ADDED
If we fail to comply with our obligations in the agreements under which we license intellectual property and other rights from third parties or otherwise experience disruptions to our business relationships with the University of South Florida Research Foundation, we could lose license rights that are important to our business.
If we do not continue to satisfy the Nasdaq Capital Market continued listing requirements, our common stock could be delisted from the Nasdaq Capital Market.
Far too many individuals, including patients and caregivers, suffer from the burden created by these devastating, and often fatal, diseases.
Alzheimer s is also the seventh leading cause of death (in 2021 and 2022) in the United States ( U.S.
will be $384 billion, including $246 billion in Medicare and Medicaid payments.
Our most advanced product candidate (lead product), which is licensed and in clinical development in humans, is AL001, an ionic cocrystal of lithium for the treatment of Alzheimer s, BD, MDD and PTSD.
We completed the clinical portion of the Phase IIA MAD clinical trial in March 2023, reported topline data in June 2023 and announced full data in October 2024.
Additionally, we are investigating the potential of AL001 for patients suffering from BD, MDD and PTSD, and submitted several Investigational New Drug ( IND ) applications to the FDA for these indications and received a study may proceed letter from the FDA for each.
In August 2024, we announced a partnership with Massachusetts General Hospital ( MGH ) and Harvard Medical School to conduct five Phase II imaging clinical trials.
The purpose of these trials is to assess the comparative increase in lithium levels within the brain and its structures as opposed to a commonly marketed lithium salt among healthy subjects and patients afflicted with Alzheimer s, BD, MDD and PTSD.
REMOVED
If we fail to comply with our obligations in the agreements under which we license intellectual property and other rights from third parties or otherwise experience disruptions to our business relationships with the Licensor, we could lose license rights that are important to our business.
If we do not regain compliance with or continue to satisfy the Nasdaq Capital Market continued listing requirements, our common stock could be delisted from the Nasdaq Capital Market.
The concentration of our stock ownership will limit your ability to influence corporate matters, including the ability to influence the outcome of director elections and other matters requiring stockholder approval.
Far too many individuals, patients and caregivers suffer from the burden created by these devastating, and often fatal, diseases.
Alzheimer s is also the seventh leading cause of death (in 2020 and 2021) in the United States ( U.S.
will be $360 billion, including $231 billion in Medicare and Medicaid payments.
Our most advanced product candidate (lead product) is licensed and in clinical development in humans is AL001, an ionic cocrystal of lithium for the treatment of Alzheimer s, BD, MDD and PTSD.
We completed the clinical portion of the Phase IIA MAD clinical trial in March 2023 and reported topline data in June 2023.
Additionally, we are investigating the potential of AL001 for patients suffering from BD, MDD and PTSD, and submitted several Investigational New Drug ( IND ) applications to the FDA for these indications: (i) the IND for BD was submitted in August 2023 and we received a study may proceed letter from the FDA in September 2023; (ii) the IND for MDD was submitted in October 2023 and we received a study may proceed letter from the FDA in November 2023; and (iii) the IND for PTSD was submitted in November 2023 and we received a study may proceed from the FDA in December 2023.
In April 2023, we initiated a Phase I/IIA clinical trial for ALZN002 to treat mild to moderate dementia of the Alzheimer s type.