AEON Biopharma Reports Third Quarter 2024 Financial Results and Provides Corporate Update
AEON Biopharma reported Q3 2024 financial results and provided a corporate update. The company held a biosimilar advisory meeting with FDA regarding ABP-450 (prabotulinumtoxinA) as a biosimilar to BOTOX®. AEON plans to initiate comparative analytical studies in Q4 2024, subject to available resources. The 351(k) regulatory pathway could enable ABP-450 to reach the U.S. market under a single approval for all BOTOX's current and future therapeutic indications. The company's main limitation is current capital resources, and they are evaluating options to execute their regulatory strategy. A Biosimilar Biological Product Development Type 2 meeting with FDA is planned for 2025.
AEON Biopharma ha riportato i risultati finanziari del terzo trimestre 2024 e fornito un aggiornamento aziendale. L'azienda ha tenuto un incontro consultivo sui biosimilari con la FDA riguardo a ABP-450 (prabotulinumtoxinA) come biosimilare di BOTOX®. AEON prevede di avviare studi comparativi analitici nel quarto trimestre del 2024, a seconda delle risorse disponibili. Il percorso normativo 351(k) potrebbe consentire ad ABP-450 di arrivare sul mercato statunitense con un'unica approvazione per tutte le attuali e future indicazioni terapeutiche di BOTOX. La principale limitazione dell'azienda sono le risorse di capitale attuali e stanno valutando opzioni per attuare la loro strategia regolatoria. È previsto un incontro di tipo 2 per lo sviluppo di prodotti biologici biosimilari con la FDA nel 2025.
AEON Biopharma informó sobre los resultados financieros del tercer trimestre de 2024 y proporcionó una actualización corporativa. La compañía celebró una reunión asesoría sobre biosimilares con la FDA respecto a ABP-450 (prabotulinumtoxinA) como biosimilar de BOTOX®. AEON planea iniciar estudios analíticos comparativos en el cuarto trimestre de 2024, sujetos a los recursos disponibles. La vía regulatoria 351(k) podría permitir que ABP-450 llegue al mercado estadounidense bajo una única aprobación para todas las indicaciones terapéuticas actuales y futuras de BOTOX. La principal limitación de la empresa son los recursos de capital actuales, y están evaluando opciones para ejecutar su estrategia regulatoria. Se planea una reunión Tipo 2 para el desarrollo de productos biológicos biosimilares con la FDA para 2025.
AEON Biopharma는 2024년 3분기 재무 결과를 보고하고 기업 업데이트를 제공했습니다. 이 회사는 ABP-450 (prabotulinumtoxinA)에 관한 바이오시밀러 자문 회의를 FDA와 개최했으며, 이는 BOTOX®의 바이오시밀러로 자리잡고 있습니다. AEON은 2024년 4분기에 비교 분석 연구를 시작할 계획이며, 이는 이용 가능한 자원에 따라 달라질 수 있습니다. 351(k) 규제 경로는 ABP-450이 현재 및 미래의 BOTOX 치료 적응증에 대해 단일 승인 하에 미국 시장에 도달할 수 있도록 할 수 있습니다. 회사의 주요 제한 사항은 현재 자본 자원이며, 규제 전략을 실행하기 위한 옵션을 평가하고 있습니다. 2025년에는 FDA와 함께 바이오시밀러 생물학적 제품 개발 회의가 예정되어 있습니다.
AEON Biopharma a présenté les résultats financiers du troisième trimestre 2024 et fourni une mise à jour de l’entreprise. La société a tenu une réunion consultative sur les biosimilaires avec la FDA concernant ABP-450 (prabotulinumtoxinA) en tant que biosimilaire à BOTOX®. AEON prévoit de lancer des études analytiques comparatives au quatrième trimestre 2024, sous réserve des ressources disponibles. La voie réglementaire 351(k) pourrait permettre à ABP-450 d'atteindre le marché américain sous une approbation unique pour toutes les indications thérapeutiques actuelles et futures de BOTOX. La principale limitation de l'entreprise réside dans les ressources en capital actuelles, et elle évalue des options pour exécuter sa stratégie réglementaire. Une réunion de type 2 pour le développement de produits biologiques biosimilaires avec la FDA est prévue pour 2025.
AEON Biopharma hat die finanziellen Ergebnisse für das dritte Quartal 2024 veröffentlicht und ein Unternehmensupdate gegeben. Das Unternehmen hat ein Beratungstreffen zu Biosimilars mit der FDA bezüglich ABP-450 (prabotulinumtoxinA) als Biosimilar zu BOTOX® abgehalten. AEON plant, im vierten Quartal 2024 vergleichende analytische Studien zu initiieren, abhängig von den verfügbaren Ressourcen. Der regulatorische Weg 351(k) könnte es ABP-450 ermöglichen, den US-Markt mit einer einzigen Genehmigung für alle aktuellen und zukünftigen therapeutischen Indikationen von BOTOX zu erreichen. Die Hauptbeschränkung des Unternehmens sind die aktuellen Kapitalressourcen, und sie prüfen Optionen zur Umsetzung ihrer Regulierungstrategie. Ein Typ-2-Meeting zur Entwicklung biologischer Produkte mit der FDA ist für 2025 geplant.
- FDA alignment on 351(k) regulatory pathway requirements for ABP-450
- Potential for single approval covering all BOTOX therapeutic indications
- Planned initiation of comparative analytical studies in Q4 2024
- capital resources constraining company operations
- Execution of development plans dependent on securing additional funding
Insights
The FDA meeting outcome for AEON's biosimilar development strategy is significant but comes with substantial execution risks. The 351(k) pathway could potentially allow ABP-450 to target BOTOX's full therapeutic portfolio under a single approval, representing a
- The company's explicit mention of capital resource limitations raises red flags about their ability to execute the planned analytical studies
- The timeline for the comparative analytical studies in Q4 2024 is contingent on securing funding
- While the regulatory pathway is clearer, the development program still faces significant hurdles before potential commercialization
The biosimilar strategy could substantially reduce development costs compared to individual indication approvals, but the company's financial constraints pose a material risk to program execution. The upcoming analytical studies will be important in determining the program's viability.
The company's financial situation presents significant concerns. Key observations:
- The explicit mention of capital resources as their "single biggest limitation" suggests imminent funding needs
- With a relatively small market cap of
$29.5M , raising substantial capital could lead to significant dilution - The dependency of critical development milestones on securing funding creates uncertainty in the timeline
While the 351(k) pathway represents a potentially cost-effective route to market, the company's current financial position may force them to explore strategic alternatives or partnerships. Investors should closely monitor the company's ability to secure funding for the planned analytical studies.
– 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 | — | |||||||
| 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, | 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 21 | |||||||||||||||||||||
| Operating 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.
FAQ
What regulatory pathway is AEON pursuing for ABP-450 (AEON)?
When will AEON Biopharma start comparative analytical studies for ABP-450?
What is the main challenge facing AEON Biopharma in Q3 2024?
When is AEON's next FDA meeting scheduled for ABP-450?
