SNAP25

CHONGQING, China, Sept. 25, 2024 /PRNewswire/ -- MingMed Biotechnology, an innovative company focused on the in-house discovery and development of novel drugs, recently announced that its partially owned subsidiary, Claruvis Pharmaceutical Co., has received approval from the U.S. Food and Drug Administration (FDA) for its Investigational New Drug (IND) application for YY003, the world's first liquid formulation of recombinant BoNT/A, packaged in a pre-filled syringe, developed for the treatment of glabellar lines. "We are thrilled to receive FDA approval to advance the novel liquid formulation of rBoNT/A (YY003) into clinical development. This liquid-formulated recombinant BoNT/A, delivered via a prefilled device, represents a safer and more convenient option for users. The combination of a super-pure, highly effective product and its ease-of-use design offers BoNT/A users an optimized solution," said Dr. Wu Yang, Chief Scientific Officer of Claruvis, who has over 20 years of experience in botulinum toxin research and development. Claruvis Pharmaceutical, one of the few pioneering biotech companies in China, has developed the world's first recombinant BoNT/A product to reach clinical studies. The company recently completed its Phase III clinical trial for treatment of medium to severe glabellar lines and achieved all the study end points. The efficacy, safety and immunogenicity profiles demonstrated in the trial have set a remarkable milestone in the field of cosmetical use of BoNTs. On September 14th, the company has also successfully dosed the first patient in a phase II clinical trial for treatment of adult upper arm spasm in China, setting another new world record utilizing recombinant BoNT/A for the therapeutic indication. The company has started its first Biologics License Application (BLA) in China, backed by a comprehensive set of successful Phase I, II, and III clinical results. Dr. Yang added, "We believe the FDA's approval of YY003 for clinical evaluation is a significant milestone towards launching a high-quality product in the Botulinum toxin market." About MingMed MingMed Biotechnology Co., Ltd. is an innovative company dedicated to the in-house discovery and development of novel drugs that address global unmet medical needs. Our R&D team is led by global top-notch scientists and specialists. Leveraging our research and development capabilities and efficient operations, we have built an internally developed product portfolio with a diverse yet synergistic suite of four major therapeutic areas, namely recombinant botulinum toxin, ophthalmic drugs, immuno-oncology drugs and pet immune drugs. Our product pipelines include a number of first-in-class drug candidates, and the major products have moved forward to commercialization. About Claruvis Pharmaceutical Claruvis, a non-wholly owned subsidiary of MingMed Biotechnology, is strategically focus on the development, production and commercialization of botulinum toxin products utilizing recombinant protein technology. The R&D team is formed by top-notch global scientists and senior American Chinese scholars with in-depth knowledge and experience in botulinum toxin products. Marking a significant milestone, Claruvis has pioneered the development of the world's first recombinant type A BoNT product on a self-developed R&D platform. Excellent operational capability supported by a globally competitive R&D platform will continue to drive Claruvis' innovation and fast development in the rBoNT area to address the vast number of unmet aesthetic and therapeutic medical needs worldwide. Contact: [email protected] SOURCE MingMed Biotechnology WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

- CT1812 Treatment Showed ~40% Mean Improvement in Cognitive Measures vs Placebo -- Consistent Positive Changes Across Cognitive and Functional Measures -- Favorable Safety Profile with Most Treatment-Related Adverse Events Mild or Moderate -- Significant Changes in Neurofilament Light Chain, a Marker of Neurodegeneration -- Investor Webcast to be Conducted at 8:30a.m. ET to Review Findings - PURCHASE, N.Y., July 29, 2024 (GLOBE NEWSWIRE) -- Cognition Therapeutics, Inc. (the “Company” or “Cognition”) (NASDAQ: CGTX), a clinical stage company developing drugs that treat neurodegenerative disorders, today reported that participants in the proof-of-concept Phase 2 ‘SHINE’ study (NCT03507790) who were treated with CT1812 for six months showed a consistent trend in cognitive improvement compared to placebo across all cognitive measures including ADAS-Cog 11, ADAS-Cog 13, cognitive composite and MMSE. In addition, there were signals of improvement in functional measures (ADCS-ADL and ADCS-CGIC). Details of these clinical and biomarker findings are reported in posters at the Alzheimer’s Association’s International Conference on July 29, 2024 in Philadelphia, PA. “The SHINE trial showed that after 182 days of treatment, CT1812 demonstrated evidence of clinical improvements on cognition coupled with a favorable safety and tolerability profile, particularly in the 100mg dose cohort. These findings will inform dose selection and provide a foundation for advancing to the next stage of clinical development,” stated Lisa Ricciardi, president and CEO of Cognition Therapeutics. “We believe these results provide evidence that amyloid oligomer antagonism – a new and distinct mechanism for therapeutic intervention – may have a role as a monotherapy or in a combination with approved drugs for the treatment of AD and related dementias. In terms of percent improvement on evaluated cognitive measures, our results are comparable in magnitude to what was achieved with currently approved antibodies, with great ease of administration as a once daily dose, and less patient burden.” SHINE enrolled 153 adults with mild-to-moderate (MMSE 18-26) Alzheimer's disease who were randomized evenly (1:1:1) to one of two oral daily doses of CT1812 (100mg or 300mg) or placebo. P-values less than 0.05 were observed on ADAS-Cog 11 and MMSE at Day 98, the midpoint of the study. Through the course of the study, participants in the placebo arm worsened approximately 2.70 points as measured by ADAS-Cog 11 on Day 182. In contrast, CT1812-treated participants declined by an average of 1.66 points, a 39% slowing of decline favoring CT1812. Similar results were seen in the MMSE score on Day 98 for the pooled CT1812 arms. On the exploratory measures of function (ADCS-ADL and CGIC), there was a signal of benefit favoring CT1812 at the six-month timepoint. In this study, CT1812 did not achieve statistical significance on the first of the ordered secondary efficacy endpoints in the pooled 100mg and 300mg dose group compared to placebo. CT1812 demonstrated a favorable safety and tolerability profile with most treatment-related adverse events being mild or moderate, consistent with previous clinical experience. “A key objective of this trial was to provide evidence of cognitive benefit potential with CT1812 treatment, which we accomplished,” added Anthony Caggiano, Cognition’s CMO and head of R&D. “We are pleased about the consistent cognitive effect and signals of functional benefit across the entire study. We intend to utilize these findings to enable us to design and power future clinical trials to advance the development of CT1812 in Alzheimer’s disease. We believe that the data supports the advancement of a 100mg dose of CT1812 in additional clinical trials in a mild-to-moderate patient population.” While we are continuing to analyze the exploratory CSF biomarker program data, the study showed favorable changes in neurofilament light chain (NfL), which is a marker of neurodegenerative disease. These changes were significant at the 300mg dose. We believe this finding supports the understanding of the potential role of CT1812 as a synaptoprotective agent. Other CSF biomarkers not approaching significance include neurogranin, synaptotagmin, SNAP25, pTau, total Tau and GFAP. The SHINE study achieved its primary objective and demonstrated a favorable safety and tolerability profile, consistent with previous clinical experience. Overall, the percentage of participants experiencing any adverse event (AE) was similar between the pooled CT1812 treatment arms (76.5%) and the placebo group (78%). The majority of adverse events were mild or moderate in severity. The most commonly reported treatment-emergent adverse events were infections and infestations (urinary tract infection), injury, poisoning and procedural complications (falls and skin lacerations), gastrointestinal disorders and nervous system disorders (headache). In the placebo arm, 10% of participants experienced a serious adverse event (SAE) compared to 6% in the combined CT1812 treated arms. Among CT1812-treated participants, two experienced treatment-emergent SAEs in the 100mg group, including stomatitis, chronic constipation, and hip fracture (all deemed not related to treatment) and three experienced treatment-emergent SAEs in the 300mg group, including hematuria, abdominal pain, and infection (all deemed not related to treatment) and recurrent presyncope (deemed related to treatment). At the 300mg dose, nine patients experienced treatment-emergent LFT increases (greater than 3xULN), which subsided after cessation of drug without evidence of serious liver injury. There were no LFT elevations observed in the 100mg dose. “We are optimistic about the SHINE results and are looking ahead to the results of our SHIMMER trial in mild-to-moderate Lewy body dementia, which is anticipated to read out later this year,” stated Lisa Ricciardi, president and CEO of Cognition Therapeutics. “In addition, we are studying patients with early stage Alzheimer’s disease in our START trial of 540 patients. Another Phase 2 proof-of-concept trial in dry AMD is currently enrolling patients. Cognition is committed to advancing the field of research to provide clinical options for patients with neurodegenerative disease, and we could not have done this without the grant support of over $170M we have received from the NIH, NIA, ADDF and MJFF.” AAIC Presentation detailsTitle:Clinical Efficacy Results from COG0201: a Randomized, Double-Blind, Placebo-Controlled Phase 2 Study to Evaluate the Safety and Efficacy of CT1812 in Adults with Mild-to-Moderate Alzheimer’s DiseaseAuthors:Vijverberg EGB, Catalano S, Hamby ME, Grundman M, Iaci J, Devins T, Caggiano AODate/Time:July 29, 2024: 8:30 a.m. - 4:15 p.m. Eastern TimeLocation:Pennsylvania Convention Center, Philadelphia, PA This and Cognition’s other AAIC posters will be available on the Company’s Publication webpage in accordance with the conference’s embargo policy. Webcast Information Company management will be joined by an investigator in the SHINE study, Everard (Jort) Vijverberg, MD, PhD of the Alzheimer Center Amsterdam and Neuroscience Amsterdam, who will present an overview of the results. In addition, Martin J. Sadowski, MD, PhD, DSci of New York University School of Medicine will participate as an Alzheimer’s industry expert. A live question and answer session will follow formal presentations. Interested parties may register from the event listing on the Cognition Therapeutics Investor Relations webpage under News & Events or directly by visiting https://lifescievents.com/event/cognition/. About the SHINE StudyThe SHINE study is a double-blind, placebo-controlled Phase 2 clinical trial which enrolled 153 adult patients with mild-to-moderate Alzheimer’s disease. Based on the study design, SHINE was powered to detect a 3-point change in ADAS-Cog 11. The primary endpoint was safety and tolerability and the key secondary endpoint cognitive measure was ADAS-Cog 11. Participants were evenly randomized to receive either placebo or one of two doses of CT1812 (100 mg or 300 mg), which was taken orally daily for six months. The SHINE study was supported by two grant awards from the National Institute on Aging of the National Institutes of Health (NIH) totaling approximately $30 million. More information may be found at clinicaltrials.gov under trial ID NCT03507790. About CT1812CT1812 is an experimental orally delivered small molecule oligomer antagonist that penetrates the blood-brain barrier and binds selectively to the sigma-2 (σ-2) receptor complex. Preclinical and clinical data demonstrated that this binding resulted in the displacement of toxic Aβ oligomers. The σ-2 receptor complex is involved in the regulation of key cellular processes such as membrane trafficking and autophagy that are damaged by toxic interaction with Aβ oligomers, oxidative stress and other stressors. This damage to sensitive synapses can progress to a loss of synaptic function, which manifests as cognitive impairment and Alzheimer’s disease progression. Participants are currently being recruited in the SHIMMER study (NCT05225415) of CT1812 in adults with dementia with Lewy bodies; the START study (NCT05531656) of CT1812 in adults with early Alzheimer’s disease; and the MAGNIFY study (NCT05893537) in adults with geographic atrophy (GA) secondary to dry age-related macular degeneration. About Cognition Therapeutics, Inc.Cognition Therapeutics, Inc. is a clinical-stage biopharmaceutical company engaged in the discovery and development of innovative, small molecule therapeutics targeting age-related degenerative disorders of the central nervous system and retina. We are currently investigating our lead candidate CT1812 in clinical programs in Alzheimer’s disease, dementia with Lewy bodies (DLB) and dry age-related macular degeneration (dry AMD). We believe CT1812 and our pipeline of σ-2 receptor modulators can regulate pathways that are impaired in these diseases. We believe that targeting the σ-2 receptor with CT1812 represents a mechanism functionally distinct from other current approaches in clinical development for the treatment of degenerative diseases. More about Cognition Therapeutics and its pipeline can be found at https://cogrx.com Forward Looking Statements This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. All statements contained in this press release, other than statements of historical facts or statements that relate to present facts or current conditions, including but not limited to, statements regarding our product candidates, including CT1812, and any expected or implied benefits or results, including that initial clinical results observed with respect to CT1812 will be replicated in later trials and our clinical development plans, including statements regarding our clinical studies of CT1812 and any analyses of the results therefrom, are forward-looking statements. These statements, including statements relating to the timing and expected results of our clinical trials, involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance, or achievements to be materially different from any future results, performance, or achievements expressed or implied by the forward-looking statements. In some cases, you can identify forward-looking statements by terms such as “may,” might,” “will,” “should,” “expect,” “plan,” “aim,” “seek,” “anticipate,” “could,” “intend,” “target,” “project,” “contemplate,” “believe,” “estimate,” “predict,” “forecast,” “potential” or “continue” or the negative of these terms or other similar expressions. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends that we believe may affect our business, financial condition, and results of operations. These forward-looking statements speak only as of the date of this press release and are subject to a number of risks, uncertainties and assumptions, some of which cannot be predicted or quantified and some of which are beyond our control. Factors that may cause actual results to differ materially from current expectations include, but are not limited to: our ability to successfully advance our current and future product candidates through development activities, preclinical studies and clinical trials and costs related thereto; uncertainties inherent in the results of preliminary data, pre-clinical studies and earlier-stage clinical trials being predictive of the results of early or later-stage clinical trials; the timing, scope and likelihood of regulatory filings and approvals, including regulatory approval of our product candidates; competition; our ability to secure new (and retain existing) grant funding; our ability to grow and manage growth, maintain relationships with suppliers and retain our management and key employees; changes in applicable laws or regulations; the possibility that the we may be adversely affected by other economic, business or competitive factors, including ongoing economic uncertainty; our estimates of expenses and profitability; the evolution of the markets in which we compete; our ability to implement our strategic initiatives and continue to innovate our existing products; our ability to defend our intellectual property; impacts of ongoing global and regional conflicts; the impact of the COVID-19 pandemic on our business, supply chain and labor force; and the risks and uncertainties described more fully in the “Risk Factors” section of our annual and quarterly reports filed with the Securities & Exchange Commission and are available at www.sec.gov. These risks are not exhaustive and we face both known and unknown risks. You should not rely on these forward-looking statements as predictions of future events. The events and circumstances reflected in our forward-looking statements may not be achieved or occur, and actual results could differ materially from those projected in the forward-looking statements. Moreover, we operate in a dynamic industry and economy. New risk factors and uncertainties may emerge from time to time, and it is not possible for management to predict all risk factors and uncertainties that we may face. Except as required by applicable law, we do not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise. Contact Information:Cognition Therapeutics, Inc.info@cogrx.comCasey McDonald (media) Tiberend Strategic Advisors, Inc.cmcdonald@tiberend.comMike Moyer (investors)LifeSci Advisorsmmoyer@lifesciadvisors.com

– Two presentations highlighting data on DAXXIFY® for the treatment of cervical dystonia, including a new analysis from ASPEN trials assessing patient-desired retreatment intervals and one abstract examining the influence of DAXXIFY’s formulation on clinical performance NASHVILLE, Tenn.--(BUSINESS WIRE)-- Revance Therapeutics, Inc. (NASDAQ: RVNC), today announced two poster presentations on DAXXIFY® for the treatment of cervical dystonia at the annual meeting of American Academy of Neurology (AAN), taking place April 13-18, 2024, in Denver, Colorado. In the ASPEN-1 and ASPEN-OLS (open label study), a new analysis found that among patients that requested early retreatment with DAXXIFY®, roughly 50% of peak efficacy remained at the time of their request. In the ASPEN-OLS 52-week long-term follow-up study, approximately 60% of retreatments were at 16 weeks or later. These findings suggest that the long-acting symptom control with DAXXIFY® allows physicians the flexibility to customize treatment intervals for each patient, without being limited by the FDA and payer-defined minimum treatment interval of 12 weeks (as is the case with conventional neurotoxins). Additionally, the studies show that adverse event rates remained low across all retreatment scenarios. “While it may not be surprising that many patients prefer to be retreated as their symptoms first re-emerge rather than waiting to return to baseline, we believe that the duration of DAXXIFY offers the potential for physicians to tailor doses and retreatment intervals to the needs of individual patients, in order to provide sustained symptom control and reduce the symptom rollercoaster experienced by a vast number of those suffering with cervical dystonia,” said David. A. Hollander, MD, MBA, Chief Medical Officer and Global Therapeutics Franchise Lead. A second poster, by Dr. Han Lee and colleagues, examines DAXXIFY’s novel formulation and the role of Revance’s custom-engineered peptide (RTP004), in clinical performance. The data shows that the benefits of RTP004 include increased binding of neurotoxin to cell membranes to allow more toxin to enter the neuron, enhanced SNAP-25 cleavage in neurons in a dose-dependent manner, and localization in the injected muscle. By increasing bioavailability, DAXXIFY’s formulation allows for a lower amount of core neurotoxin to be administered while maintaining long lasting benefit, which may contribute to the strong safety and differentiated performance profile. Poster Details: Title: Efficacy Remaining at Time of Requested Retreatment Following Botulinum Toxin Treatment for Cervical Dystonia: Potential for a New Treatment Paradigm With DaxibotulinumtoxinA Authors and Affiliation: Aaron Ellenbogen, Robert A. Hauser, Atul Patel, Peter McAllister, Domenico Vitarella, Todd Gross, Rashid Kazerooni, Conor J. Gallagher, David A. Hollander, Michigan Institute for Neurological Disorders, Farmington Hills, MI, USA; University of South Florida, Tampa, FL, USA; Kansas City Bone & Joint Clinic, Overland Park, KS, USA; New England Institute for Neurology and Headache, Stamford, CT, USA; Revance Therapeutics, Inc., Nashville, TN, USA Title: Influence of Novel Formulation in DaxibotulinumtoxinA on Efficacy for Treatment of Cervical Dystonia Authors and Affiliation: Han Lee, André F. Batista, Conor J. Gallagher, The Permanente Medical Group, San Leandro, CA, USA; Revance Therapeutics, Inc., Nashville, TN, USA About Revance Revance is a biotechnology company setting the new standard in healthcare with innovative aesthetic and therapeutic offerings that enhance patient outcomes and physician experiences. Revance’s portfolio includes DAXXIFY® (DaxibotulinumtoxinA-lanm) for injection and the RHA® Collection of dermal fillers in the U.S. Revance has also partnered with Viatris Inc. to develop a biosimilar to onabotulinumtoxinA for injection and Shanghai Fosun Pharmaceutical to commercialize DAXXIFY® in China. Revance’s global headquarters and experience center is located in Nashville, Tennessee. Learn more at Revance.com, RevanceAesthetics.com, DAXXIFY.com, HCP.DAXXIFYCervicalDystonia.com, or connect with us on LinkedIn. “Revance”, the Revance logo, and DAXXIFY are registered trademarks of Revance Therapeutics, Inc. Resilient Hyaluronic Acid® and RHA are trademarks of TEOXANE SA. DAXXIFY® (daxibotulinumtoxinA-lanm) injection IMPORTANT SAFETY INFORMATION INDICATIONS DAXXIFY® (daxibotulinumtoxinA-lanm) injection is an acetylcholine release inhibitor and neuromuscular blocking agent indicated for the temporary improvement in the appearance of moderate to severe glabellar lines associated with corrugator and/or procerus muscle activity in adult patients and for the treatment of cervical dystonia in adults. WARNING: DISTANT SPREAD OF TOXIN EFFECT The effects of DAXXIFY® and all botulinum toxin products may spread from the area of injection to produce symptoms consistent with botulinum toxin effects. These symptoms have been reported hours to weeks after injection. Swallowing and breathing difficulties can be life threatening and there have been reports of death. DAXXIFY® is not approved for the treatment of spasticity or any conditions other than cervical dystonia and glabellar lines. IMPORTANT SAFETY INFORMATION Contraindications DAXXIFY® contraindications include hypersensitivity to any botulinum toxin preparation or any of the components in the formulation and infection at the injection site(s). Warnings and Precautions Please refer to Boxed Warning for Distant Spread of Toxin Effect. The potency units of DAXXIFY® are not interchangeable with preparations of other botulinum toxin products. Recommended dose and frequency of administration should not be exceeded. Patients should seek immediate medical attention if respiratory, speech or swallowing difficulties occur. Use caution when administering to patients with pre-existing cardiovascular disease. Concomitant neuromuscular disorders may exacerbate clinical effects of treatment. Adverse Reactions The most commonly observed adverse reactions are: Glabellar lines (≥1%): headache (6%), eyelid ptosis (2%) and facial paresis (1%). Cervical dystonia (≥5%): headache (9%), injection site pain (8%), injection site erythema (5%), muscular weakness (5%), and upper respiratory tract infection (5%). Drug Interactions Co-administration of DAXXIFY® and aminoglycoside antibiotics, anticholinergic agents or any other agents interfering with neuromuscular transmission or muscle relaxants should only be performed with caution as the effect of DAXXIFY® may be potentiated. The effect of administering different botulinum neurotoxins during course of treatment with DAXXIFY® is unknown. Use in Specific Populations DAXXIFY® is not recommended for use in children or pregnant women. Please see DAXXIFY® full Prescribing Information, including Boxed Warning and Medication Guide. To report side effects associated with DAXXIFY®, please visit safety.revance.com, or call 1-877-373-8669. You may also report side effects to the FDA at 1-800-FDA-1088 or visit . About DAXXIFY DAXXIFY (DaxibotulinumtoxinA-lanm) for injection is the first and only FDA approved long-lasting, peptide formulated neuromodulator product with approved indications in the U.S. for the temporary improvement of glabellar lines (frown lines) and for the treatment of cervical dystonia in adults. DAXXIFY is powered by Peptide Exchange Technology™, Revance's proprietary, synthetic, 35-amino-acid stabilizing excipient, and is developed free of human serum albumin or animal-based components.1-5 Manufactured in the U.S., DAXXIFY is the first true innovation in neuromodulator product formulation in over 30 years. About Cervical Dystonia According to the Dystonia Medical Research Foundation, cervical dystonia is a painful condition in which the neck muscles contract involuntarily, causing abnormal movements and awkward posture of the head and neck. The movements may be sustained (tonic), jerky (clonic), or a combination. Cervical dystonia (also referred to as spasmodic torticollis) may be primary (meaning that it is the only apparent neurological disorder, with or without a family history) or may be the result of secondary causes (such as physical trauma). First-line treatment for cervical dystonia is usually neuromodulator (botulinum toxin) injections, but additional treatments can include oral medications, surgery, and complementary therapies. Neuromodulators block the communication between the nerve and the muscle, relaxing the muscle, which alleviates abnormal involuntary movements and postures. Cervical dystonia can occur at any age, although most individuals first experience symptoms in middle age. The condition affects roughly 60,000 people in the United States. Forward-Looking Statements Any statements in this press release that are not statements of historical fact, including statements related to the potential benefits, safety, efficacy and duration (including treatment intervals) of DAXXIFY® for the treatment of cervical dystonia; our opportunity in aesthetics and therapeutics; the potential to set a new standard in healthcare; patient outcomes and physician experiences; development of an onobotulinumtoxinA biosimilar with our partner, Viatris; and commercialization of DAXXIFY® in China with our partner, Shanghai Fosun Pharmaceutical; constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. You should not rely upon forward-looking statements as predictions of future events. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee that the future results, levels of activity, performance, events, circumstances or achievements reflected in the forward-looking statements will ever be achieved or occur. Forward-looking statements are subject to risks and uncertainties that could cause actual results and the timing of events to differ materially from our expectations. These risks and uncertainties relate to, but are not limited to: our ability to obtain funding for our operations; the timing of capital expenditures; the accuracy of our estimates regarding expenses, revenues, capital requirements, supply chain and operational efficiencies; our financial performance and the economics of DAXXIFY and the RHA Collection of dermal fillers; our ability to comply with our debt obligations; the impact of macroeconomic factors on our manufacturing operations, supply chain, end user demand for our products, commercialization efforts, business operations, regulatory meetings, inspections and approvals, clinical trials and other aspects of our business and on the market; our ability to maintain approval of our products; our ability and the ability of our partners to manufacture supplies for DAXXIFY and our drug product candidates; our ability to acquire supplies of the RHA Collection of dermal fillers; the uncertain clinical development process; our ability to obtain, and the timing relating to, regulatory submissions and approvals with respect to our drug product candidates and third-party manufacturers; the risk that clinical trials may not have an effective design or generate positive results or that positive results would assure regulatory approval or commercial success; the applicability of clinical study results to actual outcomes; the rate and degree of economic benefit, safety, efficacy, duration, commercial acceptance, market, competition and/or size and growth potential of DAXXIFY, the RHA Collection of dermal fillers, and our drug product candidates, if approved; our ability to successfully commercialize DAXXIFY and to continue to successfully commercialize the RHA Collection of dermal fillers; the timing and cost of commercialization activities; securing or maintaining adequate coverage or reimbursement by third-party payers for DAXXIFY; the proper training and administration of our products by physicians and medical staff; our ability to maintain and gain acceptance from injectors and physicians in the use of DAXXIFY for aesthetic and therapeutic indications; our ability to strengthen professional partnerships; our ability to expand sales and marketing capabilities; the status of commercial collaborations; changes in and failures to comply with laws and regulations; our ability to continue obtaining and maintaining intellectual property protection for our products; the cost and our ability to defend ourselves in product liability, intellectual property, class action or other lawsuits; our ability to limit or mitigate cybersecurity incidents; the volatility of our stock price; and other risks. Detailed information regarding factors that may cause actual results to differ materially from the results expressed or implied by statements in this press release may be found in our periodic filings with the Securities and Exchange Commission (SEC), including factors described in the section entitled "Risk Factors" in our Form 10-K for the year ended December 31, 2023, filed with the SEC on February 28, 2024. The forward-looking statements in this press release speak only as of the date hereof. We disclaim any obligation to update these forward-looking statements. SOURCES Comella C, Ferreira JJ, Pain E, Azoulai M, Om S. Patient perspectives on the therapeutic pro botulinum neurotoxin type A in cervical dystonia. J Neurol 2020;268:903-912. Data on file. ASPEN CSR. Revance. Newark, CA: Revance Therapeutics, Inc., 2018. DAXXIFY. Prescribing Information. Revance Therapeutics, Inc, 2022. Fabi SG, Cohen JL, Green LJ, et al. DaxibotulinumtoxinA for Injection for the treatment of glabellar lines: efficacy results from SAKURA 3, a large, open label, phase 3 safety study. Dermatol Surg. 2020;47(1):48-54. Waugh JM, Lee J, Dake MD, Browne D. Nonclinical and clinical experiences with CPP-based self-assembling peptide systems in topical drug development. Methods Mol Biol. 2011;683:553-572.