Annovis Bio Reports Third Quarter Financial Results and Provides Business Update
Annovis Bio (NYSE: ANVS) reported Q3 2024 financial results and clinical updates. The FDA granted clearance for pivotal Phase 3 studies of buntanetap in early Alzheimer's disease, with a 6-month symptomatic study starting Q1 2025. The company reported $13.6 million in cash and equivalents, with Q3 operating expenses of $4.4 million. Net loss was $0.97 per share, compared to $1.63 in Q3 2023. The company raised $4.4 million from ELOC facility and $7.1 million from warrant exercises. Three new patents were filed for combination therapies involving buntanetap.
Annovis Bio (NYSE: ANVS) ha riportato i risultati finanziari del terzo trimestre 2024 e aggiornamenti clinici. La FDA ha concesso l'approvazione per studi pivotali di fase 3 su buntanetap nella malattia di Alzheimer precoce, con uno studio sintomatico di 6 mesi che inizierà nel primo trimestre del 2025. L'azienda ha riportato 13,6 milioni di dollari in contante e equivalenti, con spese operative del terzo trimestre di 4,4 milioni di dollari. La perdita netta è stata di 0,97 dollari per azione, rispetto a 1,63 dollari nel terzo trimestre del 2023. L'azienda ha raccolto 4,4 milioni di dollari tramite il sistema ELOC e 7,1 milioni di dollari da esercizi di warrant. Sono stati depositati tre nuovi brevetti per terapie combinatorie che coinvolgono buntanetap.
Annovis Bio (NYSE: ANVS) reportó los resultados financieros del tercer trimestre de 2024 y actualizaciones clínicas. La FDA otorgó la autorización para estudios pivotales de fase 3 de buntanetap en la enfermedad de Alzheimer temprana, con un estudio sintomático de 6 meses que comenzará en el primer trimestre de 2025. La empresa reportó 13,6 millones de dólares en efectivo y equivalentes, con gastos operativos en el tercer trimestre de 4,4 millones de dólares. La pérdida neta fue de 0,97 dólares por acción, en comparación con 1,63 dólares en el tercer trimestre de 2023. La empresa recaudó 4,4 millones de dólares a través de la instalación ELOC y 7,1 millones de dólares por el ejercicio de warrants. Se presentaron tres nuevas patentes para terapias combinadas que involucran buntanetap.
Annovis Bio (NYSE: ANVS)는 2024년 3분기 재무 결과와 임상 업데이트를 발표했습니다. FDA는 초기 알츠하이머병에서 buntanetap의 중요한 3상 연구에 대한 승인을 부여했으며, 6개월간의 증상 연구가 2025년 1분기에 시작될 예정입니다. 회사는 1,360만 달러의 현금과 현금성 자산을 보고했으며, 3분기 운영 비용은 440만 달러였습니다. 순손실은 주당 0.97달러였으며, 2023년 3분기의 1.63달러와 비교됩니다. 회사는 ELOC 시설을 통해 440만 달러를 조달하고, 워런트 행사로 710만 달러를 모금했습니다. buntanetap을 포함하는 조합 치료법에 대해 3개의 새로운 특허가 출원되었습니다.
Annovis Bio (NYSE: ANVS) a annoncé les résultats financiers du troisième trimestre 2024 et des mises à jour cliniques. La FDA a accordé l'approbation pour des études pivotales de phase 3 sur buntanetap dans la maladie d'Alzheimer précoce, avec une étude symptomatique de 6 mois commençant au premier trimestre 2025. La société a déclaré 13,6 millions de dollars en liquidités et équivalents, avec des dépenses opérationnelles de 4,4 millions de dollars pour le troisième trimestre. La perte nette était de 0,97 dollar par action, contre 1,63 dollar au troisième trimestre 2023. L'entreprise a levé 4,4 millions de dollars grâce à l'installation ELOC et 7,1 millions de dollars par l'exercice de warrants. Trois nouveaux brevets ont été déposés pour des thérapies combinées impliquant buntanetap.
Annovis Bio (NYSE: ANVS) hat die finanziellen Ergebnisse für das dritte Quartal 2024 und klinische Updates veröffentlicht. Die FDA hat die Genehmigung für die entscheidenden Phase-3-Studien zu buntanetap bei leichter Alzheimer-Krankheit erteilt, wobei eine 6-monatige symptomatische Studie im ersten Quartal 2025 beginnt. Das Unternehmen berichtete von 13,6 Millionen Dollar in Bargeld und Äquivalenten, bei Betriebskosten von 4,4 Millionen Dollar im dritten Quartal. Der Nettoverlust belief sich auf 0,97 Dollar pro Aktie, verglichen mit 1,63 Dollar im dritten Quartal 2023. Das Unternehmen hat 4,4 Millionen Dollar über die ELOC-Einrichtung aufgenommen und 7,1 Millionen Dollar durch die Ausübung von Warrants. Drei neue Patente wurden für Kombinationstherapien beantragt, die buntanetap umfassen.
- FDA clearance received for Phase 3 studies in Alzheimer's disease
- Operating expenses decreased significantly from $14.9M to $4.4M YoY
- Net loss per share improved from $1.63 to $0.97 YoY
- Successfully raised $11.5M through ELOC facility and warrant exercises
- Filed three new patents strengthening IP portfolio
- Continued operating losses with $4.4M expenses in Q3
- Relatively cash position of $13.6M considering upcoming Phase 3 trials
- Ongoing dilution through ELOC facility utilization
Insights
The Q3 results reveal significant financial developments for Annovis Bio. With
The FDA's clearance for Phase 3 trials represents a important milestone for buntanetap's development in early Alzheimer's disease. The dual-track approach with a 6-month symptomatic study and 18-month disease-modifying study is strategically sound. The FDA's validation of safety data, including liver enzymes and drug interactions, significantly de-risks the development pathway. The new patent filings for combination therapies with Trulicity and Viagra demonstrate innovative thinking in treatment approaches. However, investors should note that Phase 3 success is not guaranteed and the timeline to potential commercialization remains lengthy, with the first study starting in Q1 2025.
MALVERN, Pa., Nov. 11, 2024 (GLOBE NEWSWIRE) -- via IBN – Annovis Bio, Inc. (NYSE: ANVS) ("Annovis" or the "Company"), a clinical-stage drug platform company developing novel therapies for neurodegenerative diseases, such as Alzheimer's disease (AD) and Parkinson's disease (PD), today announced financial results for the third quarter ended September 30, 2024, and provided a business update.
"The third quarter was marked by important milestones outlining the next steps for buntanetap," said Maria Maccecchini, Ph.D., Founder, President, and CEO of Annovis. "The FDA gave us the green light to initiate confirmatory Phase 3 studies for early AD, and our team has been working hard to begin them in the coming year. We also strengthened our intellectual property portfolio by filing unique patents protecting new combinations of buntanetap with other medications for improving cognition."
Clinical Updates
- On October 10, 2024, Annovis conducted a successful End-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA), to discuss the data from its Phase 2/3 AD study and the next steps for buntanetap.
- During the meeting, the FDA granted clearance to proceed with pivotal Phase 3 studies: a 6-month study aimed at confirming buntanetap’s symptomatic effects and an 18-month study designed to demonstrate potential disease-modifying effects.
- The FDA raised no concerns about the Company’s data on buntanetap’s safety, including liver enzymes, drug interactions, dose selection, pharmacokinetics, population pharmacokinetics, and confirmed that development can proceed using the new crystal form of buntanetap.
- The 6-month symptomatic study is expected to begin in Q1 2025.
Cash Runway and Third Quarter 2024 Financial Results
- As of November 8, 2024, Annovis had cash and cash equivalents of
$13.6 million . The company has an adequate runway for all Phase 3 preparatory studies and for entering the pivotal Phase 3 AD study in Q1 2025. - During the third quarter, Annovis received
$4.4 million in net cash from its April 2024 ELOC facility. As of November 8, 2024, a total of$12.7 million in net cash has been raised with the ELOC year to date. Recent ELOC proceeds will ensure that Annovis has sufficient liquidity to enter the Phase 3 AD study. - Annovis received
$7.1 million in net cash from the exercises of Canaccord Warrants during the third quarter, in July. - Total operating expenses for the three months ending September 30, 2024, were
$4.4 million , which included research and development expenses of$2.7 million and general and administrative expenses of$1.7 million . This compares to total operating expenses for the three months ending September 30, 2023, of$14.9 million , which included research and development expenses of$13.9 million and general and administrative expenses of$1.0 million . - Annovis reported a
$0.97 b asic and diluted net loss per common share for the three months ending September 30, 2024. This compares to a$1.63 b asic and diluted net loss per common share for the three months ending September 30, 2023.
Conferences
- The Company presented two scientific posters at the 17th Clinical Trials on Alzheimer’s Disease (CTAD) conference, held October 29-November 1 in Madrid, Spain. The posters were focused on buntanetap’s efficacy data in early AD patients from Phase 2/3 study and the biomarker data.
Patents
- On September 30, 2024, Annovis announced the filing of three new patents for innovative combination therapies involving its lead compound, buntanetap. These patents cover combinations of buntanetap with Trulicity (dulaglutide), Viagra (sildenafil), or a combination of all three, creating a multifaceted approach to treating neurodegenerative diseases.
Team Expansion
- The Company announced the addition of Matthew Peterson, Ph.D., as Senior Clinical Scientist. Dr. Peterson will be responsible for quality and rigor in the upcoming clinical trials for AD and PD, ensuring their successful completion.
About Annovis Bio, Inc. Headquartered in Malvern, Pennsylvania, Annovis Bio is dedicated to addressing neurodegeneration in diseases such as AD and PD. The Company’s innovative approach targets multiple neurotoxic proteins, aiming to restore brain function and improve the quality of life for patients. For more information, visit www.annovisbio.com and follow us on LinkedIn, YouTube, and X.
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Forward-Looking Statements This press release contains "forward-looking" statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These statements include, but are not limited to, the Company's plans related to clinical trials. Forward-looking statements are based on current expectations and assumptions and are subject to risks and uncertainties that could cause actual results to differ materially from those projected. Such risks and uncertainties include, but are not limited to, those related to patient enrollment, the effectiveness of Buntanetap, and the timing, effectiveness, and anticipated results of the Company's clinical trials evaluating the efficacy, safety, and tolerability of Buntanetap. Additional risk factors are detailed in the Company's periodic filings with the SEC, including those listed in the "Risk Factors" section of the Company's Annual Report on Form 10-K and Quarterly Reports on Form 10-Q. All forward-looking statements in this press release are based on information available to the Company as of the date of this release. The Company expressly disclaims any obligation to update or revise its forward-looking statements, whether as a result of new information, future events, or otherwise, except as required by law.
Contacts
Annovis Bio, Inc.
101 Lindenwood Drive
Suite 225
Malvern, PA 19355
www.annovisbio.com
Investor Contact
Scott McGowan
InvestorBrandNetwork (IBN)
Phone: 310.299.1717
IR@annovisbio.com
Investor Website
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