Evolus Successfully Completes Patient Enrollment in Phase II Clinical Study Evaluating “Extra-Strength” Dose of Jeuveau®

Rhea-AI Summary

Evolus, Inc. (NASDAQ: EOLS) has completed patient enrollment for a clinical study assessing an 'extra-strength' dosing option for its neurotoxin product, Jeuveau^® (prabotulinumtoxinA-xvfs). Expected interim results are due in the first half of 2023. The multicenter study involves 150 patients over 12 months and aims to evaluate the safety, efficacy, and duration of Jeuveau^® at 40 units compared to existing doses. The company anticipates that this new option could meet diverse patient needs and enhance treatment customization.

Positive

• Completion of patient enrollment in clinical study for an 'extra-strength' dose of Jeuveau^® showcases progress.
• Expected interim results in the first half of 2023 could boost investor confidence.
• Marketed exclusively for aesthetics, Jeuveau^® targets unmet needs in the beauty sector.

Negative

• Dependence on successful Phase II trial results for future market acceptance poses a risk.
• Potential regulatory hurdles remain a concern for the introduction of extra-strength dosing.

Program designed to offer consumers a new “Extra-Strength” dosing option

NEWPORT BEACH, Calif.--(BUSINESS WIRE)-- Evolus, Inc. (NASDAQ: EOLS), a performance beauty company with a customer-centric approach focused on delivering breakthrough products, has completed patient enrollment in its 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.

“Completing patient enrollment represents another important milestone for Evolus, and we remain on track to deliver interim results in the first half of 2023,” said Rui Avelar, M.D., Chief Medical Officer and Head of Research and Development, Evolus. “This study will help us to evaluate the safety, efficacy and the duration of effect of this increased dose. We believe that the precise nature of Jeuveau^® makes it especially well-suited for the treatment of glabellar lines at a higher dose, as local and distant spread of neurotoxins remains a key area of importance.”

The “Extra-Strength” Glabellar Line Study is a multicenter, double blind, randomized trial that is following 150 patients for up to 12 months at five study sites. The study includes two active controls – the currently approved 20 units of Jeuveau^® and 20 units of BOTOX^® Cosmetic – which will be compared to 40 units of Jeuveau^®. In addition to evaluating the safety, efficacy and duration of effect, this study will also help assess the potential clinical tradeoffs for patients when using the longer duration option.

“While our customers believe the original 20-unit dose will continue to comprise the majority of use, they are interested in an extra-strength dosing option of Jeuveau^® to further customize treatments and meet the diverse needs of a broader patient population,” said David Moatazedi, President and CEO, Evolus. “Evolus is uniquely positioned to capitalize on this opportunity because of our aesthetics-only business model and the precision of our product.”

Jeuveau^® is approved 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 safety and efficacy of Jeuveau^® was evaluated through the company’s TRANSPARENCY program, the largest head-to-head pivotal study versus BOTOX^® to date. The product is approved for sale in the U.S. under the brand name Jeuveau^® and in Canada under the brand name Nuceiva^®, which will launch in Europe beginning in the second half of 2022.

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.

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 the fiscal year ended December 31, 2021 filed with the Securities and Exchange Commission on March 3, 2022 and our Quarterly Report on Form 10-Q for the quarter ended March 31, 2022, filed with the SEC on May 10, 2022.. 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/20220712005405/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' clinical study for Jeuveau^®?

The study aims to evaluate the safety, efficacy, and duration of effect of an 'extra-strength' dosing option for Jeuveau^®.

When will the interim results of the Jeuveau^® study be released?

Interim results are expected in the first half of 2023.

How many patients are involved in the Jeuveau^® clinical study?

The clinical study involves 150 patients over a duration of up to 12 months.

How does the 'extra-strength' dosing compare to current dosing options?

The study compares 40 units of Jeuveau^® to the currently approved 20 units of Jeuveau^® and 20 units of BOTOX^®.

What implications could the study results have for the market?

Successful results could enhance the product profile of Jeuveau^® and expand treatment options for a broader patient demographic.