis was reported more frequently in adults receiving BOTOX for upper limb spasticity. Upper respiratory infections were also reported more frequently in adults with prior breathing-related problems with spasticity. In pediatric patients treated with BOTOX for upper limb spasticity, upper respiratory tract infections were reported more frequently. In pediatric patients treated with BOTOX for lower limb spasticity, upper respiratory tract infections were not reported more frequently than placebo. Autonomic dysreflexia in patients treated for overactive bladder due to a neurologic disease. Autonomic dysreflexia associated with intradetrusor injections of BOTOX could occur in patients treated for detrusor overactivity associated with a neurologic condition and may require prompt medical therapy. In clinical trials, the incidence of autonomic dysreflexia was greater in adult patients treated with BOTOX 200 Units compared with placebo (1.5% versus 0.4%, respectively). Tell your doctor about all your medical conditions, including if you have or have had bleeding problems; have plans to have surgery; had surgery on your face; have weakness of forehead muscles, trouble raising your eyebrows, drooping eyelids, and any other abnormal facial change; have symptoms of a UTI and are being treated for urinary incontinence (symptoms of a UTI may include pain or burning with urination, frequent urination, or fever); have problems emptying your bladder on your own and are being treated for urinary incontinence; are pregnant or plan to become pregnant (it is not known if BOTOX can harm your unborn baby); are breastfeeding or plan to (it is not known if BOTOX passes into breast milk). Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Using BOTOX with certain other medicines may cause serious side effects. Do not start any new medicines until you have told your doctor that you have received BOTOX in the past. Tell your doctor if you received any other botulinum toxin product in the last 4 months; have received injections of botulinum toxin such as Myobloc®, Dysport®, Xeomin®, Jeuveau®, Daxxify®, or Letybo® in the past (this may not be a complete list of all botulinum toxin products; tell your doctor exactly which product you received); have recently received an antibiotic by injection; take muscle relaxants; take an allergy or cold medicine; take a sleep medicine; take aspirin-like products or blood thinners. Other side effects of BOTOX include dry mouth; discomfort or pain at the injection site; tiredness; headache; neck pain; eye problems such as double vision, blurred vision, decreased eyesight, drooping eyelids, swelling of your eyelids, and dry eyes; drooping eyebrows; and upper respiratory tract infection. In adults being treated for urinary incontinence, other side effects include UTI and painful urination. In children being treated for urinary incontinence, other side effects include UTI; bacteria, white blood cells, and blood in the urine. In patients being treated for urinary incontinence, another side effect includes the inability to empty your bladder on your own. If you have difficulty fully emptying your bladder on your own after receiving BOTOX, you may need to use disposable self-catheters to empty your bladder up to a few times each day until your bladder is able to start emptying again. For more information, refer to the Medication Guide or talk with your doctor. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088. If you are having difficulty paying for your medicine, AbbVie may be able to help. Visit AbbVie.com/PatientAccessSupport to learn more. Please see BOTOX® full Product Information, including Boxed Warning and Medication Guide. Globally, prescribing information varies; refer to the individual country product label for complete information. About AbbVie AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology, neuroscience and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X (formerly Twitter) and YouTube. Forward-Looking Statements Some statements in this news release are, or may be considered, forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words "believe," "expect," "anticipate," "project" and similar expressions and uses of future or conditional verbs, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those expressed or implied in the forward-looking statements. Such risks and uncertainties include, but are not limited to, challenges to intellectual property, competition from other products, difficulties inherent in the research and development process, adverse litigation or government action, changes to laws and regulations applicable to our industry, the impact of global macroeconomic factors, such as economic downturns or uncertainty, international conflict, trade disputes and tariffs, and other uncertainties and risks associated with global business operations. Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's operations is set forth in Item 1A, "Risk Factors," of AbbVie's 2024 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission, as updated by its Quarterly Reports on Form 10-Q and in other documents that AbbVie subsequently files with the Securities and Exchange Commission that update, supplement or supersede such information. AbbVie undertakes no obligation, and specifically declines, to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law. AbbVie Media: Liz Tang, Ph.D. liz.tang@abbvie.com Investors: Liz Shea liz.shea@abbvie.com References: SOURCE AbbVie

Clinical ResultPhase 2Drug Approval

13 Aug 2025

·ir.dermatarx.com

Dermata Therapeutics Provides Corporate Update and Reports Second Quarter 2025 Financial Results

- Dermata announced additional positive data from its XYNGARI™ Phase 3 Spongilla Treatment of Acne Research (STAR-1) clinical trial- - Raised $8.8 million in gross proceeds from a private placement and warrant inducement financings during the first half of 2025 - SAN DIEGO, CALIFORNIA / ACCESS Newswire / August 13, 2025 / Dermata Therapeutics, Inc. (Nasdaq:DRMA; DRMAW) ("Dermata," or the "Company"), a late-stage biotechnology company focused on the treatment of medical skin diseases and aesthetic applications, today highlighted recent corporate progress and reported financial results for the second quarter ended June 30, 2025. "We are very excited to have received the full data set from our Phase 3 STAR-1 trial of XYNGARI™ showing that XYNGARI™ achieved statistically significant results for its three co-primary endpoints at weeks 4 and 12," commented Gerry Proehl, Dermata's Chairman, President, and Chief Executive Officer. "We believe these data show that not only does XYNGARI™ work after the FDA required 12-week primary endpoint, but it also works as early as week four, which was the earliest measured timepoint. We strongly believe if consumers are able to gain access to our Spongilla technology acne patients will experience the many unique benefits our product candidate can offer, and our team continues to work hard to make this happen," concluded Mr. Proehl. Corporate Highlights Announced positive topline data from its XYNGARI™ Phase 3 STAR-1 clinical trial in moderate-to-severe acne. In March 2025, Dermata announced that its STAR-1 study met all three primary endpoints by producing highly statistically significant results versus placebo at the end of study. In April 2025, Dermata also announced that XYNGARI™ achieved statistically significant separation from placebo after just 4 weeks, or only four treatments. STAR-1 is the first of two Phase 3 clinical trials, the second of which would be followed by a long-term extension study, which the Company would need to complete prior to filing a new drug application with the U.S. Food and Drug Administration. Announced positive topline data from its XYNGARI™ Phase 3 STAR-1 clinical trial in moderate-to-severe acne. In March 2025, Dermata announced that its STAR-1 study met all three primary endpoints by producing highly statistically significant results versus placebo at the end of study. In April 2025, Dermata also announced that XYNGARI™ achieved statistically significant separation from placebo after just 4 weeks, or only four treatments. STAR-1 is the first of two Phase 3 clinical trials, the second of which would be followed by a long-term extension study, which the Company would need to complete prior to filing a new drug application with the U.S. Food and Drug Administration. Raised $8.8 million in gross proceeds during the first half of 2025. The funds raised during the first half of 2025 are expected to fund its operations into the second quarter of 2026. Raised $8.8 million in gross proceeds during the first half of 2025. The funds raised during the first half of 2025 are expected to fund its operations into the second quarter of 2026. Anticipated Upcoming Milestones Second XYNGARI™ Phase 3 STAR-2 clinical trial in moderate-to-severe acne. With positive results from the STAR-1 trial, the Company initiated additional manufacturing and is evaluating next steps with respect to the XYNGARI™ Phase 3 STAR-2 clinical trial. The STAR-2 trial would be followed by a 9-month extension study. Second XYNGARI™ Phase 3 STAR-2 clinical trial in moderate-to-severe acne. With positive results from the STAR-1 trial, the Company initiated additional manufacturing and is evaluating next steps with respect to the XYNGARI™ Phase 3 STAR-2 clinical trial. The STAR-2 trial would be followed by a 9-month extension study. DMT410 Phase 2a clinical study with Revance. The Company and Revance continue to collaborate on the final study design and start-up procedures to prepare for the Phase 2a clinical study of XYNGARI™ with DAXXIFY® for the topical treatment of axillary hyperhidrosis. DMT410 Phase 2a clinical study with Revance. The Company and Revance continue to collaborate on the final study design and start-up procedures to prepare for the Phase 2a clinical study of XYNGARI™ with DAXXIFY® for the topical treatment of axillary hyperhidrosis. Second Quarter 2025 Financial Results As of June 30, 2025, the Company had $6.5 million in cash and cash equivalents, compared to $3.2 million as of December 31, 2024. The $3.3 million increase in cash and cash equivalents for the six months ended June 30, 2025, resulted from approximately $7.9 million of net financing proceeds offset by $4.6 million of cash used in operations. The Company expects its current cash resources to be sufficient to fund operations into the second quarter of 2026. Research and development expenses were $0.6 million for the quarter ended June 30, 2025, compared to $2.0 million for the quarter ended June 30, 2024. The $1.4 million decrease in research and development expenses was primarily the result of $1.6 million of decreased clinical expenses from the XYNGARI™ STAR-1 acne study, which topline data results were announced in March 2025, partially offset by $0.1 million of increased chemistry, manufacturing, and controls, or CMC, expenses and $0.1 million of increased personnel costs. General and administrative expenses were $1.2 million for the quarter ended June 30, 2025, compared to $0.9 million for the same period in 2024. The $0.3 million increase in general and administrative expenses resulted from $0.2 million of increased public company compliance costs as well as $0.1 million of increased personnel costs. About Dermata Therapeutics Dermata Therapeutics is a late-stage biotechnology company focusing on the treatment of medical skin diseases and aesthetic applications. The Company's lead product candidate, XYNGARI™, recently achieved positive data in its first Phase 3 clinical trial and is the Company's first product candidate being developed from its Spongilla technology platform. XYNGARI™ is a once-weekly, topical product candidate derived from a naturally sourced freshwater sponge with multiple unique mechanisms of action. In addition to acne, XYNGARI™ has been studied for the treatment of psoriasis and rosacea. The Company's second product candidate, DMT410, uses its XYNGARI™ product candidate as a new method for needle-free intradermal delivery of botulinum toxin for the treatment of multiple aesthetic applications and medical skin diseases like hyperhidrosis, acne, and rosacea. Dermata is headquartered in San Diego, California. For more information, please visit http://www.dermatarx.com/. Forward-Looking Statements Statements in this press release that are not strictly historical in nature are forward-looking statements. These statements are based on the Company's current beliefs and expectations and new risks may emerge from time to time. Forward-looking statements are subject to known and unknown risks, uncertainties, assumptions, and other factors including, but are not limited to, statements related to: expectations with regard to the timing of meetings and/or responses from submissions with regulatory bodies; expectations with regard to the timing of submission of an NDA; the uncertainties inherent in clinical trials including enrolling an adequate number of patients on time or to be completed on schedule, if at all; timing and ability initiate a clinical trial and to generate clinical data; expectations with regard to the nature of any clinical data; expectations with regard to any potential partnership opportunities for any of the Company's product candidates; the Company's expectations with regard to current cash and cash equivalents and the amount of time it will fund operations; the success, cost, and timing of its product candidates XYNGARI™ and DMT410 development activities and ongoing and planned clinical trials; and whether the results of any ongoing or planned clinical trials of XYNGARI™ or DMT410 will lead to future product development. These statements are only predictions based on current information and expectations and involve a number of risks and uncertainties. Actual events or results may differ materially from those projected in any of such statements due to various factors, including the risks and uncertainties inherent in drug development, approval, and commercialization, and the fact that past results of clinical trials may not be indicative of future trial results. For a discussion of these and other factors, please refer to Dermata's filings with the Securities and Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. This caution is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. All forward-looking statements are qualified in their entirety by this cautionary statement and Dermata undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof, except as required by law. DERMATA THERAPEUTICS, INC. Balance Sheets June 30, 2025 December 31, 2024 (unaudited) $ 6,481 $ 3,162 $ 160 372 $ 6,641 3,534 $ 414 808 $ 612 1,165 $ 1,026 1,973 $ 5,614 1,561 $ 6,640 $ 3,534 DERMATA THERAPEUTICS, INC. Statements of Operations (unaudited) Quarter Ended June 30, Six Months Ended June 30, 2025 2024 2025 2024 $ 618 $ 2,009 $ 1,899 $ 3,610 1,155 875 2,214 2,477 1,773 2,884 4,113 6,087 (1,773 ) (2,884 ) (4,113 ) (6,087 ) 72 55 108 124 $ (1,701 ) $ (2,829 ) $ (4,005 ) $ (5,963 ) $ (1.66 ) $ (41.82 ) $ (5.18 ) $ (106.44 ) 1,026,506 67,654 772,397 56,025 $ 8 $ 5 $ 16 $ 242 $ 31 $ 15 $ 61 $ 365 Investors: Cliff Mastricola Investor Relations cmastricola@dermatarx.com SOURCE: Dermata Therapeutics Released August 13, 2025

Phase 3Financial StatementPhase 2Clinical Result

08 Jul 2025

·ir.dermatarx.com

Dermata Receives Notice of Grant of Australian Patent for Topical Botulinum Toxin Treatment for Hyperhidrosis

- This is the Company's second granted patent for DMT410, using its Spongilla technology to topically deliver botulinum toxin for hyperhidrosis - - The Company recently entered into a Clinical Trial Collaboration Agreement with Revance to study DMT410 for the treatment of axillary hyperhidrosis - SAN DIEGO, CA / ACCESS Newswire / July 8, 2025 / Dermata Therapeutics, Inc. (NASDAQ:DRMA)(NASDAQ:DRMAW) ("Dermata" or the "Company"), a late-stage biotechnology company focusing on the treatment of medical skin diseases and aesthetic applications, today announced the Australian Patent Office has granted its patent application for its DMT410 program for the treatment of hyperhidrosis. The patent, entitled "Compositions for the treatment of skin conditions," (Australian Patent No. 2109284621) continues to strengthen Dermata's global intellectual property portfolio for DMT410 for the treatment of hyperhidrosis. "We are thrilled to be granted this Australian patent, a testament to our team's relentless innovation and dedication to providing patients with unique and novel treatment options," said Gerry Proehl, Dermata's Chairman, President, and CEO. "We believe this patent reinforces our commitment to pushing boundaries for standard of care for hyperhidrosis patients and delivering groundbreaking solutions that we believe can transform the lives of patients. We are excited about the opportunities the DMT410 program can bring to patients, not only for the treatment of axillary hyperhidrosis, as we have seen in our proof-of-concept study, but potentially for palmer and plantar hyperhidrosis, which remain high unmet needs for patients," Mr. Proehl added. About DMT410 DMT410 is the Company's combination treatment regimen that uses the unique mechanical features of the Company's XYNGARI™ product candidate to facilitate the intradermal delivery of botulinum toxin by topical application rather than through multiple injections with a needle. The treatment consists of an initial topical application of XYNGARI™ to the treatment area where the microscopic spicules penetrate the stratum corneum to create microchannels into the dermis allowing for the topical application and penetration of botulinum toxin. The Company has successfully completed proof-of-concept Phase 1 clinical trials using DMT410 in combination with BOTOX® for the treatment of primary axillary hyperhidrosis and for the treatment of multiple aesthetic skin conditions. Both studies showed promising efficacy results and appeared to be safe and well tolerated by patients. The Company is also planning to initiate a Phase 2a study of DMT410 (XYNGARI™ with DAXXIFY®) for the treatment of axillary hyperhidrosis. About Dermata Therapeutics Dermata Therapeutics is a late-stage biotechnology company focusing on the treatment of medical skin diseases and aesthetic applications. Dermata's lead product candidate, XYNGARI™ (formerly DMT310), is its first product candidate being developed from its Spongilla technology platform. XYNGARI™ is a once-weekly, topical product candidate derived from a naturally sourced freshwater sponge with multiple unique mechanisms of action that recently achieved positive data in a Phase 3 STAR-1 study for the treatment of moderate-to-severe acne. In addition to acne, XYNGARI™ has been studied for the treatment of psoriasis and rosacea. Dermata's second program, DMT410, uses XYNGARI™ as a new method for needle-free intradermal delivery of botulinum toxin for the treatment of multiple aesthetic and medical skin diseases and conditions. Dermata is headquartered in San Diego, California. For more information, please visit http://www.dermatarx.com/. Forward-Looking Statements Statements in this press release that are not strictly historical in nature are forward-looking statements. These statements are based on the Company's current beliefs and expectations and new risks may emerge from time to time. Forward-looking statements are subject to known and unknown risks, uncertainties, assumptions, and other factors including, but are not limited to, statements related to: expectations with regard to the timing of meetings and/or responses from submissions with regulatory bodies, including the FDA; the uncertainties inherent in clinical trials; expectations with regard to any potential partnership opportunities for any of the Company's product candidates; the Company's expectations with regard to current cash and cash equivalents and the amount of time it will fund operations; the success, cost, and timing of its product candidate DMT410 development activities and ongoing and planned clinical trials; whether the results of any planned clinical trials of DMT410 will lead to future product development; whether pending patent applications will proceed to allowance without interruption, if at all; and whether pending, accepted, or issued patents will provide adequate protection for the Company's product candidates, if approved. These statements are only predictions based on current information and expectations and involve a number of risks and uncertainties. Actual events or results may differ materially from those projected in any of such statements due to various factors, including the risks and uncertainties inherent in drug development, approval, and commercialization, and the fact that past results of clinical trials may not be indicative of future trial results. For a discussion of these and other factors, please refer to Dermata's filings with the Securities and Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. This caution is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. All forward-looking statements are qualified in their entirety by this cautionary statement and Dermata undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof, except as required by law. Investors: Cliff Mastricola Investor Relations cmastricola@dermatarx.com SOURCE: Dermata Therapeutics Released July 8, 2025

Clinical ResultPhase 1Phase 3

100 Deals associated with Daxibotulinumtoixn A-LANM

R&D Status

Approved

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Indication	Country/Location	Organization	Date
Dystonic Disorders	China	Shanghai Fosun Pharmaceutical Industrial Development Co., Ltd.	22 Nov 2024
cervical dystonia	United States	Revance Therapeutics, Inc.	11 Aug 2023
Glabellar frown lines	United States	Revance Therapeutics, Inc.	07 Sep 2022

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Torticollis	NDA/BLA	United States	Revance Therapeutics, Inc.	20 Oct 2022
Isolated cervical dystonia	Phase 3	United States	Revance Therapeutics, Inc.	20 Jun 2018
Isolated cervical dystonia	Phase 3	Austria	Revance Therapeutics, Inc.	20 Jun 2018
Isolated cervical dystonia	Phase 3	Canada	Revance Therapeutics, Inc.	20 Jun 2018
Isolated cervical dystonia	Phase 3	Czechia	Revance Therapeutics, Inc.	20 Jun 2018
Isolated cervical dystonia	Phase 3	France	Revance Therapeutics, Inc.	20 Jun 2018
Isolated cervical dystonia	Phase 3	Germany	Revance Therapeutics, Inc.	20 Jun 2018
Isolated cervical dystonia	Phase 3	Poland	Revance Therapeutics, Inc.	20 Jun 2018
Isolated cervical dystonia	Phase 3	Spain	Revance Therapeutics, Inc.	20 Jun 2018
Isolated cervical dystonia	Phase 3	United Kingdom	Revance Therapeutics, Inc.	20 Jun 2018

Clinical Result

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


CTR20202553 (Pubmed)	-	Facial wrinkles	307	Daxxify	lyteinkaxj(xuwyonignt) = nrdfqsgqnj fvxfgqpwkk (boplnlbaaj ) View more	Positive	01 Dec 2024
				安慰剂	lyteinkaxj(xuwyonignt) = sfxqoguzgv fvxfgqpwkk (boplnlbaaj )
ASPEN-1 (MDS2024)	Phase 3	cervical dystonia	321	DaxibotulinumtoxinA	ljaaijcbva(lkoldonikc) = nztirbvgzf zityaotrhk (umofdzxjrc ) View more	Positive	27 Sep 2024
AAN2024	Not Applicable	cervical dystonia	-	DaxibotulinumtoxinA	spsmfiinro(kqgolhizxa) = guljiqecwf nqjfyrdiyr (esuquakpmj ) View more	-	09 Apr 2024
NCT02973269 (CTgov)	Phase 2	Fasciitis, Plantar	7	daxibotulinumtoxin type A (DAXI 240 U)	pkppbujwck(yefcmvthja) = rcibfqsrev wmstiyqnue (ucyjytlrrv, 11.0) View more	-	03 Apr 2024
				Placebo (Placebo)	pkppbujwck(yefcmvthja) = wpofumcocx wmstiyqnue (ucyjytlrrv, 12.1) View more
NCT03608397 \| EUCTR2018-000446-19-AT (ASPEN-1, Pubmed \| Neurology) Manual	Phase 3	cervical dystonia	301	DAXI125U	bwtuxgtusx(smlryjioda) = khrzeidcqe kdwghfuuib (gjkpxbpnql, 1.30) View more	Positive	31 Jan 2024
				DAXI250U	bwtuxgtusx(smlryjioda) = fsgfnccuvv kdwghfuuib (gjkpxbpnql, 1.25) View more
NCT03825315 (CTgov)	Phase 2	Fasciitis, Plantar	155	DAXI 80 U (DAXI 80 U)	hmsbjerwth(fsvmyknnxd) = wbkcxacehx jziprgtylo (dbucrvpifz, 0.329) View more	-	21 Sep 2023
				DAXI 120 U (DAXI 120 U)	hmsbjerwth(fsvmyknnxd) = hiawfnepjs jziprgtylo (dbucrvpifz, 0.298) View more
NCT03821402 (JUNIPER, CTgov)	Phase 2	Stroke \| Limb spasticity \| Brain Injuries, Traumatic ... View more	83	DAXI (DAXI 250 U)	mqgdzigcvw(cyvynmxycb) = dsgjvqtcrs aohmjeoofq (vmpotywruy, 0.25) View more	-	21 Sep 2023
				DAXI (DAXI 375 U)	mqgdzigcvw(cyvynmxycb) = pziztitoqj aohmjeoofq (vmpotywruy, 0.26) View more
NCT03608397 (FDA) Manual	Phase 3	cervical dystonia	301	Placebo	dnjvrisjua(nmrtzoflmm) = zuublgqdgr pqwhjpfpfd (xdngzskmsj )	Positive	11 Aug 2023
				DAXI 125 U	dnjvrisjua(nmrtzoflmm) = yqogtczyru pqwhjpfpfd (xdngzskmsj )
GL-2 (FDA) Manual	Not Applicable	Glabellar frown lines	609	DAXXIFY (STUDY GL-1)	iolentbhln(xmfumsruxx) = vnntrjrbai lsmqsjslzj (tpcecyjxqi ) View more	Positive	11 Aug 2023
				Placebo (STUDY GL-1)	iolentbhln(xmfumsruxx) = woitozgmir lsmqsjslzj (tpcecyjxqi ) View more
NCT03911102 (CTgov)	Phase 2	Lateral Canthal Lines	63	DaxibotulinumtoxinA for injection (Cohort 1: DAXI 12 U)	nbucnxxdei = cysdvnokhh qdpnppozjz (ucibniowee, bmixfgqgdw - nenhmslktx) View more	-	27 Jun 2023
				DaxibotulinumtoxinA for injection (Cohort 2: DAXI 24 U)	nbucnxxdei = fnicdczejf qdpnppozjz (ucibniowee, dfrbnusvlt - dmkxeezlqp) View more

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