MALVERN, PA — Annovis Bio Inc. (NYSE: ANVS) has announced its financial results for the second quarter ending June 30, 2024, along with significant business updates. The company highlighted positive data from pivotal clinical trials and new patent filings.
CEO Maria Maccecchini commented, “The recent months have been productive for our company. 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. Buntanetap significantly improved cognition in patients with early AD, showing a 3.3-point improvement on the ADAS-Cog11 test after three months, compared to a 0.3-point improvement in the placebo group. Follow-up analysis on June 11, 2024, revealed further benefits for high-risk APOE4 carriers, with a 3.15-point improvement in cognition. Buntanetap was safe, showing no instances of Amyloid-Related Imaging Abnormalities (ARIA).
Parkinson’s Disease (PD):
On July 2, 2024, Annovis Bio announced Phase 3 PD study results. Buntanetap showed significant improvements in the Unified Parkinson’s Disease Rating Scale (MDS-UPDRS) and cognition, especially in patients diagnosed for more than three years and those with postural instability and gait disorder (PIGD). It halted cognitive decline and improved cognition in patients with mild dementia, similar to the AD study results.
Financial Performance
Annovis Bio received $7.1 million from exercises of Canaccord warrants in July 2024 and $7.0 million from an ELOC facility announced in April 2024. As of June 30, 2024, the company had cash and cash equivalents of $4.0 million, down from $5.7 million on December 31, 2023. Following recent warrant exercises and share placements, the cash balance increased to $12.1 million as of August 14, 2024. The company believes this will support operations through planned FDA meetings in the fall and the initiation of pivotal studies.
Operating expenses for Q2 2024 were $7.8 million, including $5.8 million in R&D and $2.0 million in G&A expenses, compared to $9.8 million in Q2 2023. Net loss for Q2 2024 was $0.44 per share, compared to $1.07 per share in Q2 2023.
Recent Developments and Patents
Annovis Bio introduced a new crystalline form of buntanetap, offering better solubility and stability, and filed a composition of matter patent for this new form, adding 20 years of patent life. The company also received FDA approval to continue Phase 3 development with the new crystal form and was granted a U.S. patent for buntanetap in treating acute traumatic brain injury.
Team Updates and Other Achievements
Annovis Bio expanded its team with key appointments, including Mark White as Chief Business Officer and Alexander Morin as Director of Strategic Communications. The company also published a scientific article on buntanetap’s pharmacokinetics and revealed new preclinical data showing cognitive improvement when combined with Trulicity®.
Pioneering Breakthroughs in Biotech Investment Opportunities
For investors, Annovis Bio’s recent clinical successes and strategic patent filings indicate strong growth potential. The new crystalline form of buntanetap and the positive trial results for Alzheimer’s and Parkinson’s treatments position the company for significant advancements. The company’s financial health and strategic developments make it a promising investment opportunity in the biotech sector.
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