MALVERN, PA — In a recent financial report for 2023, Annovis Bio, Inc. (NYSE: ANVS) proclaimed progress in the battle against neurodegenerative diseases; however, the path to potential breakthroughs has proven more expensive than anticipated, affecting year-end results.
Clinical trials in both Parkinson’s Disease (PD) and Alzheimer’s Disease (AD) saw excellent levels of enrollment and participation, with the last patient completing their PD trial visit in December. Over six hundred total PD patients were screened, with 471 completing the trial across a record 67 sites, including 43 in the U.S. and 24 in the European Union.
Meanwhile, Annovis’ AD Phase II/III study of the drug Buntanetap exceeded initial expectations, with a fully enrolled roster of 353 patients—33 above the original target. The double-blind, placebo-controlled trial consists of patients receiving either one of three doses of Buntanetap or a placebo, in addition to their standard care, for 12 weeks. Results for this study are expected in April.
In a groundbreaking discovery, Annovis reported biomarker measurements in plasma of PD patients that indicated a promising reduction in levels of TAR DNA-binding protein 43, a neurotoxic protein linked to impaired axonal transport, inflammation, and nerve cell death. This finding marks the first time a drug has been reported to reduce these levels in humans, suggesting Buntanetap’s unique inhibitory effect on multiple neurotoxic aggregating proteins.
Outside of clinical areas, Annovis displayed strategic staffing decisions, appointing Andrew Walsh as Vice President of Finance. His 12-year career in finance operations will contribute to the firm’s growth as it continues efforts in biotechnological innovation.
However, these advancements came at a considerable financial cost. Though the company’s cash and cash equivalents stood at $5.8 million as of December 31, 2023, the figure is a marked decrease from $28.4 million the previous year. This reduction was largely attributed to operation funding demands, despite some offset by an ATM in March and an Equity Offering in November.
Substantial costs associated with the PD and AD studies have primarily driven the increase in research and development expenses to $38.8 million for 2023, up from $16.5 million the previous year. This surge in costs was partially offset by a decrease of $1.2 million in stock-based compensation expense and a decrease of $0.5 million for lower employee allocations to R&D.
General and administrative expenses also decreased, primarily due to a $3.4 million reduction in stock-based compensation expense. Despite this savings, the decrease was somewhat offset by an increase of $0.9 million in professional fees incurred in relation to identified material weaknesses and associated remediation efforts.
Other income (expense) was recorded at ($11.2) million, compared to $0.2 million for the same period in 2022. This decrease was primarily linked to recording an $11.8 million expense related to the changing fair value of warrants classified as liabilities, yet was somewhat alleviated by increased interest income owing to higher average interest rates during 2023.
Annovis Bio’s pursuit of breakthrough therapeutics in the fight against neurodegenerative diseases is a journey of both triumph and trials. While Q4 and full-year 2023 financial results reflect the significant cost of this endeavor, the clinical progress and promising discoveries highlight the potential for a transformative impact on patient care in the years to come. With unwavering team execution and a clear strategic mission, Annovis looks ahead to what promises to be an exhilarating journey.
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