Evolus to Present Phase 2 Interim Data from Jeuveau® “Extra-Strength” Dose for Extended Duration Study at 2023 IMCAS World Congress

Rhea-AI Summary

Evolus, Inc. (NASDAQ: EOLS) is set to present interim findings from a Phase 2 study on its neurotoxin product, Jeuveau (prabotulinumtoxinA-xvfs), at the 2023 International Master Course on Aging Science on January 28, 2023 in Paris. The presentation, led by Dr. Rui Avelar, will compare a new 'extra-strength' dose of Jeuveau to existing formulations and Botox for treating moderate to severe glabellar lines. The trial is expected to conclude in H1 2023, with final results to follow later this year. An investor webcast on January 30, 2023 will discuss these findings further.

Positive

• Presentation of interim findings from a Phase 2 study on Jeuveau highlights potential advancements in the neurotoxin market.
• The trial comparing an 'extra-strength' dose to standard doses may indicate enhanced efficacy.

Negative

• Risk of uncertainties associated with the Allergan/Medytox settlement could impact future operations.
• Dependence on approval and commercialization of Jeuveau presents inherent market risks.

• Oral presentation for longer duration formulation on Saturday, January 28, 2023
• Investor webcast to discuss findings on Monday, January 30, 2023

NEWPORT BEACH, Calif.--(BUSINESS WIRE)-- Evolus, Inc. (NASDAQ: EOLS), a performance beauty company with a customer-centric approach focused on delivering breakthrough products, will present interim findings from a Phase 2 study evaluating the safety, efficacy and duration of effect for its “extra-strength” dose of Jeuveau^® (prabotulinumtoxinA-xvfs) – the company’s flagship neurotoxin product – at the 2023 International Master Course on Aging Science (IMCAS) World Congress on January 28, 2023 in Paris.

The oral presentation, which will be presented by Rui Avelar, M.D., Chief Medical Officer and Head of Research and Development, Evolus, will report on the results of the “extra-strength” formulation using 40U of Jeuveau^® compared to the active controls, the approved 20U of Jeuveau^® and 20U of Botox^®, on the appearance of moderate to severe glabellar lines in adult patients using the 4-point Glabellar Line Scale. The trial is expected to be completed in the first half of 2023, and final results will be presented later this year.

Oral Presentation Information

Title: Prabotulinumtoxin longer duration formulation first interim analysis
Abstract Number: #120970
Time: 14:00 to 15:30 CET, Saturday, January 28, 2023
Location: Amphi Bleu - Level 2

Investor Webcast Information

Evolus will host a live webcast for investors on Monday, January 30th at 11:30 am Eastern to discuss the findings. To connect to the webcast, please access the link on the Events & Presentations page of our website at www.evolus.com. For audio-only access to the webcast, dial (877) 407-6184 (U.S.) or (201) 389-0877 (international). An archived copy of the webcast will available on our website later that day.

About Evolus, Inc.

Evolus (Nasdaq: EOLS) is a performance beauty company evolving the aesthetic neurotoxin market for the next generation of beauty consumers through its unique, customer-centric business model and innovative digital platform. Our mission is to become a global, multi-product aesthetics company based on our flagship product, Jeuveau^® (prabotulinumtoxinA-xvfs), the first and only neurotoxin dedicated exclusively to aesthetics and manufactured in a state-of-the-art facility using Hi-Pure™ technology. Visit us at www.evolus.com, and follow us on LinkedIn, Twitter, Instagram or Facebook.

IMPORTANT SAFETY INFORMATION FOR JEUVEAU^® (prabotulinumtoxinA-xvfs)

JEUVEAU 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 JEUVEAU:

• 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 pre-existing 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 and drooping eyelids, hoarseness or change or loss of voice, trouble saying words clearly, loss of bladder control, trouble breathing, trouble swallowing.

Do not use JEUVEAU if you: are allergic to any of the ingredients in JEUVEAU (see Medication Guide for ingredients); had an allergic reaction to any other botulinum toxin product such as rimabotulinumtoxinB (MYOBLOC®), onabotulinumtoxinA (BOTOX®/BOTOX® Cosmetic), abobotulinumtoxinA (DYSPORT®), or incobotulinumtoxinA (XEOMIN®); have a skin infection at the planned injection site; or are a child.

JEUVEAU dosing units are not the same as, or comparable to, any other botulinum.

Tell your healthcare provider 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 JEUVEAU.

Tell your healthcare provider about all your medical conditions, including: any side effects from botulinum toxin products, including dry eye; breathing, swallowing, bleeding, or heart problems; plans to have surgery; weakness of forehead muscles; drooping eyelids; have had surgery on your face; are pregnant or breastfeeding or plan to become pregnant or breastfeed (it is not known if JEUVEAU can harm your unborn baby or passes into breast milk).

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Using JEUVEAU with certain other medicines may cause serious side effects. Do not start any new medicines until you have told your healthcare provider that you have received JEUVEAU in the past.

Especially tell your healthcare provider if you: have received any other botulinum toxin product in the past and the last 4 months, and exactly which product you received (such as BOTOX, BOTOX Cosmetic, MYOBLOC, DYSPORT, or XEOMIN).

JEUVEAU may cause loss of strength or general muscle weakness, vision problems, or dizziness within hours to weeks of treatment with JEUVEAU. If this happens, do not drive a car, operate machinery, or do other dangerous activities.

JEUVEAU can cause other serious side effects including: allergic reactions such as itching, rash, red itchy welts, wheezing, trouble breathing, asthma symptoms, or dizziness or feeling faint. Tell your healthcare provider or get emergency medical help right away if you develop wheezing or trouble breathing, or if you feel dizzy or faint. Heart problems. Irregular heartbeat and heart attack that have caused death, have happened in some people who received botulinum toxin products. Eye problems such as dry eye, reduced blinking, and corneal problems. Tell your healthcare provider if you develop eye pain or irritation, sensitivity to light, or changes in your vision.

The most common side effects include: headache; eyelid drooping, upper respiratory tract infection, and increased white blood cell count.

APPROVED USE

JEUVEAU is a prescription medicine that is injected into muscles and used in adults for a short period of time (temporary) to improve the look of moderate to severe frown lines between the eyebrows (glabellar lines).

The risk information provided here is not complete. For more information about JEUVEAU, see the full Prescribing Information including BOXED WARNING, and Medication Guide, visit evolus.com or talk to your healthcare provider.

To report side effects associated with use of JEUVEAU, please call 1-877-EVOLUS1/1-877-386-5871. 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.

Exclusively licensed and manufactured for: Evolus, Inc., 520 Newport Center Drive, Suite 1200, Newport Beach, CA 92660

Forward-Looking Statements

This press release contains forward-looking statements as defined under the Private Securities Litigation Reform Act of 1995 that involve risks and uncertainties, including statements based on our current expectations, assumptions, estimates and projections about future events, our business, financial condition, results of operations and prospects, our industry and the regulatory environment in which we operate. Any statements contained herein that are not statements of historical facts may be deemed to be forward-looking statements. In some cases, you can identify forward-looking statements by terms such as “anticipate,” “believe,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “will,” “would” or the negative of those terms, or other comparable terms intended to identify statements about the future. The company’s forward-looking statements include, but are not limited to, statements related to the company’s expectations regarding the company’s ongoing clinical trial and related research and development activities.

The forward-looking statements included herein are subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied by the forward-looking statements. These risks and uncertainties, all of which are difficult or impossible to predict accurately and many of which are beyond our control, include, but are not limited to uncertainties associated with our ability to comply with the terms and conditions in the Allergan/Medytox Settlement Agreements, our ability to fund our future operations or obtain financing to fund our operations, the continued impact of COVID-19 or other outbreaks of contagious diseases on our business, unfavorable global economic conditions and the impact on consumer discretionary spending, uncertainties related to customer and consumer adoption of Jeuveau®, the efficiency and operability of our digital platform, competition and market dynamics, our ability to successfully launch and commercialize our products in new markets, our ability to successfully broaden our product portfolio, our ability to maintain regulatory approvals of Jeuveau® or obtain regulatory approvals for new product candidates or indications and other risks described in our filings with the Securities and Exchange Commission, including in the section entitled “Risk Factors” in our Quarterly Report on Form 10-Q for the quarter ended September 30, 2022 filed with the Securities and Exchange Commission on November 8, 2022. These filings can be accessed online at www.sec.gov. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Except as required by law, we undertake no obligation to update or revise any forward-looking statements to reflect new information, changed circumstances or unanticipated events. If we do update or revise one or more of these statements, investors and others should not conclude that we will make additional updates or corrections.

Jeuveau^® and Nuceiva^® are registered trademarks of Evolus, Inc.
Hi-Pure^™ is a trademark of Daewoong Pharmaceutical Co, Ltd.
BOTOX^® is a registered trademark of Allergan, Inc.

View source version on businesswire.com: https://www.businesswire.com/news/home/20230123005229/en/

Investor Contact:

David K. Erickson, Evolus, Inc.

Vice President, Investor Relations

Tel: 949-966-1798

Email: david.erickson@evolus.com

Media Contact:

Maura Siefring

Media Relations Lead

Tel: 215-837-8450

Email: Maura.Siefring@uncappedcommunications.com

Source: Evolus

FAQ

What are the interim findings from Evolus' Jeuveau Phase 2 study?

Evolus will present interim findings comparing the efficacy of a new 'extra-strength' dose of Jeuveau to standard dosages at the IMCAS on January 28, 2023.

When will the investor webcast take place for Evolus' study findings?

Evolus will host a live investor webcast on January 30, 2023, at 11:30 AM Eastern to discuss the findings.

What is the significance of the Jeuveau Phase 2 study?

The Phase 2 study aims to evaluate the safety and efficacy of a higher dosage of Jeuveau, which could enhance its market position.

What are the potential risks associated with Evolus' clinical trials?

The clinical trial results could impact the market acceptance of Jeuveau and are subject to regulatory and market uncertainties.