Onabotulinumtoxin A

– Announced positive initial comparative analytical results, confirming identical amino-acid sequencing and highly similar functional characteristics to BOTOX ® – – Reported positive FDA BPD Type 2a meeting, with FDA feedback providing a clear framework for advancing the comparative analytical plan for ABP-450 biosimilar program – – Strengthened balance sheet through $6 million PIPE financing and Daewoong note exchange, reducing outstanding debt by more than 90% – – Appointed John Bencich as Chief Financial Officer, adding significant capital markets and strategic leadership experience – IRVINE, Calif., March 30, 2026 (GLOBE NEWSWIRE) -- AEON Biopharma, Inc. (“AEON” or the “Company”) (NYSE American: AEON), a biopharmaceutical company advancing ABP-450 (prabotulinumtoxinA) as a biosimilar to BOTOX ® (onabotulinumtoxinA) to achieve full-label U.S. market entry, today announced its financial results for the full year ended December 31, 2025, and provided a business update. “We’ve advanced the ABP-450 program with a positive FDA meeting and supportive initial comparative analytical results that reinforce our biosimilar development strategy,” said Robert Bancroft, President and Chief Executive Officer of AEON. “The Agency’s feedback supports AEON’s proposed framework for completing our analytical program and preparing for our next regulatory interaction. At the same time, we strengthened our balance sheet through our recent financing and note exchange, positioning the Company to execute this next stage of development. With strong foundational biosimilarity data in hand, we are entering the next development phase with greater scientific, regulatory, and financial clarity, and remain confident in our strategy to pursue full-label U.S. market entry for ABP-450.” Recent Clinical and Corporate Highlights Positive Biosimilarity Results In November 2025, AEON reported positive initial comparative data for ABP-450, its proposed biosimilar to BOTOX ® . These initial analytical results confirmed identical amino-acid sequencing and highly similar functional characteristics to BOTOX ® . These analytical results were included in the package submitted to the FDA ahead of AEON’s BPD Type 2a meeting. Liquid chromatography/mass spectrometry (LC/MS) analysis of over 3,400 amino acids demonstrated that the primary structure of ABP-450 exhibited a 100% sequence match to BOTOX ® , based on sequence coverage of 93–99% across all five proteins comprising the 900 kDa botulinum toxin type A complex. Functional analyses demonstrated initial similarity in potency (using LD 50 and cell-based potency assays), composition (vial-to-vial comparability analyzed with ELISA), and enzymatic activity (functional cleavage of SNAP-25 consistent with mechanism of action). The Company continues to build on this analytical biosimilarity foundation and expects the majority of its analytical comparability program to be completed in 2026. Announced Constructive FDA Feedback Following January 2026 Biosimilar Biological Product Development (BPD) Type 2a Meeting AEON reported that the U.S. Food and Drug Administration (“FDA” or the “Agency”) reviewed the Company’s proposed analytical similarity strategy under the 351(k) biosimilar pathway and noted that AEON’s analytical methodologies appeared reasonable to support advancement of the program toward a comprehensive analytical similarity package. The Company believes the FDA’s feedback provides a clear framework for the remaining analytical components of its biosimilar development program and plans to complete the majority of its analytical comparability program in 2026. AEON currently plans to request a BPD Type 2b meeting in 2026 to discuss the next phase of the development program to support approval of ABP-450 as a biosimilar to BOTOX ® across all approved therapeutic indications. Strategic PIPE Financing and Note Exchange AEON announced complementary transactions through a $6 million PIPE financing and a Daewoong Pharmaceutical note exchange – which, together, strengthens AEON’s balance sheet and reduces outstanding debt by more than 90%. Appointed John Bencich as Chief Financial Officer In March 2026, the Company announced the appointment of John Bencich as Chief Financial Officer. Mr. Bencich joins AEON with more than 25 years of leadership experience spanning corporate strategy, capital market transactions, and business development across emerging growth and publicly traded companies. Abstract Accepted for Presentation at 2026 American Academy of Neurology (AAN) Annual Meeting Also in March 2026, AEON announced a poster presentation at the 2026 American Academy of Neurology (AAN) Annual Meeting, taking place April 18-22, 2026, in Chicago, IL, titled Establishing Primary Structure Comparability Between ABP-450 (prabotulinumtoxinA) and OnabotulinumtoxinA (BOTOX ® ) to Support Biosimilarity. Liquidity and Capital Resources The Company reported cash and cash equivalents of $3.0 million as of December 31, 2025, which does not include the $4.2 million of proceeds received upon the second closing of the PIPE financing in January 2026. Including those proceeds, cash and cash equivalents are expected to be sufficient to fund the Company’s operating plan into the third quarter of 2026. About the U.S. Biosimilar Pathway Analytical similarity forms the scientific foundation of the 351(k) pathway and represents the most data-intensive phase of biosimilar development. When analytical comparability across critical quality attributes is robustly demonstrated, the FDA may reduce the scope of required clinical studies under its totality-of-the-evidence framework. Sponsors may also seek extrapolation to additional indications of the reference product when scientifically justified. About AEON Biopharma AEON Biopharma is a biopharmaceutical company seeking full-label access to the U.S. therapeutic neurotoxin market via biosimilarity to BOTOX ® . The U.S. therapeutic neurotoxin market exceeds $3.0 billion annually, representing a major opportunity for biosimilar entry. ABP-450 is the same botulinum toxin complex currently approved and marketed for cosmetic indications by Evolus, Inc. under the name Jeuveau ® . ABP-450 is manufactured by Daewoong Pharmaceutical in a facility that has been authorized by the U.S. Food and Drug Administration, Health Canada, and European Medicines Agency for the manufacture of botulinum toxin products. The product is approved as a biosimilar in India, Mexico, and the Philippines. 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. To learn more about AEON, visit . 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 completion of, or outcome of results from, primary comparative analytical studies, or 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 completion of additional analytical testing of ABP-450; (ii) the completion of additional functional analyses of ABP-450; (iii) the expected Type 2b meeting with the FDA and potential path forward to biosimilarity designation; (iv) AEON’s ability to receive full-label access to the U.S. therapeutic neurotoxin market via biosimilarity to BOTOX ® on an accelerated timeline or at all; (v) the outcome of any legal proceedings that may be instituted against AEON or others; (vi) AEON’s future capital requirements; (vii) AEON’s ability to raise financing in the future; (viii) AEON’s ability to continue to meet continued stock exchange listing standards; (ix) the possibility that AEON may be adversely affected by other economic, business, regulatory, and/or competitive factors; (x) the outcomes from any meetings or discussions with regulatory authorities; (xi) the timing of, or results from, any testing performed on AEON’s product; and (xii) 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 . 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: Laurence Watts New Street Investor Relations +1 619 916 7620 laurence@newstreetir.com Source: AEON Biopharma AEON BIOPHARMA, INC. CONSOLIDATED BALANCE SHEETS (in thousands, except share data and par value amounts) December 31, December 31, 2025 2024 ASSETS Current assets: Cash and cash equivalents $ 3,006 $ 13 Prepaid expenses and other current assets 392 1,577 Total current assets 3,398 1,590 Property and equipment, net 162 235 Operating lease right-of-use asset 1,052 1,288 Other assets 948 29 Total assets $ 5,560 $ 3,142 LIABILITIES AND STOCKHOLDERS' DEFICIT Current liabilities: Accounts payable $ 942 $ 5,910 Accrued clinical trials expenses 1,426 3,571 Accrued compensation 2,872 1,068 Other accrued expenses 1,657 3,600 Total current liabilities 6,897 14,149 Convertible notes at fair value, including related party amount of $34,600 and $11,689, at December 31, 2025 and 2024, respectively 34,600 11,689 Operating lease liability 893 1,145 Derivative liability 14,879 — Warrant liabilities 3,276 1,187 Contingent consideration liability 42 3,541 Total liabilities 60,587 31,711 Commitments and contingencies Stockholders’ Deficit: Class A common stock, $0.0001 par value; 1,040,000,000 and 500,000,000 shares authorized at December 31, 2025 and 2024, and 12,105,902 and 555,511 shares issued and outstanding at December 31, 2025 and 2024, respectively 9 4 Additional paid-in capital 415,783 403,024 Accumulated deficit (470,819 ) (431,597 ) Total stockholders' deficit (55,027 ) (28,569 ) Total liabilities and stockholders' deficit $ 5,560 $ 3,142 AEON BIOPHARMA, INC. CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE (LOSS) INCOME (in thousands, except share and per share data) Years Ended December 31, 2025 2024 Operating expenses: Selling, general and administrative $ 12,208 $ 13,643 Research and development 4,094 14,181 Change in fair value of contingent consideration (3,499 ) (100,809 ) Total operating costs and expenses 12,803 (72,985 ) (Loss) income from operations (12,803 ) 72,985 Other (loss) income: Change in fair value of convertible notes (22,911 ) 3,311 Change in fair value of warrants 84,934 (14,719 ) Loss on issuance of warrants (75,644 ) — Loss on embedded forward purchase agreements — (19,667 ) Loss on derivative liability (13,088 ) — Other income, net 290 95 Total other loss, net (26,419 ) (30,980 ) (Loss) income before taxes (39,222 ) 42,005 Income taxes — — Net (loss) income $ (39,222 ) $ 42,005 Basic net (loss) income per share $ (3.95 ) $ 77.74 Diluted net (loss) income per share (3.95 ) 72.93 Weighted average shares of common stock outstanding used to compute basic net (loss) income per share 9,921,587 540,360 Weighted average shares of common stock outstanding used to compute diluted net (loss) income per share 9,921,587 575,945 The accompanying consolidated financial statements have been prepared in accordance with generally accepted accounting principles in the United States of America (“U.S. GAAP”). The consolidated financial statements include the accounts of the Company and its controlled subsidiaries.

受伤的皮肤有朝一日能否完美再生而不留疤痕？哈佛大学干细胞与再生生物学系 Ya-Chieh Hsu 教授团队发表在《Cell》上的一项重磅研究，给出了充满希望的答案。该研究通过深入解析胚胎与出生后皮肤伤口愈合的差异机制，发现皮肤的器官级再生潜力并非出生后永久消失，而是被 “神经过度支配” 这一关键屏障所抑制——只需解除这一抑制，就能重新唤醒皮肤再生所有细胞类型的能力，为人类无疤痕伤口愈合疗法的开发奠定了核心基础。 “本质上，我们通过研究胚胎如何实现完美愈合，找到了让伤口愈合结果大幅提升的方法。” 资深作者、哈佛干细胞研究所核心教员 Ya-Chieh Hsu 教授表示，“大多数皮肤损伤后，除了表皮能修复，毛囊、神经、脂肪等大部分细胞类型都无法再生，最终形成疤痕。但我们的发现表明，这些器官保留着固有的再生潜力，只是被后天机制抑制了，而解除这种抑制，就足以让再生发生。” 皮肤常被认为是具备自我再生能力的器官，但这种再生远非完美。受伤后，表皮干细胞会快速闭合创面，而成纤维细胞会沉积致密的胶原瘢痕组织，取代原本复杂的皮肤结构。早期研究已证实胚胎伤口能无疤痕愈合，但这项历时五年的小鼠研究进一步揭示，胚胎皮肤的愈合不仅无疤，还能完全再生所有细胞类型，包括毛囊、立毛肌、淋巴管、黑素细胞、感觉神经、交感神经和真皮脂肪细胞，且这些再生细胞能形成功能互联的 “三谱系单元”，在寒冷刺激下正常产生鸡皮疙瘩（立毛反应），与未受伤皮肤在形态和功能上几乎无差异。然而，这种强大的再生能力在出生后迅速消失，最显著的转变发生在胚胎第 16.5 天（E16.5）到出生后第 5 天（P5）之间，一个仅 8 天的关键窗口内。 为揭开这一转变的奥秘，主要作者 Hannah Tam 博士在解剖显微镜下对小鼠胚胎和新生小鼠进行显微手术，用活检穿孔工具制造全层皮肤损伤，并通过荧光珠和指甲花墨水标记伤口位置（避免因愈合过好而无法识别）。研究团队通过单细胞 RNA 测序（scRNA-seq）分析发现，出生后伤口中出现了一种胚胎伤口中不存在的 “出生后伤口特异性成纤维细胞（PWF）”，这类细胞富集表达 Timp1、Cxcl12 和 Ccl7 三种分泌因子。体内筛选实验证实，这三种因子单独过表达时，均能阻断胚胎皮肤的多谱系再生，且都会诱导一个共同表型—— 神经过度支配（伤口区域神经纤维密度和分支显著增加），而这正是出生后伤口的典型特征。 有趣的是，研究团队最初假设免疫细胞是再生差异的关键，但实验却推翻了这一猜想。他们向胚胎羊水中注射脂多糖（LPS），或在胚胎伤口中过表达 Cxcl5、Csf2 等促炎因子，虽显著增加了髓系细胞浸润，却并未影响胚胎皮肤的再生能力。而仅通过过表达神经生长因子（Ngf）诱导神经过度支配，就足以完全阻断胚胎伤口的多谱系再生。这表明，神经过度支配才是抑制再生的核心屏障，而非免疫细胞浸润。 进一步机制研究发现，PWF 分泌的 Cxcl12 是驱动神经过度支配的关键分子。Cxcl12 通过结合感觉神经元表面的受体 Cxcr4，将大量神经纤维招募到伤口床；而出生后感觉神经元中 Cxcr4 的表达量显著高于胚胎期，使得这种招募效应更加强烈。当研究人员利用 Pdgfra-Cre 小鼠特异性敲除成纤维细胞中的 Cxcl12，或利用 VGlut2-Cre 小鼠敲除感觉神经元中的 Cxcr4 时，出生后伤口的神经过度支配被显著抑制，皮肤成功再生了毛囊、立毛肌、淋巴管等多种细胞类型，且再生组织能形成正确的跨谱系连接。 更令人振奋的是，这种再生能力还可通过临床常用手段激活。研究团队向出生后小鼠伤口局部注射肉毒杆菌毒素 A（BoNT/A，即 Botox），通过切割 SNAP-25 蛋白阻断神经突触小泡释放，不仅减少了神经过度支配，还成功恢复了多谱系再生。此外，向伤口递送靶向感觉神经元的 AAV 载体，通过 Cre 激活的 caspase-3 选择性消融感觉神经，也取得了类似效果。这些结果表明，无论是抑制 Cxcl12-Cxcr4 通路阻断神经招募，还是直接阻断神经信号传递，都能解除再生抑制。 值得注意的是，这种再生策略对成年小鼠同样有效。成年 Cxcl12 条件敲除小鼠的伤口，或经 BoNT/A 处理的成年伤口，虽再生程度不及胚胎期，但仍能显著恢复多种细胞类型，远超野生型成年小鼠仅能上皮化的愈合效果。若同时靶向 Cxcl12、Timp1 和 Ccl7 三种因子，再生效果会进一步提升。这意味着，即使是成年皮肤，其潜在的再生能力也能被重新唤醒。 “我们原本以为需要重建一系列促进再生的因子来模拟胚胎愈合，结果证明解决方案要简单得多——只需解除一个‘刹车’。”Hsu 教授说。这项研究不仅颠覆了 “免疫细胞主导再生调控” 的传统认知，更首次明确了成纤维细胞-神经相互作用在伤口愈合中的核心抑制作用，为无疤痕伤口治疗提供了全新靶点。未来，通过局部抑制 Cxcl12 信号或短暂阻断伤口神经活动，或许能让人类伤口实现胚胎级的完美再生，为慢性伤口、严重烧伤等患者带来新的治疗希望。 参考文献： Hannah T. Tam et al, Hyperinnervation Inhibits Organ-Level Regeneration in Mammalian Skin, Cell (2026). DOI: 10.1016/j.cell.2026.02.027. 本文仅用于学术分享，转载请注明出处。若有侵权，请联系微信：bioonSir 删除或修改！ 点击下方「阅读原文」，前往生物谷官网查询更多生物相关资讯~