Alpha Cognition Announces Fourth Quarter and Full Year 2021 Results and Company Update
VANCOUVER, B.C., April 28, 2022. Alpha Cognition Inc. (TSX-V: ACOG) (OTCQB: ACOGF) (“Alpha Cognition”, or the “Company”), a biopharmaceutical company committed to developing novel therapies with the potential to transform the lives of people with debilitating neurodegenerative disorders, today reported financial results for the fourth quarter and full year ended December 31, 2021.
"This past quarter and the year leading up to it has been a transformational period for Alpha Cognition," said Michael McFadden, the Company’s Chief Executive Officer. "We have delivered positive pre-clinical results for the ALPHA-1062 mild-TBI program and have delivered positive pre-clinical results for ALPHA-0602, our progranulin gene-therapy for ALS. The 2nd quarter will be eventful, with the company expected to report top-line results from the pivotal bioavailability and bioequivalence registration trials of ALPHA-1062 required for approval for the treatment of mild to moderate dementia of the Alzheimer’s type. Positive data will set the stage for a third quarter NDA submission. Our team continues to execute according to plan in this transformational year for the Company.”
Recent Program Developments
Mild to Moderate Dementia of the Alzheimer’s Type: ALPHA-1062 (galantamine benzoate) prodrug, delayed release oral tablet
- Alpha Cognition has initiated pivotal trials to demonstrate bioequivalence to the FDA-assigned reference listed drug, required for marketing approval. The trials are of a single dose, cross-over study design in both fed and fasted conditions. The Company plans to share topline results from the study in Q2 2022.
- Alpha Cognition intends to meet with the FDA to discuss the ongoing clinical development of ALPHA-1062 and a proposed Alzheimer’s disease tolerability and dosing trial which could allow for prescribing information changes post-approval. Pending regulatory feedback, the plan would be to initiate this study in late Q2 2022, with top line results expected in 2023.
Alpha Cognition Announced Positive Data from Pre-Clinical Studies of ALPHA-0602 (Progranulin) for Amyotrophic Lateral Sclerosis (ALS)
- The Company announced positive preclinical data from its ALPHA-0602 ALS gene therapy program. These data underscore the robust preclinical evidence supporting the Company’s AAV-based gene therapy approach to treating ALS and highlights the Company’s strategy to validate these data in planned clinical trials.
- Highlights of the positive proof of concept pre-clinical results demonstrated with ALPHA-0602 in vitro in motor neurons and in vivo in models of ALS, include:
- ALPHA-0602 demonstrated abundant PGRN expression in motor neurons, suggesting a neurotrophic role for PGRN. ALPHA-0602 further increased PGRN levels and decreased motor neuron cell death in in vitro models.
- Using an in vivo model of ALS to further assess the neurotrophic effects of PGRN, ALPHA-0602 reversed the motor neuron toxicity resulting from decreased levels of TDP-43 and FUS, and the expression of ALS related toxic forms of these proteins.
- In an ALS transgenic mouse model caused by a toxic form of TDP-43, Alpha-0602 administered via adeno-associated virus, resulted in successful viral transduction of CNS cells and substantially increased cerebrospinal fluid (CSF) levels of PGRN.
- ALPHA-0602-treated TDP-43 transgenic mice persistently gained weight throughout the 10-week study, in contrast to untreated transgenic animals who failed to gain weight. Continued weight gain in the face of a significant and sustained toxic insult, is suggestive of a therapeutic benefit of Alpha-0602 expression.
Alpha Cognition Announced Positive Data from a Pre-Clinical Study of ALPHA-1062 for Traumatic Brain Injury
- The Company announced functional data from the ALPHA-1062 Traumatic Brain Injury (TBI) program. ALPHA-1062 intranasal administration significantly reduced the extent of the functional deficit, and improved functional recovery of TBI animals compared to untreated animals suffering a TBI. Notably, in four of five functional measures of recovery, the performance of ALPHA-1062 treated group was statistically indistinguishable from that of the uninjured cohort.
- In a rodent model of TBI, ALPHA-1062 or vehicle (purified water as treatment control) was administered intranasally, with treatment initiated 2 hours after injury and continued twice daily for 35 days. ALPHA-1062 significantly:
- acutely limited the extent of motor deficit.
- improved motor and sensory functional recovery measured by motor skill assessment, sensory/motor skill assessment, and Modified Neurological Severity Score which comprises motor, sensory, balance and reflex assessments.
- Improved cognitive functional recovery measured by tests which assess recognition memory, and spatial learning and memory.
- The Company announced histology data from the intranasal ALPHA-1062 Traumatic Brain Injury (TBI) program. ALPHA-1062 treatment was neuroprotective, preserving hippocampal structure, reducing cell loss and promoting neurogenesis compared to no treatment. These histological results confirm the functional preservation/recovery data and taken together, strongly support the further development of ALPHA-1062 for the treatment of TBI.
Select Financial Information for Fourth Quarter and Full Year 2021:
(Expressed in United States Dollars)
- Research and development (R&D) expenses were $2.7 million for the three months ended December 31, 2021, and $8.0 million for the year ended December 31, 2021, up from $1.2 million and $4.7 million in the same periods in 2020, respectively. R&D expenses increased in 2021 primarily due to the additional costs associated with advancing ALPHA-1062 and ALPHA-0602 clinical and preclinical studies.
- General and administrative (G&A), excluding non-cash expenses relating to accretion, amortization, depreciation, and share-based compensation, were $1.0 million for the three months ended December 31, 2021, and $2.6 million for the year ended December 31, 2021, up from $0.4 million and $0.9 million in the same period of 2020, respectively. The increase in G&A expenses in 2021 primarily related to professional fees, insurance costs and employee compensation related expenses, supporting the growth in our operations.
- The fourth quarter 2021 net loss was $3.2 million, or a net loss of $0.07 per share, and for the year ended December 31, 2021, net loss was $19.7 million, or a net loss of $0.37 per share, compared to the fourth quarter of 2020 net loss of $1.6 million, or a net loss of $0.04 per share, and for the year ended December 31, 2020, net loss of $5.8 million, or a net loss of $0.13 per share.
- Cash, cash equivalents as of December 31, 2021, were $11.3 million.
- Shares of common stock outstanding at December 31, 2021 were 60,606,931.
About Alpha Cognition Inc.
Alpha Cognition Inc. is a clinical stage, biopharmaceutical company dedicated to developing treatments for under-served neurodegenerative diseases, such as Alzheimer's Dementia and Amyotrophic Lateral Sclerosis (ALS).
ALPHA-1062, is a patented new chemical entity that has demonstrated safety and improved tolerability in human clinical trials. It is being developed as a new generation acetylcholinesterase inhibitor for the treatment of Alzheimer's disease, with minimal gastrointestinal side effects and novel routes of administration. ALPHA-1062's active metabolites are differentiated from donepezil and rivastigmine in that they may sensitize neuronal nicotinic receptors, most notably the alpha-7 subtype, which is known to have a positive effect on cognition. ALPHA-1062 is also being developed in combination with memantine to treat moderate to severe Alzheimer's dementia and in a nasal spray formulation to treat traumatic brain injury.
ALPHA-0602 (Progranulin) is expressed in several cell types in the central nervous system and in peripheral tissues, regulates cell survival and certain inflammatory processes, and plays a major role in regulating lysosomal function and microglial responses to disease. Its use for the treatment of neurodegenerative diseases has been patented by the Company and granted an Orphan Drug Designation.
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