Annovis Bio Reports Second Quarter Financial Results and Provides Business Update

Rhea-AI Summary

Annovis Bio (NYSE: ANVS) reported Q2 2024 financial results and provided a business update. Key highlights include:

1. Completed pivotal Phase 2/3 Alzheimer's and Phase 3 Parkinson's studies with encouraging data for buntanetap.

2. Introduced a new crystalline form of buntanetap with improved properties.

3. Q2 2024 financial results: $4.0 million in cash and cash equivalents as of June 30, 2024; $7.8 million in total operating expenses; $0.44 basic and diluted net loss per share.

4. Received $7.1 million from warrant exercises and $7.0 million from ELOC facility, bringing cash position to $12.1 million as of August 14, 2024.

5. Filed new patents for buntanetap's crystalline form and manufacturing process.

6. Expanded team with key appointments in business development, communications, statistics, and quality.

Positive

• Completed Phase 2/3 Alzheimer's study showing 3.3-point improvement on ADAS-Cog11 test after three months of buntanetap treatment
• Phase 3 Parkinson's study revealed significant improvements in MDS-UPDRS and cognition across several PD subpopulations
• Introduced new crystalline form of buntanetap with improved solubility, stability, and 20 years additional patent life
• Received $14.1 million from warrant exercises and ELOC facility, improving cash position to $12.1 million
• Filed new composition of matter patent for buntanetap's crystalline form and manufacturing process
• Expanded team with key appointments to strengthen business development and operations

Negative

• Q2 2024 net loss of $0.44 per share
• Total operating expenses increased to $7.8 million in Q2 2024 compared to $7.3 million in Q2 2023
• Cash and cash equivalents decreased to $4.0 million as of June 30, 2024, from $5.7 million as of December 31, 2023

Insights

Financial Analyst

Annovis Bio's Q2 2024 results reveal a mixed financial picture. The company's cash position improved to $12.1 million as of August 14, up from $4.0 million on June 30, thanks to warrant exercises and ELOC facility. This bolsters short-term liquidity but may lead to dilution. Operating expenses decreased to $7.8 million from $9.8 million year-over-year, primarily due to lower R&D costs. The narrowed net loss of $0.44 per share, compared to $1.07 last year, is encouraging. However, the company's burn rate remains high relative to its cash position, which could necessitate additional funding for upcoming pivotal studies.

Medical Research Analyst

Annovis Bio's clinical trial updates for buntanetap are promising. In Alzheimer's, the 3.3% improvement in ADAS-Cog11 scores is clinically significant, especially given the enhanced efficacy in APOE4 carriers. The absence of ARIA is a crucial safety advantage over some competitors. For Parkinson's, improvements in MDS-UPDRS and cognition across subpopulations are encouraging, particularly in longer-diagnosed patients and those with PIGD. The cognitive benefits in both AD and PD suggest a potential dual-indication drug, which could significantly expand the market opportunity. The new crystalline form's improved properties and extended patent life further strengthen the drug's commercial potential.

Market Research Analyst

Annovis Bio's recent developments position it competitively in the neurodegenerative disease market. The positive clinical data for both Alzheimer's and Parkinson's diseases expands the potential patient population. The new crystalline form of buntanetap, with its 20-year patent extension, significantly enhances the drug's market exclusivity. The preclinical data showing synergy with GLP-1 agonists opens possibilities for combination therapies, potentially addressing a broader spectrum of symptoms. However, the company faces fierce competition in the AD space from recently approved drugs. The expanding leadership team suggests preparation for commercialization, but Annovis will need to secure substantial funding for pivotal trials and potential launch, which may impact future stock performance.

MALVERN, Pa., Aug. 15, 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 second quarter ended June 30, 2024, and provided a business update. 

"The recent months have been productive for our company," said Maria Maccecchini, Ph.D., Founder, President, and CEO of Annovis Bio. "We've completed pivotal Phase 2/3 Alzheimer's and Phase 3 Parkinson's studies, both of which revealed very encouraging data for buntanetap. Additionally, we’ve introduced a new crystalline form of buntanetap with improved properties, further strengthening our IP portfolio. These milestones position us strongly as we move closer to providing much-needed treatments to patients."

Clinical Trial Updates 

Alzheimer’s Disease (AD) 

• On April 29, 2024, Annovis Bio reported data from its completed Phase 2/3 AD study. The results showed that buntanetap significantly improved cognition in patients with early AD, with a 3.3-point improvement on the ADAS-Cog11 test after three months of treatment, compared to a 0.3-point improvement in the placebo group.
• The study also indicated a trend toward reduced plasma tau protein levels, consistent with previous findings, suggesting a potential disease-modifying effect of buntanetap.
• A follow-up analysis, on June 11, 2024, demonstrated that buntanetap was particularly effective in improving cognition among high-risk APOE4 carriers, showing a 3.15-point improvement.
  
• Bunetanetap was found to be equally safe in both APOE4 carriers and non-carriers, with no instances of Amyloid-Related Imaging Abnormalities (ARIA) observed. 

Parkinson’s Disease (PD) 

• On July 2, 2024, Annovis Bio announced the Phase 3 PD study data, which revealed that buntanetap led to significant improvements in both the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) and cognition across several PD subpopulations. 
• Buntanetap showed a particularly strong response in individuals diagnosed with PD for more than three years as well as in those with postural instability and gait disorder (PIGD). 
• Moreover, buntanetap halted cognitive decline in all enrolled patients and improved cognition in those with mild dementia, mirroring the positive results observed in our AD studies. 

Second Quarter 2024 Financial Results

• Annovis Bio received $7.1 million net cash from exercises of Canaccord warrants in July 2024.  
• Cumulatively to date, Annovis Bio received $7.0 million net cash from ELOC facility announced in April 2024.
• The Company’s cash and cash equivalents totaled $4.0 million as of June 30, 2024, compared to $5.7 million as of December 31, 2023. The Company had 11.7 million shares of common stock outstanding as of June 30, 2024. 
• After recent warrant exercises and ELOC share placements, as of August 14, 2024, Annovis Bio had cash and cash equivalents of $12.1 million, which we believe is sufficient to support operations through the planned AD and PD FDA meetings in Fall and continuing until the initiation of the two pivotal studies planned. 
• Total operating expenses for the three months ended June 30, 2024, were $7.8 million, which included research and development expenses of $5.8 million and general and administrative expenses of $2.0 million. This compares to total operating expenses for the three months ended June 30, 2023, of $9.8 million, which included research and development expenses of $8.2 million and general and administrative expenses of $1.5 million.  
• Annovis Bio reported a $0.44 basic and diluted net loss per common share for the three months ended June 30, 2024. This compares to a $1.07 basic and diluted net loss per common share for the three months ended June 30, 2023. 

Patents 

• The Company filed a new composition of matter patent covering a novel crystal form of buntanetap and its use for treating and/or preventing various neurodegenerative conditions. The new crystalline form offers significant advantages over the less structured, old semi-crystalline form, including better solubility and stability as well as an additional 20 years of patent life.
• The Company has filed a provisional patent for the methods of manufacturing this new crystalline form, covering the entire synthesis process—from basic starting materials to finished GMP product—suitable for large-scale manufacturing at ton quantities.
• On July 16, 2024, Annovis Bio received FDA approval to continue the Phase 3 development with the new crystal form. 
• Additionally, the Company was granted a U.S. patent for the use of buntanetap in the treatment of acute traumatic brain injury.

Team Updates 

• On July 9, 2024, Annovis Bio announced the expansion of its team with several key appointments: Mark White as Chief Business Officer, Alexander Morin as Director of Strategic Communications, Hilda Maibach as Senior Vice President of Statistics, and Blake Jensen as Head of Quality. 

Other Achievements 

• On May 21, 2024, the Company shared a new scientific article focused on the similarities and differences in buntanetap’s pharmacokinetic behavior between several animal models and humans, summarizing years of research. 
• On August 6, 2024, Annovis Bio revealed new preclinical data showing a synergistic improvement on cognition when combining buntanetap with the GLP-1 agonist Trulicity®. 

About Annovis Bio, Inc.
Headquartered in Malvern, Pennsylvania, Annovis Bio Inc. 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. 

Investor Alerts
Interested investors and shareholders are encouraged to sign up for press releases and industry updates by registering for Email Alerts at https://www.Annovisbio.com/email-alerts. 

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 

FAQ

What were the key results from Annovis Bio's Phase 2/3 Alzheimer's study for buntanetap?

Annovis Bio's Phase 2/3 Alzheimer's study showed that buntanetap significantly improved cognition in early AD patients, with a 3.3-point improvement on the ADAS-Cog11 test after three months of treatment, compared to a 0.3-point improvement in the placebo group. The drug was particularly effective in improving cognition among high-risk APOE4 carriers.

How did buntanetap perform in Annovis Bio's Phase 3 Parkinson's Disease study?

In the Phase 3 Parkinson's Disease study, buntanetap led to significant improvements in both the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) and cognition across several PD subpopulations. It showed a strong response in individuals diagnosed with PD for more than three years and in those with postural instability and gait disorder (PIGD).

What was Annovis Bio's (ANVS) financial position at the end of Q2 2024?

As of June 30, 2024, Annovis Bio (ANVS) had $4.0 million in cash and cash equivalents. The company reported total operating expenses of $7.8 million for Q2 2024 and a net loss of $0.44 per share. After recent warrant exercises and ELOC share placements, the cash position improved to $12.1 million as of August 14, 2024.

What new developments did Annovis Bio announce regarding buntanetap's formulation?

Annovis Bio introduced a new crystalline form of buntanetap with improved properties, including better solubility and stability. This new form also provides an additional 20 years of patent life. The company filed a new composition of matter patent covering this novel crystal form and its use for treating various neurodegenerative conditions.