Prabotulinumtoxina-XVFS(Evolus, Inc.)

Evolus dermal filler, Evolysse™ Lift, met primary endpoint of non-inferiority and demonstrated superiority to Restylane-L at 6 months; Secondary endpoints for improvement in nasolabial fold severity showed statistically significant differences compared to Restylane-L at all measured timepoints for the entire 12-month study period Evolus dermal filler, Evolysse™ Smooth, met primary endpoint of non-inferiority and demonstrated superiority to Restylane-L at 6 months; Secondary endpoints for improvement in nasolabial fold severity showed statistically significant differences compared to Restylane-L at 6 and 9 months The safety profiles were similar between the two Evolysse™ dermal filler products and Restylane-L and there were no treatment-related serious adverse events On track to submit Premarket Approval (PMA) applications for the first two Evolysse™ dermal filler products with the FDA within the next 90 days NEWPORT BEACH, Calif.--(BUSINESS WIRE)-- Evolus, Inc. (NASDAQ: EOLS), a performance beauty company with a focus on building an aesthetic portfolio of consumer brands, today announced positive topline results from a U.S. pivotal nasolabial fold (NLF) study of dermal filler products Evolysse™ Lift and Smooth. Data were presented at the 2024 SCALE Meeting on May 17, 2024, in Nashville. “Achieving positive topline results in our NLF study is a pivotal step supporting the upcoming submission of our Premarket Approval application for the U.S. launch of our dermal filler lines. Complementing our flagship neurotoxin Jeuveau® – the fastest growing neurotoxin in the U.S. for the past three years1 – our Evolysse™ line of dermal fillers expands our total addressable market by 78%,” said David Moatazedi, President and Chief Executive Officer. “Built on the earlier success of the European head-to-head trial, the consistency of results from this pivotal trial for Evolysse™ Lift and Smooth were impressive when compared to the previously shared European nasolabial fold data,” said Dr. Rui Avelar, MD, Chief Medical Officer and Head of R&D. “The R&D team remains on track to complete and submit the PMA to the FDA within the next 90 days and this data increases our confidence in the submission.” “As an investigator in this pivotal trial, I had first-hand experience in treating patients with the new Evolysse™ HA filler line that is manufactured using a novel “Cold Technology” process which is aimed at preserving the natural structure of the HA molecule,” said Dr. Steven Dayan, MD. “Clinically, I found the product to be precise and I could treat patients to optimal correction. I was also struck by the fact that despite using the same amount of product between the treatment and control, there seems to be more of a difference in the correction when looking at the Evolysse™ treatment arm.” Study Design The U.S. NLF pivotal study was a multicenter, blinded, split face, controlled, non-inferiority design. Patients were followed for 12 months from initial treatment. A total of 140 patients were enrolled and divided evenly across two investigational arms. Patients were randomized to receive Evolysse™ Lift or Evolysse™ Smooth in one NLF and Restylane-L in the contralateral NLF. This split face design allowed each individual patient to experience one of the Evolysse™ fillers and the control at the same time. The 6-month primary endpoint measured the change in NLF severity from baseline and was assessed by a blinded independent photographic review panel using a validated 5-point nasolabial scale. Results The Evolysse™ Lift vs Restylane-L arm met the primary endpoint of non-inferiority and demonstrated superiority, with a mean NLF severity score difference of -0.3 (95% CI: -0.500, -0.032, non-inferiority margin 0.5) and corresponding p-value of 0.03. As a secondary endpoint, the mean grade change in the NLF severity, as assessed by the blinded, live evaluator demonstrated a statistically significant difference (p<0.05) at all timepoints from 6 weeks to 12 months between Evolysse™ Lift and the control. The Evolysse™ Smooth vs Restylane-L arm also met the primary endpoint of non-inferiority and demonstrated superiority, with a mean NLF severity score difference of -0.2 (95% CI: -0.416, -0.019, non-inferiority margin 0.5) and corresponding p-value of 0.02. As a secondary endpoint, the mean grade change in the NLF severity, as assessed by the blinded, live evaluator demonstrated a statistically significant difference (p<0.05) at 6 and 9 months between Evolysse™ Smooth and the control. The safety profiles were similar between the two Evolysse™ dermal filler products compared to their respective controls and there were no treatment-related serious adverse events. Evolus remains on track to submit Premarket Approval (PMA) applications for the first two Evolysse™ dermal filler products with the FDA within the next 90 days. The Evolysse™ Lift filler will be positioned as the most versatile and highest use filler in the product line. The Evolysse™ Smooth filler is a softer product than Lift, providing additional versatility. 1 Measured by comparing year-over-year revenue growth of each aesthetic neurotoxin on the market for the entirety of each comparable year. About Evolus, Inc. Evolus (NASDAQ: EOLS) is a global 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. Evolus is expanding its product portfolio having entered into a definitive agreement to be the exclusive U.S. distributor of Evolysse™, and the exclusive distributor in Europe of Estyme®, a line of unique dermal fillers currently in late-stage development. Visit us at , and follow us on LinkedIn, X, Instagram or Facebook. 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 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 or current facts are 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 anticipated product launches; market size, conditions and consumer demand; and the timing of regulatory submissions and approvals. The forward-looking statements included herein are based on our current expectations, assumptions, estimates and projections, which we believe to be reasonable, and 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 Medytox Settlement Agreements, our ability to fund our future operations or obtain financing to fund our operations, unfavorable global economic conditions and the impact on consumer discretionary spending, uncertainties related to customer and consumer adoption of Jeuveau® and Evolysse™, the efficiency and operability of our digital platform, competition and market dynamics, our ability to successfully launch and commercialize our products in new markets, including the Evolysse™ dermal filler product line in the U.S., our ability to maintain regulatory approvals of Jeuveau® or obtain regulatory approvals for new product candidates or indications, our reliance on Symatese to achieve regulatory approval for the Evolysse™ dermal filler product line in the U.S., and other risks described in our filings with the Securities and Exchange Commission, including in the section entitled “Risk Factors” in our Annual Report on Form 10-K Form and our Quarterly Report on Form 10-Q for the quarter ended March 31, 2024 filed with the Securities and Exchange Commission on May 7, 2024. These filings can be accessed online at . 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 and Evolysse™ is a trademark of Evolus, Inc. Hi-Pure™ is a trademark of Daewoong Pharmaceutical Co, Ltd. Estyme® is a trademark of Symatese Aesthetics S.A.S. Restylane® is a trademark of Galderma S.A.

– Ongoing analysis of interim data from the Phase 2 study of ABP-450 in chronic migraine, which did not achieve its primary or secondary endpoints – – Evaluating next-steps across the Company’s late-stage clinical pipeline for ABP-450 that targets multiple indications – IRVINE, Calif., May 14, 2024 (GLOBE NEWSWIRE) -- AEON Biopharma, Inc. (“AEON” or the “Company”) (NYSE: AEON), a clinical-stage biopharmaceutical company focused on developing a proprietary botulinum toxin complex for the treatment of multiple debilitating medical conditions, announced financial results for the first quarter ended March 31, 2024, and provided a business update. “We continue to believe in our development pipeline for ABP-450, which targets a number of indications that have well-founded scientific rationale to pursue in early- and late-stage clinical trials. Several of the late-stage clinical programs are candidates to advance into the next phase of clinical development,” commented Marc Forth, AEON’s President and Chief Executive Officer. “We look forward to keeping you apprised of our progress and updated timelines across the development strategy for our pipeline.” Recent Clinical and Corporate Highlights Phase 2 study of ABP-450 in episodic and chronic migraine: Chronic Migraine - Interim Analysis: The topline interim analysis did not achieve its primary or secondary endpoints. The Company is continuing its analysis of interim data from the study. The Phase 2 randomized, double-blind, placebo-controlled study is evaluating the efficacy and safety of ABP-450 for the prevention of chronic migraine in adults who suffer from 15 or more headache days per month and at least 8 migraine days per month. The study has enrolled a total of 492 patients across approximately 50 sites in the United States, Canada and Australia.Episodic Migraine End-of-Phase 2 Meeting with U.S. FDA: In the first quarter of 2024, the Company held a productive end-of-Phase 2 (EOP2) meeting with the U.S. Food and Drug Administration to present the Company’s Phase 2 episodic migraine study results, which demonstrated a favorable safety profile for patients with episodic migraine and achieved key prespecified secondary endpoints, although it did not statistically separate from placebo with respect to the primary endpoint. The meeting resulted in a preliminary alignment on the design and endpoints for the proposed pivotal Phase 3 trial. Completed $15 Million Private Placement Agreements In April 2024, the Company received the second and final installment from its definitive agreements relating to a private placement of $15 million aggregate principal amount of senior secured convertible notes (the “Notes”) with its strategic partner, Daewoong Pharmaceutical Co., LTD (“Daewoong”). Proceeds from the private placement are being used for general working capital purposes.In connection with the receipt of the final installment of the Notes, Seongsoo (Shawn) Park was appointed to the Company’s Board of Directors as Daewoong’s representative. 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, with an initial focus on the neurosciences market. 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. 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 the closing of each installment of the Private Placement, AEON’s expected capital resources and liquidity needs and the anticipated timing of AEON’s clinical results 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, including with respect to potential obligations pursuant to the forward purchase agreements; (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; and (vi) 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 AEON BIOPHARMA, INC.CONDENSED CONSOLIDATED BALANCE SHEETS(in thousands, except share data and par value amounts) Successor Successor March 31, December 31, 2024 2023 (Unaudited) ASSETS Current assets: Cash and cash equivalents$1,558 $5,158 Prepaid expenses and other current assets 940 1,064 Total current assets 2,498 6,222 Property and equipment, net 307 332 Operating lease right-of-use asset 198 262 Other assets 29 29 Total assets$3,032 $6,845 LIABILITIES AND STOCKHOLDERS' DEFICIT Current liabilities: Accounts payable$6,523 $3,388 Accrued clinical trials expenses 984 5,128 Accrued compensation 1,338 943 Forward purchase agreements liquidated damages 3,000 — Other accrued expenses 4,112 3,590 Total current liabilities 15,957 13,049 Convertible notes at fair value, including related party amount of $5,087 and $0, at March 31, 2024 and December 31, 2023, respectively 5,087 — Warrant liability 12,000 1,447 Contingent consideration liability 168,119 104,350 Embedded forward purchase agreements and derivative liabilities 250 41,043 Total liabilities 201,413 159,889 Commitments and contingencies Stockholders’ Deficit: Class A common stock, $0.0001 par value; 500,000,000 shares authorized at March 31, 2024 and December 31, 2023, and 38,120,288 and 37,159,600 shares issued and outstanding at March 31, 2024 and December 31, 2023, respectively 4 4 Additional paid-in capital 393,235 381,264 Subscription receivables — (60,710)Accumulated deficit (591,620) (473,602)Total stockholders' deficit (198,381) (153,044)Total liabilities and stockholders' deficit$3,032 $6,845 AEON BIOPHARMA, INC.CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS(in thousands, except share and per share data) Three Months Ended March 31, 2024 2023 Successor PredecessorOperating expenses: Selling, general and administrative$4,649 $3,841 Research and development 5,732 9,205 Change in fair value of contingent consideration 63,769 — Total operating costs and expenses 74,150 13,046 Loss from operations (74,150) (13,046)Other (loss) income: Change in fair value of convertible notes (87) (4,657)Change in fair value of warrants (20,903) — Loss on embedded forward purchase agreements and derivative liabilities, net (22,917) — Other income, net 39 64 Total other loss, net (43,868) (4,593)Loss before taxes (118,018) (17,639)Income taxes — — Net loss and comprehensive loss$(118,018) $(17,639)Basic and diluted net loss per share$(3.17) $(0.13)Weighted average shares of common stock outstanding used to compute basic and diluted net loss per share 37,268,074 138,825,356 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”). The condensed consolidated financial statements include the accounts of the Company and its controlled subsidiaries. On July 21, 2023, AEON completed the Merger with AEON Biopharma Sub, Inc. (“Old AEON”), with Old AEON surviving the merger as a wholly-owned subsidiary of the Company, the accounting acquirer. The transaction has been accounted for as a forward merger asset acquisition. Unless the context otherwise requires, the “Company,” for periods prior to the close of the Merger, refers to Old AEON, currently AEON Biopharma Sub, Inc. (“Predecessor”), and for the periods after the close of the Merger, refers to AEON Biopharma, Inc., including AEON Biopharma Sub, Inc. (“Successor”). As a result of the Merger, the results of operations, financial position and cash flows of the Predecessor and Successor are not directly comparable. AEON Biopharma Sub, Inc. was deemed to be the Predecessor entity. Accordingly, the historical financial statements of AEON Biopharma Sub, Inc. became the historical financial statements of the combined Company, upon the consummation of the Merger. As a result, the financial statements included in this release reflect (i) the historical operating results of AEON Biopharma Sub, Inc. prior to the Merger and (ii) the combined results of the Company, including AEON Biopharma Sub, Inc., following the closing of the Merger. The accompanying financial statements include a Predecessor period for the three months ended March 31, 2023, and a Successor period for the three months ended March 31, 2024. A black line between the Successor and Predecessor periods has been placed in the condensed consolidated financial statements and in the tables to the notes to the condensed consolidated financial statements to highlight the lack of comparability between these two periods.