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 Mar 2025·OPHTHALMIC PLASTIC AND RECONSTRUCTIVE SURGERY

Successful Treatment of Severe, Poorly Controlled Benign Essential Blepharospasm with DaxibotulinumtoxinA

Article

Author: Kikkawa, Don O. ; Sargsyan, Suzan ; Dib El Jalbout, Nahia ; Korn, Bobby S. ; Liu, Catherine Y. ; Al-Sharif, Eman ; Shoji, Marissa K.

Benign essential blepharospasm is a focal dystonia characterized by involuntary contractions of the orbicularis oculi. Botulinum toxin type A injections are often first-line treatment, but patients may experience refractory symptoms or decreased response over time. DaxibotulinumtoxinA, a novel botulinum toxin type A product, has shown promise in cervical dystonia and facial rhytids but has not been previously reported for benign essential blepharospasm treatment. This case highlights a 57-year-old male with severe, poorly controlled benign essential blepharospasm despite high-dose injections of onabotulinumtoxinA and incobotulinumtoxinA. He subsequently received 100 units of daxibotulinumtoxinA in the same periorbital injection pattern with subjective faster onset, extended duration of effect, and improved symptom management compared to previous treatments. Notably, the patient experienced 50% to 75% efficacy retention at 3 months postinjection, significantly better than his response to other botulinum toxin type A products. This case suggests that daxibotulinumtoxinA may be an effective treatment for benign essential blepharospasm including patients experiencing poor symptom control with other botulinum toxin type A products.

01 Feb 2025·PM&R

A randomized, double‐blind, placebo‐controlled trial of DaxibotulinumtoxinA for Injection for the treatment of upper limb spasticity in adults after stroke or traumatic brain injury

Article

Author: Ayyoub, Ziyad ; Kazerooni, Rashid ; Gross, Todd M. ; Munin, Michael C. ; Francisco, Gerard E. ; Patel, Atul T.

Abstract:

Background:

Intramuscular injection of botulinum toxin type A is a first‐line pharmacotherapy for adults with upper limb spasticity (ULS). However, reemergence of symptoms within 12 weeks of treatment is common and longer‐lasting treatments are needed.

Objective:

To evaluate the efficacy and safety of three doses of DaxibotulinumtoxinA for Injection (DAXI) for treatment of ULS in adults with stroke or traumatic brain injury.

Intervention:

Intramuscular injections of placebo (N = 24), DAXI 250 U (N = 22), DAXI 375 U (N = 19), or DAXI 500 U (N = 18) to the suprahypertonic muscle (SMG) and other muscle groups.

Design:

Randomized, double‐blind, placebo‐controlled study.

Setting:

Twenty‐six study centers across the United States.

Participants:

Eighty‐three adult patients with ULS were randomly assigned to each treatment group and followed for up to 36 weeks.

Outcome Measures:

Co‐primary endpoints were the Modified Ashworth Scale (MAS) score change from baseline in the designated SMG and Physician Global Impression of Change (PGIC) at Week 6.

Results:

The mean changes from baseline in MAS score for the designated SMG for placebo and the DAXI 250 U, 375 U, and 500 U groups were −0.6, −0.9, −0.9, and −1.8, respectively, at Week 4 and −0.8, −0.9, −1.0, and −1.5, respectively, at Week 6. Statistically significant improvement in MAS score compared with placebo was reported only for the 500 U dose (Week 4: p < .001; Week 6: p = .049). Significant improvements in PGIC ratings compared with placebo were reported for DAXI 375 U (p = .015) and DAXI 500 U (p = .009) at Week 4 but not for any DAXI doses at Week 6. All DAXI doses were well tolerated with no trend toward more adverse events with increased dose.

Conclusion:

Results from this Phase 2 study indicate that DAXI 500 U is effective and well tolerated for treatment of adults with ULS.

01 Jan 2025·JOURNAL OF VOICE

DaxibotulinumtoxinA Treatment for Laryngeal Respiratory Dystonia

Article

Author: Rosen, Clark A ; Marshall, Camryn

BACKGROUND:

Laryngeal respiratory dystonia (LRD) is diagnosed based on clinical presentation, patient history, and physical examination. Key indicators include dyspnea, desynchronized breathing patterns, and laryngoscopic findings that reveal vocal fold adduction during inspiration. Treatment for LRD remains controversial and often yields limited effectiveness. While botulinum toxin type A (BtxA) is commonly injected into the thyroarytenoid-lateral cricothyroid (TA-LCA) muscle complex, there are cases where injections into the interarytenoid (IA) muscle have also proven beneficial. DaxibotulinumtoxinA (DAXI) is an emerging therapy that has shown promising effectiveness and safety across various conditions, including cervical dystonia. In this report, we present the first documented use of DAXI specifically for LRD, highlighting the significant benefits experienced by the patient compared to previous treatments with BtxA.

CASE:

A 77-year-old man presented with a 1-year history of significant shortness of breath. Laryngeal endoscopy demonstrated inappropriate adduction of the patient's vocal folds during respiration, suggestive of LRD. The patient received their first Botox (BtxA) injection in May 2018 and has since undergone a total of 40 injections. The patient had a variable response to BtxA injection into his TA-LCA muscle complex, experiencing general improvement in breathing but frequent negative impact on voice and swallowing function. In November of 2021, electromyography-guided BtxA injection into the patient's IA muscle was performed with significant improvement in results. The patient described near-complete resolution of his LRD breathing symptoms with minimal voice changes and a duration of benefit of ~50 days. In November of 2023, DAXI injection into the patient's IA muscle was performed. The patient self-reported a complete resolution of his symptoms for a total duration of benefit of 91 days. Subsequent injections with DAXI in February and May of 2024 had near identical responses.

CONCLUSION:

DAXI appears to provide ~80% better duration than the patient's average BtxA injection and a 57% improvement than his best BtxA injection. DAXI is a safe and realistic alternative to BtxA injection in patients with LRD.

News (Medical) associated with Daxibotulinumtoixn A-LANM

14 May 2025

·investors.aeonbiopharma.com

AEON Biopharma Reports First Quarter 2025 Financial Results and Provides Corporate Update

– Continue to conduct analytical studies to prepare for a potential Biosimilar Biological Product Development (“BPD”) Type 2a meeting with the FDA in the second half of 2025 – – Pursuing a 351(k) regulatory pathway for ABP-450, which offers potential access to the U.S. market under a single approval for all of BOTOX’s currently approved and future therapeutic indications – – Appointed Rob Bancroft as the Company’s President and Chief Executive Officer; Mr. Bancroft also joined AEON’s Board of Directors – IRVINE, Calif., May 14, 2025 (GLOBE NEWSWIRE) -- AEON Biopharma, Inc. (“AEON” or the “Company”) (NYSE: AEON), a clinical-stage biopharmaceutical company focused on developing a botulinum toxin complex for the treatment of multiple therapeutic indications, announced its financial results for the first quarter ended March 31, 2025, and provided a business update. “I am excited to report that our team is quickly advancing the biosimilar development program for ABP-450 under the 351(k) regulatory pathway utilizing BOTOX as the reference product. By utilizing this pathway, we plan to bring ABP-450 to the U.S. market under a single FDA approval that could cover all of BOTOX’s currently approved and future therapeutic indications,” commented Rob Bancroft, AEON’s President and Chief Executive Officer. “We are making progress in conducting the primary analytical studies. Once the initial analytical studies are completed, we will be able to conduct the primary comparative analytical assessment, which the FDA will evaluate at our Biosimilar BPD Type 2a meeting and determine the next steps for the program.” “Once we successfully complete the FDA's rigorous approval process for ABP-450 as a biosimilar to Botox, we believe our therapeutic neurotoxin has the potential to offer a more economically viable solution that would enhance patient access and optimize cost-efficiency for payers and healthcare providers. These changes would likely be widely welcomed by these stakeholders, given the current dynamics of the therapeutic toxin market, which is estimated to be at least $3.3 billion worldwide and predominantly controlled by a single toxin,” concluded Mr. Bancroft. Recent Clinical and Corporate Highlights Advancing its development plan for ABP-450 utilizing 351(k) regulatory pathway for biosimilars – The Company is pursuing a 351(k) biosimilar regulatory pathway for ABP-450 (prabotulinumtoxinA) injection, using BOTOX® (onabotulinumtoxinA) as a proposed reference product for all of the therapeutic indications for which BOTOX is approved. The Company believes it is aligned with the FDA on the initial key requirements to proceed with the 351(k) regulatory pathway. The Company continues to conduct the primary analytical studies to fulfill the standard regulatory requirements for a comparative analytical assessment (CAA). Extensive preclinical toxicology and other data have been previously generated by the Company’s licensing partner. The Company plans to hold a Biosimilar Biological Product Development (BPD) Type 2a meeting with FDA in the second half of 2025 to discuss the outcome from these studies and determine the next steps in development. Management Changes – The Company appointed Rob Bancroft as President and Chief Executive Officer, effective April 29, 2025. He was also appointed to the Company’s Board of Directors. Mr. Bancroft has over 25 years of leadership experience in the life sciences industry, spanning biopharmaceuticals, medical devices, and healthcare technology. Prior to joining AEON, he served as General Manager of the Therapeutics business at Revance Therapeutics, where he led the launch of Daxxify® in cervical dystonia with a novel strategy that prioritized expert endorsement, payer coverage, and reimbursement infrastructure ahead of broader investment - driving strong early adoption and differentiated positioning in the $3.3 billion botulinum toxin therapeutics market. Former CEO, Marc Forth, to remain as a member of the Company’s Board of Directors, through which he will continue to advise the Company’s management team and provide strategic guidance. Liquidity and Capital Resources – The Company reported cash and cash equivalents of $10.4 million as of March 31, 2025, which is expected to be sufficient to fund the Company’s operating plan through the fourth quarter of 2025 and its planned BPD Type 2a meeting with the FDA targeted in the second half of 2025. NYSE American Listing – AEON recently announced the NYSE American LLC (“NYSE American”) accepted the Company's previously submitted plan to regain compliance with continued listing standards relating to minimum market capitalization and stockholders' equity. The NYSE American granted the Company until August 3, 2026 to regain compliance with the continued listing standards, subject to the Company’s continued monitoring by NYSE American in the interim. The Company continues to conduct the primary analytical studies to fulfill the standard regulatory requirements for a comparative analytical assessment (CAA). Extensive preclinical toxicology and other data have been previously generated by the Company’s licensing partner. The Company plans to hold a Biosimilar Biological Product Development (BPD) Type 2a meeting with FDA in the second half of 2025 to discuss the outcome from these studies and determine the next steps in development. Former CEO, Marc Forth, to remain as a member of the Company’s Board of Directors, through which he will continue to advise the Company’s management team and provide strategic guidance. About AEON Biopharma AEON is a clinical stage biopharmaceutical company focused on developing its proprietary botulinum toxin complex, ABP-450 (prabotulinumtoxinA) injection, or ABP-450, for debilitating medical conditions. ABP-450 is the same botulinum toxin complex that is currently approved and marketed for cosmetic indications by Evolus under the name Jeuveau. ABP-450 is manufactured by Daewoong in compliance with current Good Manufacturing Practice, or cGMP, in a facility that has been approved by the U.S. Food and Drug Administration, Health Canada and European Medicines Agency. The product is approved as a biosimilar in Mexico and India. AEON has exclusive development and distribution rights for therapeutic indications of ABP-450 in the United States, Canada, the European Union, the United Kingdom, and certain other international territories. The Company has built a highly experienced management team with specific experience in biopharmaceutical and botulinum toxin development and commercialization. To learn more about AEON, visit www.aeonbiopharma.com. Forward-Looking Statements Certain statements in this press release may be considered forward-looking statements. Forward-looking statements generally relate to future events or AEON’s future financial or operating performance. For example, statements regarding meetings with the FDA, the timing of primary comparative analytical studies, and potential determination that ABP-450 is highly similar to the reference product for currently approved and future therapeutic indications are forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as "plan", "possible", "forecast", "expect", "intend", "will", "estimate", "anticipate", "believe", "predict", "potential" or "continue", or the negatives of these terms or variations of them or similar terminology. Such forward-looking statements are subject to risks, uncertainties, and other factors which could cause actual results to differ materially from those expressed or implied by such forward-looking statements. These forward-looking statements are based upon estimates and assumptions that, while considered reasonable by AEON and its management, are inherently uncertain. Factors that may cause actual results to differ materially from current expectations include, but are not limited to: (i) the outcome of any legal proceedings that may be instituted against AEON or others; (ii) AEON’s future capital requirements; (iii) AEON’s ability to raise financing in the future; (iv) AEON’s ability to continue to meet continued stock exchange listing standards; (v) the possibility that AEON may be adversely affected by other economic, business, regulatory, and/or competitive factors; (vi) the outcomes from any meetings or discussions with regulatory authorities; and (vii) other risks and uncertainties set forth in the section entitled “Risk Factors” and “Cautionary Note Regarding Forward-Looking Statements” in the Company’s filings with the Securities and Exchange Commission (the "SEC"), which are available on the SEC’s website at www.sec.gov. Nothing in this press release should be regarded as a representation by any person that the forward-looking statements set forth herein will be achieved or that any of the contemplated results of such forward-looking statements will be achieved. You should not place undue reliance on forward-looking statements, which speak only as of the date they are made. AEON does not undertake any duty to update these forward-looking statements. Contacts Investor Contact: Corey Davis, Ph.D. LifeSci Advisors +1 212 915 2577 cdavis@lifesciadvisors.com Source: AEON Biopharma The accompanying condensed consolidated financial statements have been prepared in accordance with generally accepted accounting principles in the United States of America (“U.S. GAAP”) and include the accounts of the Company and its controlled subsidiaries.

Executive ChangeDrug ApprovalFinancial StatementPDC

14 May 2025

·ir.dermatarx.com

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

- Dermata announced positive topline results from its XYNGARI™ Phase 3 Spongilla Treatment of Acne Research (STAR-1) clinical trial, achieving all co-primary endpoints - - Dermata entered into a Clinical Trial Collaboration Agreement with Revance Therapeutics to study DMT410 with DAXXIFY® for the treatment of axillary hyperhidrosis - - Raised $8.8 million in gross proceeds from private placement and warrant inducement financings during the first quarter of 2025 - SAN DIEGO, CA / ACCESS Newswire / May 14, 2025 / Dermata Therapeutics, Inc. (NASDAQ:DRMA)(NASDAQ: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 first quarter ended March 31, 2025. "It was an exciting quarter for our team to announce positive topline results of the XYNGARI™ Phase 3 STAR-1 trial for the treatment of acne, which achieved statistically significant results of its three co-primary endpoints at all time points," commented Gerry Proehl, Dermata's Chairman, President, and Chief Executive Officer. "Our team has spent many years working with this product and knew it had strong potential as a treatment for acne and we are happy to see that hard work has paid off with such positive results. We believe the consistent results from our previous clinical studies and this Phase 3 trial derisks the planned second Phase 3 trial and well positions XYNGARI™ to potentially be the first once-weekly, natural, topical treatment for moderate-to-severe acne, if approved. We are also excited to have partnered with Revance to study DMT410 with DAXXIFY® for the topical treatment of axillary hyperhidrosis," continued Mr. Proehl. "We see a lot of potential uses for our DMT410 program and studying it in a Phase 2 study with a long-lasting botulinum toxin, like DAXXIFY®, could provide us with the data needed to show the clinical efficacy of DMT410 aiding in the topical delivery of a botulinum toxin," 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 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, further demonstrating its rapid onset of action. STAR-1 is the first of two Phase 3 clinical trials, the second of which will include a 9-month extension study, which the Company will 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 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, further demonstrating its rapid onset of action. STAR-1 is the first of two Phase 3 clinical trials, the second of which will include a 9-month extension study, which the Company will need to complete prior to filing a new drug application with the U.S. Food and Drug Administration. Signed Clinical Trial Collaboration Agreement for DMT410 with Revance. In January 2025, Dermata entered into a Clinical Trial Collaboration Agreement with Revance, where Dermata and Revance intend to conduct a Phase 2a trial to evaluate XYNGARI™, Dermata's topical Spongilla product candidate, with DAXXIFY®, Revance's botulinum toxin product, for the topical treatment of axillary hyperhidrosis. If successful, the companies may agree to further clinical development in hyperhidrosis and potentially other indications, like acne, rosacea, and facial aesthetics. Signed Clinical Trial Collaboration Agreement for DMT410 with Revance. In January 2025, Dermata entered into a Clinical Trial Collaboration Agreement with Revance, where Dermata and Revance intend to conduct a Phase 2a trial to evaluate XYNGARI™, Dermata's topical Spongilla product candidate, with DAXXIFY®, Revance's botulinum toxin product, for the topical treatment of axillary hyperhidrosis. If successful, the companies may agree to further clinical development in hyperhidrosis and potentially other indications, like acne, rosacea, and facial aesthetics. Raised $8.8 million in gross proceeds during the first quarter 2025. The funds raised during the first quarter 2025 are expected to fund Dermata's operations into the first quarter of 2026. Raised $8.8 million in gross proceeds during the first quarter 2025. The funds raised during the first quarter 2025 are expected to fund Dermata's operations into the first quarter of 2026. Anticipated Upcoming Milestones Initiate the second XYNGARI™ Phase 3 STAR-2 clinical trial in moderate-to-severe acne. With positive results from the STAR-1 trial, Dermata has begun the manufacturing campaign for the STAR-2 trial and plans to initiate the second Phase 3 trial of XYNGARI™ for the treatment of moderate-to-severe acne by the end of 2025. The STAR-2 trial will be followed by a 9-month extension study. Dermata has commenced discussions regarding potential partnerships for the STAR-2 trial and/or commercial rights to XYNGARI™. Initiate the second XYNGARI™ Phase 3 STAR-2 clinical trial in moderate-to-severe acne. With positive results from the STAR-1 trial, Dermata has begun the manufacturing campaign for the STAR-2 trial and plans to initiate the second Phase 3 trial of XYNGARI™ for the treatment of moderate-to-severe acne by the end of 2025. The STAR-2 trial will be followed by a 9-month extension study. Dermata has commenced discussions regarding potential partnerships for the STAR-2 trial and/or commercial rights to XYNGARI™. Continue preparation of DMT410 Phase 2a clinical study with Revance. Dermata 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. Continue preparation of DMT410 Phase 2a clinical study with Revance. Dermata 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. First Quarter 2025 Financial Results As of March 31, 2025, the Company had $9.7 million in cash and cash equivalents, compared to $3.2 million as of December 31, 2024. The $6.6 million increase in cash and cash equivalents for the quarter ended March 31, 2025, resulted from approximately $8.5 million of financing proceeds offset by $1.9 million of cash used in operations. The Company expects its current cash resources to be sufficient to fund operations into the first quarter of 2026. Research and development expenses were $1.3 million for the quarter ended March 31, 2025, compared to $1.6 million for the quarter ended March 31, 2024. The decrease in research and development expenses was the result of $0.1 million of decreased clinical trial expenses from the XYNGARI™ STAR-1 acne study, which completed enrollment during the fourth quarter of 2024, and $0.2 million of decreased stock-based compensation resulting from the cancellation of out-of-the-money stock options during the first quarter of 2024. General and administrative expenses were $1.1 million for the quarter ended March 31, 2025, compared to $1.6 million for the same period in 2024. The decrease in general and administrative expenses resulted from $0.3 million of decreased stock-based compensation expenses and $0.2 million of decreased audit fees. Stock-based compensation attributable to general and administrative totaled $30K for the quarter ended March 31, 2025, compared to $0.4 million for the quarter ended March 31, 2024, which included a one-time charge for the cancellation of out-of-the-money stock options. Audit fees decreased from $0.4 million for the quarter ended March 31, 2024, to $0.2 million for the quarter ended March 31, 2025. The decrease in audit fees resulted from the Company's use of one audit firm for 2025, whereas it had used two firms in 2024 after Meyer Hoffman McCann (CBIZ) (the Company's former audit firm) stopped auditing public companies. 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 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 they 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 March 31, 2025 December 31, 2024 (unaudited) $ 9,719 $ 3,162 286 372 10,005 3,534 1,395 808 1,308 1,165 2,703 1,973 7,302 1,561 $ 10,005 $ 3,534 DERMATA THERAPEUTICS, INC. Statements of Operations (unaudited) Quarter Ended March 31, 2025 2024 $ 1,281 $ 1,600 1,058 1,603 2,339 3,203 (2,339 ) (3,203 ) 36 69 $ (2,303 ) $ (3,134 ) $ (0.45 ) $ (7.06 ) 5,154,698 443,998 $ 8 $ 237 $ 29 $ 350 Investors: Cliff Mastricola Investor Relations cmastricola@dermatarx.com SOURCE: Dermata Therapeutics Released May 14, 2025

Phase 3Phase 2Financial StatementClinical Result

26 Mar 2025

·www.prnewswire.com

Fosun Pharma Announces 2024 Annual Results

Accelerates Globalization of Innovative Products with Operating Cash Flow Surging 31.13% YoY SHANGHAI, March 25, 2025 /PRNewswire/ -- On March 25, 2025, Shanghai Fosun Pharmaceutical (Group) Co., Ltd. ("Fosun Pharma"or "the Group"; Stock Code: 600196.SH, 02196.HK), a leading global pharmaceutical and healthcare company driven by innovation, announced its annual results for the year ended 31 December 2024 ("the Reporting Period"). In 2024, Fosun Pharma further focused on the business development of innovative drugs and high-value devices, achieving operating revenue of RMB41.07 billion and net profit attributable to shareholders of RMB2.77 billion, representing an increase of 16.08% YoY. Fosun Pharma continuously optimize supply chain management to enhance operational efficiency, recording an operating cash flow of RMB4.48 billion with an increase of 31.13% YoY, surpassing the growth rate of operating profit. In addition, Fosun Pharma continues to advance lean management across quality enhancement, cost control, efficiency improvement, cycle management, and innovation R&D, driving operational efficiency and expanding profitability. During the Reporting Period, the gross margin minus the selling and distribution expense ratio improved by 2.45 percentage points YoY; and, excluding the impact of newly acquired enterprises during the Reporting Period and the same period last year, administrative expenses declined by RMB355 million. Fosun Pharma always takes innovation as a core driving force in its development. Fosun Pharma has established an open and globally integrated pharmaceutical R&D ecosystem, focusing on core therapeutic areas including oncology (solid tumors and hematologic malignancies) and Immune-inflammatory disorders. The company is strategically enhancing its technological leadership in antibody/ADC platforms, cell therapies, and small molecule development, while collaborating with industry funds to pioneer next-generation modalities such as radiopharmaceuticals, RNA therapeutics, gene editing, and AI-powered drug discovery. During the Reporting Period, Fosun Pharma continuously optimized its innovative R&D system while maintaining stable R&D investment, focusing on key pipeline strengths and enhancing efficiency through system integration. In 2024, Fosun Pharma's total R&D expenditure amounted to RMB5.55 billion, with R&D expenses totaling RMB3.64 billion. The R&D expenditure in the pharmaceutical manufacturing segment amounted to RMB4.91 billion, accounting for 16.98% of pharmaceutical business revenue. There are over 80 major pipeline projects on innovative drugs and biosimilars (calculated by indications). In addition, during the Reporting Period, the pharmaceutical manufacturing segment of Fosun Pharma submitted 220 patent applications, including 3 American patent applications, 18 PCT applications, and Fosun Pharma has obtained 66 licensed invention patents authorization. Accelerating Innovation Transformation and the Internationalization of Innovative Products Focusing on unmet clinical needs, Fosun Pharma continuous to push forward its innovation transformation and the development and commercialization of innovative products, expanding into regulatory markets such as the U.S. and the EU. During the Reporting Period, 7 innovative products/biosimilars with a total of 16 indications independently developed and licensed-in by Fosun Pharma were approved for launch, and 8 innovative products/biosimilars had entered the pre-launch approval/critical clinical stage. Fosun Pharma also had 18 innovative products/biosimilar projects (calculated by indications) initiated clinical trials. In the field of lung cancer, Fosun Pharma has developed a comprehensive layout in innovative drugs and precision diagnostics and treatment to benefit patients globally. Fosun Pharma's self-developed innovative anti-PD-1 monoclonal antibody, Han Si Zhuang (Serplulimab Injection), is the world's first anti-PD-1 monoclonal antibody (mAb) approved for the first-line treatment of extensive-stage small cell lung cancer (ES-SCLC), and it remains the first and only anti-PD-1 mAb approved in the EU for the treatment of ES-SCLC. During the Reporting Period, Han Si Zhuang also received approval in Chinese mainland for the treatment of non-squamous non-small cell lung cancer (nsNSCLC), and this also marked its third indication in the field of lung cancer, further expanding its reach. To date, Han Si Zhuang has been approved for marketing in over 30 countries and regions, including China, the European Union, and several Southeast Asian nations, benefiting more than 100,000 patients. In addition, to help more lung cancer patients obtain early diagnosis and treatment in a more minimally invasive way, the Ion Bronchial Navigation Operation Control System (Ion System) of Intuitive Fosun, Fosun Pharma's associated company, received NMPA approval in March 2024 and has been commercially deployed. In high-incidence cancers such as breast and gastric cancers, Fosun Pharma's self-developed monoclonal antibody(mAb) biosimilar Han Qu You (Trastuzumab Injection) has been approved for launch in over 50 countries and regions, including China, the European Union, the U.S., Canada and Australia, and has been included in the health insurance directories in countries such as China, UK, France, and Germany. To date, Han Qu You has benefited over 240,000 patients. The HER2-targeted innovative monoclonal antibody HLX22 for gastric cancer treatment and the novel endocrine therapy HLX78 (lasofoxifene) for breast cancer are currently under international multi-center Phase III clinical trials. Additionally, the biosimilar candidate HLX11 (pertuzumab) has had its new drug applications submitted and accepted in both China and the U.S., injecting new momentum into global expansion. In addition, Fosun Pharma is also advancing the development of rare disease drugs. Its self-developed MEK1/2 selective inhibitor Luvometinib tablets, (Project Code: FCN-159), has had its new drug applications for two indications—treatment of adult dendritic cell and histiocytic tumors, and treatment of plexiform neurofibromas (PN) associated with Neurofibromatosis Type 1 (NF1) in children aged 2 years and older—accepted by the NMPA and placed in the priority review process . In the non-oncology field, during the Reporting Period, Fosun Pharma's self-developed and licensed-in rabies vaccine (Vero cell) for human use (freeze dried), Pu Rui Ni (Pretomanid Tablets), Han Da Yuan (Adalimumab Injection) received approval for four new indications, and Su ke Xin (Avatrombopag Malate Tablets) was approved for its second indication in China; meanwhile, the new drug applications for a biosimilar of denosumab HLX14 under development were accepted by the European Medicines Agency (EMA), Health Canada and the FDA, respectively. Continuously Enhancing Global Operations and Bilateral Licensing Cooperation Fosun Pharma continues to uphold the internationalization strategy in multiple dimensions, such as innovative R&D, licensing, manufacturing and operations as well as commercialization. In 2024, overseas revenue reached RMB11.30 billion, accounting for 27.51% of total revenue. During the reporting period, Fosun Pharma continues to promote the building of production system with international quality standard, laying a solid foundation for the overseas distribution of preparations. As of the end of 2024, all production lines of the domestic subsidiaries under the pharmaceutical manufacturing segment of Fosun Pharma obtained domestic GMP certifications and 10 production lines had passed GMP certification in major regulatory markets such as the U.S. and the EU. Fosun Pharma's pharmaceuticals and medical devices businesses now primarily cover major overseas markets, including the United States, Europe, Africa, India, and Southeast Asia, with an overseas commercialization team of over 1,000 employees. In the U.S., Fosun Pharma's in-house generic drug team has continued to grow, establishing partnerships with major distributors and group purchasing organizations (GPOs) to drive the sales of formulation products. Meanwhile, Fosun Pharma has established its innovative drug team in the U.S. and is preparing for the commercialization of its anti-PD-1 monoclonal antibody (mAb), serplulimab injection. In Europe, Gland Pharma has built localized manufacturing capabilities through its subsidiary, Cenexi. Sisram Medical has expanded its global direct sales offices to 12, with its marketing network now covering over 110 countries and regions. The share of direct sales revenue has further increased to 87%. Meanwhile, Breas Medical's marketing network has expanded across key mature markets, including Europe, the United States, Japan, and Australia. In emerging markets, Fosun Pharma's sales network in Africa now covers over 40 countries and regions. The company continues to advance the Côte d'Ivoire park project to establish localized pharmaceutical manufacturing and supply in Africa. In February 2025, Fosun Pharma launched a new pharmaceutical and medical device sales platform in Nanning, gradually enhancing its registration and commercialization capabilities in Southeast Asia to expand its presence in the region. Fosun Pharma is also actively expanding into the Middle East market. During the reporting period, Henlius, a subsidiary of Fosun Pharma, entered into a strategic partnership with SVAX to establish a joint venture in Saudi Arabia. This collaboration aims to enhance the accessibility of innovative and high-value products in the MENAT region (Middle East, North Africa, and Turkey). Fosun Pharma continues to strengthen its global licensing collaboration, further enhancing its international influence and competitiveness. On the out-licensing front, Henlius, a subsidiary of Fosun Pharma has forged deep partnerships with over 20 leading global biopharmaceutical companies, including Accord, Abbott, Eurofarma, KGbio, Organon, and Dr. Reddy's, to jointly expand global markets. These collaborations comprehensively cover major biologics markets in Europe and the U.S., as well as numerous emerging markets. To date, its approved biologics have benefited more than 750,000 patients worldwide. Fosun Pharma continues to expand its product pipeline in core therapeutic areas through strategic global collaborations. Licensed-in products such as the antiemetic Akynzeo® (netupitant/palonosetron capsules), long-lasting recombinant human granulocyte colony-stimulating factor product (Pei Jin) and the drug for heart failure and hypertension treatment (Yi Xin Tan) have been included in the National Medical Insurance Drugs Catalogue, benefiting a wide range of patients. Fosun Pharma has obtained exclusive development and commercialization rights for Tenapanor Hydrochloride Tablets (Wan Ti Le), a first-in-class phosphate-lowering drug with a novel mechanism. In February 2025, the drug received approval from the National Medical Products Administration (NMPA) in China for the treatment of hyperphosphatemia in adult dialysis patients with chronic kidney disease (CKD). This approval marks a new era of multi-mechanism phosphate control, bringing new hope to dialysis patients with hyperphosphatemia. During the reporting period, Fosun Pharma's licensed product Daxxify® (DaxibotulinumtoxinA-lanm) became the first of its kind approved in China. The product received NMPA approval for the improvement in the appearance of moderate to severe glabellar lines associated with corrugator and/or procerus muscle activity in adult patients. Accelerating Localization of Innovative Products in China to Achieve High-quality Development As a global innovation-driven pharmaceutical and healthcare company, Fosun Pharma actively introduces internationally advanced technologies and products to the Chinese market, benefiting patients and customers. During the reporting period, Fosun-Insightec, a joint venture established with Insightec in China, successfully achieved sales of magneticresonance image guided focused ultrasound brain therapy system ("MRgFUS brain therapy system") for brain treatment. Additionally, the headquarters and industrial base of Intuitive Fosun, an associated company, was officially inaugurated in the Zhangjiang International Medical Park in Shanghai. This facility integrates R&D, manufacturing, and training, further accelerating the localization of the da Vinci Robotic surgical systems in China. To further enhance its leading position in tumor immunotherapy, Fosun Pharma increased its stake in its cell therapy platform, Fosun Kairos, to 100% during the reporting period. The company will continue to collaborate with Kite Pharma to advance the development and commercialization of its licensed products, Axi-Cel (marketed as Yi Kai Da ) and Brexu-Cel (investigational project FKC889), in Chinese mainland, Hong Kong S.A.R and Macao S.A.R. Yi Kai Da became the first in China to introduce an innovative outcome-based payment model. As of the end of 2024, Yi Kai Da has benefited over 800 lymphoma patients, been included in more than 110 provincial and municipal government-backed insurance programs and over 80 commercial insurance plans, and has been registered in more than 180 treatment centers across 28 provinces and municipalities nationwide. While maintaining steady operations, Fosun Pharma remains committed to its corporate social responsibilities. In 2024, the company received multiple domestic and international accolades for its significant progress in ESG, including recognition as one of China's ESG Listed Company Pioneer 100, Deloitte's China Best Managed Companies, Charity Star, and Forbes 2024 China ESG 50 list. Additionally, Fosun Pharma's MSCI ESG rating remained at A. "Fosun Pharma will continue to adhere to innovation-driven and global development strategies, actively embrace AI, concentrate resources on core businesses, and persistently advance lean management and enhance operational efficiency." Wu Yifang, Chairman of Fosun Pharma said, "We aim to grow in tandem with China's biopharmaceutical industry and stride into a new phase of high-quality development. Upholding our mission to 'create better health for families worldwide', we will maintain a patient-centric approach, address unmet clinical needs, deepen innovation transformation and global expansion, and strive to become a global leader in healthcare innovation and integration." About Fosun Pharma Founded in 1994, Shanghai Fosun Pharmaceutical (Group) Co., Ltd. ("Fosun Pharma"; SSE: 600196, HKEX: 02196) is a leading innovation-driven global healthcare company operating in the fields of pharmaceuticals, medical devices & diagnostics, and healthcare services. Through its strategic alliance with Sinopharm Group Co., Ltd., Fosun Pharma further extends its capabilities in pharmaceutical commerce. Over the past 30 years since its establishment, Fosun Pharma has maintained deep roots in China while strategically expanding its global presence. The company has been actively implementing its "4IN" strategy -Innovation, Internationalization, Intelligentization, and Integration, with core business operations now spanning major overseas markets including the United States, Europe, Africa, India, and Southeast Asia. At present, Fosun Pharma has established an open and globally integrated pharmaceutical R&D ecosystem, focusing on core therapeutic areas including oncology (solid tumors and hematologic malignancies) and Immune-inflammatory disorders. The company is strategically enhancing its technological leadership in antibody/ADC platforms, cell therapies, and small molecule development, while collaborating with industry funds to pioneer next-generation modalities such as radiopharmaceuticals, RNA therapeutics, gene editing, and AI-powered drug discovery. This multidimensional approach accelerates the translation of innovative therapies into clinical practice, systematically addressing critical unmet medical needs worldwide. Looking ahead, Fosun Pharma remains anchored in its core values of "Care for life, Continuous innovation, Pursuit of excellence and Sustainable partnership". By advancing its global innovation engine and operational excellence, the company strives to be a global leader to integrate pharmaceutical and healthcare innovations, creating better health for families worldwide. SOURCE Fosun Pharma WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Drug ApprovalPhase 3VaccineLicense out/in

100 Deals associated with Daxibotulinumtoixn A-LANM

R&D Status

Approved

10 top approved records.

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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


AAN2024	Not Applicable	cervical dystonia	-	DaxibotulinumtoxinA	fpgnymvlfo(zdjxrbanns) = etlurxzbln jmhnscticv (yjagmkmfkz ) View more	-	09 Apr 2024
AAN2024	Not Applicable	cervical dystonia	-	DaxibotulinumtoxinA for injection (DAXI) 250U	onvzjfpxom(qsyzzxvfji) = xjlxvxaqsy kdysrckthj (sagavdjnpo )	-	09 Apr 2024
NCT02973269 (CTgov)	Phase 2	Fasciitis, Plantar	7	daxibotulinumtoxin type A (DAXI 240 U)	uztkogzakd(jrytlqnjuq) = qbqgxbczlr ddiooumgyb (pqhzpdpxrx, 11.0) View more	-	03 Apr 2024
				Placebo (Placebo)	uztkogzakd(jrytlqnjuq) = foxsfieeyc ddiooumgyb (pqhzpdpxrx, 12.1) View more
NCT03608397 \| EUCTR2018-000446-19-AT (ASPEN-1, Pubmed \| Neurology) Manual	Phase 3	cervical dystonia	301	DAXI125U	imelsmqbya(bsxkythqqz) = yzhzlxmzxa hscsurkbxd (cjbacmarte, 1.30) View more	Positive	31 Jan 2024
				DAXI250U	imelsmqbya(bsxkythqqz) = vvvxzqsvvb hscsurkbxd (cjbacmarte, 1.25) View more
NCT03825315 (CTgov)	Phase 2	Fasciitis, Plantar	155	DAXI 80 U (DAXI 80 U)	npfvksivgs(gymijniasu) = vwevtqyraq rnmmwilubr (epoivfsdik, 0.329) View more	-	21 Sep 2023
				DAXI 120 U (DAXI 120 U)	npfvksivgs(gymijniasu) = pvgzrilbvx rnmmwilubr (epoivfsdik, 0.298) View more
NCT03821402 (JUNIPER, CTgov)	Phase 2	Stroke \| Limb spasticity \| Brain Injuries, Traumatic ... View more	83	DAXI (DAXI 250 U)	ovmvhrxycx(tqdysxadsl) = qrecnwvmte fpczdwtnfj (wslnpanvcj, 0.25) View more	-	21 Sep 2023
				DAXI (DAXI 375 U)	ovmvhrxycx(tqdysxadsl) = hgmjweklll fpczdwtnfj (wslnpanvcj, 0.26) View more
GL-2 (FDA) Manual	Not Applicable	Glabellar frown lines	609	DAXXIFY (STUDY GL-1)	kleeqxtlws(vhythvxwns) = jwhaccxngz quzeuetfqy (akropuaomv ) View more	Positive	11 Aug 2023
				Placebo (STUDY GL-1)	kleeqxtlws(vhythvxwns) = rqodnzbljy quzeuetfqy (akropuaomv ) View more
NCT03608397 (FDA) Manual	Phase 3	cervical dystonia	301	Placebo	emzfpavjqc(xjxlvycdth) = kbtosyxbqb srxyxkttbg (xnwwluymqp )	Positive	11 Aug 2023
				DAXI 125 U	emzfpavjqc(xjxlvycdth) = ubnagunptz srxyxkttbg (xnwwluymqp )
NCT04259086 (CTgov)	Phase 2	Glabellar frown lines	48	DaxibotulinumtoxinA for injection	luwsraquwd = nfldhgwhys fbizaakxcv (hvwmznocee, pzjlmgcjwi - mmfcuafurx) View more	-	27 Jun 2023
NCT03911102 (CTgov)	Phase 2	Lateral Canthal Lines	63	DaxibotulinumtoxinA for injection (Cohort 1: DAXI 12 U)	ezhyyyrimx = wiebnjxpip upcjueludu (hmvtkcrpan, hnaubdebcj - bjyqudzbbo) View more	-	27 Jun 2023
				DaxibotulinumtoxinA for injection (Cohort 2: DAXI 24 U)	ezhyyyrimx = zuszdxhbdz upcjueludu (hmvtkcrpan, csxrhctmye - jfitzhxwtd) View more

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