Botulinum toxin(UroGen Pharma Ltd.)

NEWS RELEASE: Merz Therapeutics and S3 Connected Health Pioneer New Digital Health Solution, iFlexo, for People Living with Post-Stroke Spasticity Dublin/Frankfurt — Merz Therapeutics launches iFlexo, a personalized digital solution aimed at enhancing rehabilitation for people with post-stroke spasticity as part of its ongoing commitment to supporting stroke survivors. The app, developed in collaboration with S3 Connected Health, provides targeted exercises and rehabilitation programs specifically aimed at improving mobility for those with mild to moderate spasticity. By offering guided routines, iFlexo aims to help stroke survivors regain independence and improve their overall quality of life. Merz Therapeutics is the first and only neurotoxins pharmaceutical company to offer a platform to support self-rehabilitation. iFlexo, developed and operated on S3 Connected Health’s digital health platform Affinial, was released in August 2024 and is available for iOS and Android in France. Developing iFlexo on Affinial enabled the creation of a differentiated user experience optimized for post-stroke patients. An accelerated time to market of just five months was achieved thanks to Affinial’s range of pre-built, customizable digital health services. The Affinial platform enables iFlexo to scale and evolve by addressing current and future compliance, legal, cybersecurity, and regulatory requirements. During the pilot stage in France, it gained significant interest from patients, clinicians, and key opinion leaders. Dr. Alexandre Bertholon, Physical Medicine & Rehabilitation at Le Clos Champirol, says: “iFlexo is a promising solution in physical rehabilitation, offering a much-needed response to the current challenges in the field. It enables patients to engage in self-rehabilitation at home, focusing on their personal goals. This platform not only supports patients but also enhances efficiency for healthcare professionals by optimizing and extending the results of rehabilitation. It demonstrates how new solutions can improve patient outcomes and make care more effective.” Up to one-third of stroke survivors experience spasticity, a condition that can severely limit their ability to perform everyday tasks, often leaving them reliant on others.[1] For these individuals, personalized botulinum neurotoxin injection therapy as part of a multimodal approach can improve muscle tone and consequently patient’s mobility and quality of life. [2] Merz Therapeutics and S3 Connected Health are committed to providing better outcomes for more patients and are currently working on expanding the solution to more countries, starting in the coming months. [1] Ali, A., McCarthy, A.D., Reeves, M. et al. Sheffield Adaptive Patterned Electrical Stimulation (SHAPES) Therapy for Post Stroke Arm spasticity: study protocol for a 3-arm, a partially blinded, randomised controlled trial. BMC Neurol 24, 437 (2024). [2] Otero-Luis I, Martinez-Rodrigo A, Cavero-Redondo I, Moreno-Herráiz N, Martínez-García I, Saz-Lara A. Effect of Botulinum Toxin Injections in the Treatment of Spasticity of Different Etiologies: An Umbrella Review. Pharmaceuticals. 2024; 17(3):310. Merz Therapeutics Merz Therapeutics GmbH is dedicated to improving the lives of patients around the world. With its relentless research, development, and culture of innovation, Merz Therapeutics strives to serve unmet patient needs and realize better outcomes. Merz Therapeutics seeks to address the unique needs of people who suffer from movement disorders, neurological conditions, liver disease, and other health conditions that severely impact patients’ quality of life. Merz Therapeutics is headquartered in Frankfurt am Main, Germany and is represented in more than 90 countries, with a North America affiliate based in Raleigh, North Carolina. Merz Therapeutics GmbH is part of the Merz Group, a privately held, family-owned company that has dedicated 115 years to developing innovations that serve unmet patient and customer needs. For more information, please visit: S3 Connected Health S3 Connected Health is the specialist digital health partner for life science companies, developing regulated digital health solutions that improve the lives of people with acute and chronic conditions. It has delivered award-winning, regulatory-compliant solutions across 20 therapy areas and in more than 50 countries. The company’s scalable and secure solutions improve disease management, differentiate pharmaceutical products and deliver new therapeutic approaches. Affinial, S3 Connected Health’s digital health platform, offers partners the opportunity to develop customized digital health solutions tailored to specific patient, device or disease needs. The platform’s pre-built services provide best practice implementation to ensure successful solution adoption and an accelerated time-to-market. For more information, please visit: The opinions expressed in this news release are the author’s only and do not necessarily reflect those of Medical Design & Outsourcing or its employees.

– Held biosimilar advisory meeting with FDA in Q3 2024, and aligned on next steps for a 351(k) regulatory pathway to approval for ABP-450 (prabotulinumtoxinA) as a biosimilar utilizing BOTOX® (onabotulinumtoxinA) as the reference product – – Plan to initiate comparative analytical studies anticipated in Q4 2024 subject to available resources – – 351(k) regulatory pathway offers potential to bring ABP-450 to the U.S. market under a single approval for all of BOTOX’s currently approved and future therapeutic indications – IRVINE, Calif., Nov. 13, 2024 (GLOBE NEWSWIRE) -- AEON Biopharma, Inc. (“AEON” or the “Company”) (NYSE: AEON), a clinical-stage biopharmaceutical company focused on developing a botulinum toxin complex for the treatment of multiple therapeutic indications, announced financial results for the third quarter ended September 30, 2024, and provided a business update. “We are making significant progress advancing our biosimilar development program for ABP-450 under the 351(K) regulatory pathway utilizing BOTOX as the reference product. The next key step in this program is the initiation of our planned primary comparative analytical studies, which are scheduled to start in the coming weeks. Once we have the data from these studies, we can complete the primary comparative analytical assessment, which the FDA will use to evaluate and determine the next steps for the program. This is an exciting time for the company as we work towards executing a regulatory pathway that could allow us to bring ABP-450 to the U.S. market for all of BOTOX’s currently approved and future therapeutic indications under a single FDA approval,” commented Marc Forth, AEON’s President and Chief Executive Officer. “As we evaluate our path forward, the single biggest limitation for the Company remains our current capital resources. We are evaluating all available options that would allow the AEON team to execute the current regulatory strategy for ABP-450.” Recent Clinical and Corporate Highlights Development plan for ABP-450 utilizing 351(k) regulatory pathway for biosimilars - Based on the formal minutes received from a Biosimilar Initial Advisory (BIA) Meeting in the third quarter of 2024 with the U.S. Food and Drug Administration (FDA) for ABP-450 (prabotulinumtoxinA) injection as a biosimilar utilizing BOTOX® (onabotulinumtoxinA) as the reference product, the Company believes it is aligned with the FDA on the initial key requirements in the development 351(k) regulatory pathway and next steps. Actively planning primary comparative analytical studies to fulfill the standard regulatory requirements for a comparative analytical assessment (CAA), which are expected to commence in the fourth quarter of 2024, subject to securing capital resources.Plan to hold a Biosimilar Biological Product Development (BPD) Type 2 meeting with FDA in 2025 to discuss the outcome from these studies and determine the next steps in development. 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. The product is approved as a biosimilar in Mexico and India. 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 meetings with the FDA, the timing of primary comparative analytical studies, and potential determination that ABP-450 is highly similar to the reference product for currently approved and future therapeutic indications 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; (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) September 30, December 31, 2024 2023 (Unaudited) ASSETS Current assets: Cash and cash equivalents $537 $5,158 Prepaid expenses and other current assets 1,834 1,064 Total current assets 2,371 6,222 Property and equipment, net 258 332 Operating lease right-of-use asset 1,346 262 Other assets 29 29 Total assets $4,004 $6,845 LIABILITIES AND STOCKHOLDERS' DEFICIT Current liabilities: Accounts payable $4,630 $3,388 Accrued clinical trials expenses 1,373 5,128 Accrued compensation 1,563 943 Other accrued expenses 3,160 3,590 Total current liabilities 10,726 13,049 Convertible notes at fair value, including related party amount of $15,170 and $0, at September 30, 2024 and December 31, 2023, respectively 15,170 — Operating lease liability 1,204 — Warrant liability 1,844 1,447 Contingent consideration liability 6,886 104,350 Embedded forward purchase agreements and derivative liabilities 264 41,043 Total liabilities 36,094 159,889 Commitments and contingencies Stockholders’ Deficit: Class A common stock, $0.0001 par value; 500,000,000 shares authorized at September 30, 2024 and December 31, 2023, and 39,587,630 and 37,159,600 shares issued and outstanding at September 30, 2024 and December 31, 2023, respectively 4 4 Additional paid-in capital 401,585 381,264 Subscription receivables — (60,710) Accumulated deficit (433,679) (473,602) Total stockholders' deficit (32,090) (153,044) Total liabilities and stockholders' deficit $4,004 $6,845 AEON BIOPHARMA, INC.CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE (LOSS) INCOME(in thousands, except share and per share data) Three Months Ended Nine Months Ended September 30, September 30, 2024 2023 2024 2023 Successor Successor July 22 to September 30 Predecessor July 1 to July 21 Successor Successor July 22 to September 30 Predecessor January 1 to July 21Operating expenses: Selling, general and administrative $3,044 $5,265 $1,055 $11,014 $5,265 $9,841 Research and development 972 6,388 1,573 11,144 6,388 19,803 Acquired in-process research and development — 348,000 — — 348,000 — Change in fair value of contingent consideration — (75,939) — (97,464) (75,939) — Total operating costs and expenses 4,016 283,714 2,628 (75,306) 283,714 29,644 (Loss) income from operations (4,016) (283,714) (2,628) 75,306 (283,714) (29,644)Other (loss) income: Change in fair value of convertible notes (1,878) — (13,249) (170) — (19,359)Change in fair value of warrants (377) 1,593 — (15,376) 1,593 — Income (loss) on embedded forward purchase agreements and derivative liabilities, net 81 (15,776) (11,789) (19,931) (15,776) (11,789)Other income, net 19 186 5 94 186 114 Total other loss, net (2,155) (13,997) (25,033) (35,383) (13,997) (31,034)(Loss) income before taxes (6,171) (297,711) (27,661) 39,923 (297,711) (60,678)Income taxes — — — — — — Net (loss) income $(6,171) $(297,711) $(27,661) $39,923 $(297,711) $(60,678)Basic net (loss) income per share $(0.16) $(8.01) $(0.20) $1.04 $(8.01) $(0.44)Diluted net (loss) income per share $(0.16) $(8.01) $(0.20) $0.97 $(8.01) $(0.44)Weighted average shares of common stock outstanding used to compute basic net (loss) income per share 39,515,292 37,159,600 138,848,177 38,545,882 37,159,600 138,848,177 Weighted average shares of common stock outstanding used to compute diluted net (loss) income per share 39,515,292 37,159,600 138,848,177 41,318,831 37,159,600 138,848,177 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 Predecessor periods for the period from January 1, 2023 to July 21, 2023 and July 1, 2023 to July 21, 2023, and Successor periods for the three and nine months ended September 30, 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 periods.