Evolus Announces First Patient Enrolled in Phase II Clinical Study Evaluating “Extra-Strength” Dose of Jeuveau®

Rhea-AI Summary

Evolus, Inc. (NASDAQ: EOLS) has enrolled its first patient in a pivotal clinical study assessing an ‘extra-strength’ dose of Jeuveau^® (prabotulinumtoxinA-xvfs), designed for aesthetic use. This multicenter, double-blind trial will involve 150 patients and compare the efficacy of 40 units of Jeuveau^® against the standard 20-unit doses of Jeuveau^® and BOTOX^® Cosmetic. The company anticipates study completion in the first half of 2023, aiming to address a need in the aesthetic market, as clinicians have expressed interest in a stronger dosage option.

Positive

• Enrollment of the first patient marks a critical milestone for Evolus.
• Potential to fulfill an unmet need in the aesthetic neurotoxin market.
• Evolus is well-positioned to capitalize on the desire for an 'extra-strength' Jeuveau^® dose.

Negative

• Risks associated with the completion of the Phase II clinical trial.
• Dependence on FDA approval for commercialization of the 'extra-strength' product.
• Uncertainties related to customer adoption and overall market dynamics.

NEWPORT BEACH, Calif.--(BUSINESS WIRE)-- Evolus, Inc. (NASDAQ: EOLS), a performance beauty company with a customer-centric approach focused on delivering breakthrough products, has enrolled its first patient in a clinical study evaluating an “extra-strength” dose for extended duration of Jeuveau^® (prabotulinumtoxinA-xvfs), its flagship neurotoxin product and the first and only neurotoxin dedicated exclusively to aesthetics.

The “Extra-Strength” Glabellar Line Study is a multicenter, double blind, randomized trial that will follow 150 patients for up to 12 months. The study will include two active controls—the currently approved 20 units of Jeuveau^® and 20 units of BOTOX^® Cosmetic—which will be compared to 40 units of “extra-strength” Jeuveau^®. Five study sites have been selected to participate. Evolus anticipates completing the study in the first half of 2023.

“Enrolling the first patient in the ‘extra-strength’ trial marks an important milestone for Evolus—we are now one step closer to the possibility of fulfilling an unmet need in the aesthetic neurotoxin segment,” said David Moatazedi, President and CEO, Evolus. “While many of our customers believe the original strength, 20-unit dose of Jeuveau^® will comprise a majority of their use, clinicians have voiced the desire for an ‘extra-strength’ dose option as well. As a cash pay, aesthetics-only company, Evolus is uniquely positioned to capitalize on this opportunity and meet the needs of our customers.”

Jeuveau^® is used for the temporary improvement in the appearance of moderate to severe vertical lines between the eyebrows seen at maximum frown (glabellar lines) in adults below 65 years of age. The largest head-to-head pivotal study versus BOTOX^® to date evaluated the safety and efficacy of Jeuveau^®, enrolling more than 2,100 patients as part of Evolus’ TRANSPARENCY clinical development program. The product is approved for sale in the United States under the brand name Jeuveau^® and in Canada under the brand name Nuceiva^®. The company plans to launch Nuceiva^® in Europe in the second half of 2022.

About Evolus, Inc.

Evolus (Nasdaq: EOLS) is a performance beauty company with a customer-centric approach to delivering breakthrough products. Approved in 2019 by the U.S. Food and Drug Administration, Jeuveau^® (prabotulinumtoxinA-xvfs) is the first and only neurotoxin dedicated exclusively to aesthetics and manufactured in a state-of-the-art facility using Hi-Pure™ technology. Jeuveau^® is powered by Evolus’ unique technology platform and is designed to transform the aesthetic market by eliminating the friction points existing for customers today. Visit us at www.evolus.com and follow us on LinkedIn, Twitter, Instagram or Facebook.

This press release contains forward-looking statements as defined under the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical fact, are statements that could be deemed forward-looking statements, including statements that relate to the status of regulatory processes, future plans, events, prospects or performance and statements containing the words “plans,” “expects,” “believes,” “strategy,” “opportunity,” “anticipates,” “outlook,” “designed,” or other forms of these words or similar expressions, although not all forward-looking statements contain these identifying words. The company’s forward-looking statements include, but are not limited to, statements related to the company’s prospects, customer and consumer acceptance of an “extra strength” product, study milestones , regulatory approvals and commercial launch.

Forward-looking statements involve risks and uncertainties that could cause actual results or experiences to differ materially from those expressed or implied by the forward-looking statements. Factors that could cause actual results or experience to differ materially from that expressed or implied by the forward-looking statements include the ability to successfully complete the Phase II clinical trial, ability to achieve FDA approval and ultimate commercial acceptability and pricing for an “extra strength” Jeuveau^® dose, uncertainties associated with our ability to address all of our losses, costs, expenses, liabilities and damages resulting from the settlement agreement with Daewoong and our ability to comply with the terms and conditions in the Allergan/Medytox Settlement Agreements, the continued impact of COVID-19 on our business and the economy generally, uncertainties related to customer and consumer adoption of Jeuveau^®, the efficiency and operability of our digital platform, competition and market dynamics, and our ability to maintain regulatory approval of Jeuveau^® and other risks described in Evolus’ filings with the Securities and Exchange Commission, including in the section entitled “Risk Factors” in our Annual Report on Form 10-K for year ended December 31, 2021 that was filed with the Securities and Exchange Commission. These filings can be accessed online at www.sec.gov. Readers are cautioned not to place undue reliance on forward-looking statements concerning timing of clinical results and outcome of the trial. Except as required by law, Evolus undertakes no obligation to update or revise any forward-looking statements to reflect new information, changed circumstances or unanticipated events. If the company does update or revise one or more of these statements, investors and others should not conclude that the company 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/20220331005309/en/

Investor Contact:

David K. Erickson

Vice President, Investor Relations

Tel: 949-966-1798

Email: david.erickson@evolus.com

Media Contact:

Andrea Sampson

President/CEO, Sampson Public Relations Group

Tel: 562-304-0301

Email: asampson@sampsonprgroup.com

Source: Evolus

FAQ

What is the goal of Evolus’ ‘extra-strength’ Jeuveau study?

The study aims to evaluate the efficacy and safety of an ‘extra-strength’ dose of Jeuveau^® for improved aesthetic results.

When does Evolus expect to complete the clinical trial for Jeuveau?

Evolus anticipates completing the study in the first half of 2023.

How many patients will participate in the Evolus clinical study?

The study will enroll 150 patients over the course of the trial.

What will be compared in the clinical study for Jeuveau?

The study compares 40 units of ‘extra-strength’ Jeuveau^® against 20 units of Jeuveau^® and BOTOX^® Cosmetic.

What are the potential market implications of the ‘extra-strength’ Jeuveau study?

Successful outcomes could expand Evolus' market presence and meet the increasing demand for stronger aesthetic neurotoxin options.