Annovis Bio Inc

Annovis Bio, Inc. (NYSE: ANVS) is a clinical-stage drug platform company addressing neurodegeneration such as Alzheimer’s disease (AD), Parkinson’s disease (PD) and other chronic neurodegenerative diseases. The Company is developing its lead product candidate, Buntanetap, which is designed to address AD, PD, and potentially other chronic neurodegenerative diseases. Buntanetap is a synthetically produced small molecule, orally administered, brain penetrant compound. Its product candidate ANVS405 is an intravenous drug being developed for acute indications and focused on protecting the brain after traumatic brain injury (TBI) and/or stroke.

Recent Financial and Business Updates:

• Clinical Updates
  • Announced Last Patient Last Visit in Phase III Study of Buntanetap in Parkinson’s Disease (PD): ANVS reported the successful completion of the last patient last visit for its Phase III study of buntanetap in Parkinson’s Disease (PD) on December 5, 2023. With a notable level of participation and record-paced enrollment, out of 616 patients screened, 523 were enrolled across 67 sites, surpassing expectations with screen failure and drop-out rates below projections.
  • Full Enrollment for Phase II/III Alzheimer’s Disease (AD) Trial Exceeding Projections: On November 27, 2023, ANVS declared full enrollment for its Phase II/III study of buntanetap in Alzheimer’s Disease (AD), surpassing original projections. The randomized, double-blind, placebo-controlled trial, involving 353 patients across 54 U.S. sites, demonstrated an enrollment of over 700 patients, emphasizing the study’s significant progress. ANVS also provided updates on the timeline for top-line efficacy data, now anticipated in April.
  • Novel Biomarker Measurements in Plasma of Parkinson’s Patients: On November 2, 2023, ANVS presented novel data on biomarkers in plasma of PD patients, showing a significant decrease in TAR DNA-binding protein 43 (TDP43) levels, a first-of-its-kind achievement in human trials. The data supports buntanetap's unique mechanism of action and marks a notable advancement in disease monitoring, benefiting both patients and medical practitioners.
• Appointment of Andrew Walsh as Vice President Finance: ANVS appointed Andrew Walsh as VP Finance on December 1, 2023, leveraging his 12 years of finance operations experience to drive the company’s financial strategies forward. Walsh, joining from Ocugen, brings valuable expertise to ANVS’s finance team, having previously served in senior roles at prominent biotechnology companies. 

• Financial Results
  • Fourth Quarter of 2023: ANVS reported a net loss of USD 22.2 million for the fourth quarter of 2023, compared to USD 7.7 million for the same period in 2022. Research and development expenses increased to USD 8.9 million, primarily due to higher clinical and CMC expenses, offset by a decrease in stock-based compensation expense. General and administrative expenses slightly decreased, while other income (expense) was primarily impacted by a change in fair value of warrants classified as liabilities.
  • Full Year of 2023: For the full year 2023, ANVS reported a net loss of USD 56.2 million, compared to USD 25.3 million in 2022. Research and development expenses rose significantly due to increased clinical and CMC expenses, partially offset by lower stock-based compensation expense. General and administrative expenses decreased, primarily driven by lower stock-based compensation expense, albeit offset by increased professional fees related to identified material weakness and remediation efforts. Other income (expense) was mainly influenced by a change in fair value of warrants classified as liabilities, alongside increased interest income. 

Technical Observation (on the daily chart)

The Relative Strength Index (RSI) over a 14-day period stands at 40.45, currently downward trending towards oversold zone, with expectations of some consolidation or a small upward recovery. Moreover, the price is currently positioned below both the 21-day SMA and 50-day SMA trend-following indicators, which may act as dynamic short-term resistance levels.

Individuals can evaluate the stock based on the support and resistance levels provided in the report in case of keen interest taking into consideration the risk-reward scenario.

Markets are trading in a highly volatile zone currently due to certain macro-economic issues and prevailing geopolitical tensions. Therefore, it is prudent to follow a cautious approach while investing. 

Note 1: Past performance is not a reliable indicator of future performance.

Note 2: The reference date for all price data, currency, technical indicators, support, and resistance level is April 29, 2024. The reference data in this report has been partly sourced from REFINITIV.

Note 3: Investment decisions should be made depending on an individual's appetite for upside potential, risks, holding duration, and any previous holdings. An 'Exit' from the stock can be considered if the Target Price mentioned as per the Valuation and or the technical levels provided has been achieved and is subject to the factors discussed above.

Note 4: Target Price refers to a price level that the stock is expected to reach as per the relative valuation method and or technical analysis taking into consideration both short-term and long-term scenarios.

Note 5: ‘Kalkine reports are prepared based on the stock prices captured either from the New York Stock Exchange (NYSE), NASDAQ Capital Markets (NASDAQ), and or REFINITIV. Typically, all sources (NYSE, NASDAQ, or REFINITIV) may reflect stock prices with a delay which could be a lag of 15-20 minutes. There can be no assurance that future results or events will be consistent with the information provided in the report. The information is subject to change without any prior notice.