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Second Quarter 2022 Operational & Financial Results
Alpha Cognition, Inc. (OTC:ACOGF) released 2Q:22 operational and financial results on August 25, 2022 and concurrently filed its annual report with SEDAR.
Highlights for 2022 include:
➢ Preclinical histology data for Alpha-1062 in TBI - February 2022
➢ Preclinical data for Alpha-0602 announced – March 2022
➢ Addition of new CFO Don Kalkofen – April 2022
➢ Introduction of two new GEMs candidates: Alpha-0702 & Alpha-0802 – June 2022
➢ Pharmacokinetic equivalence study results for Alpha-1062 – June 2022
➢ Bioequivalence study results for Alpha-1062 – August 2022
For the second quarter of 2022 versus the same prior year period, both ending June 30.
➢ No revenues were generated in either period;
➢ Research and development expenses totaled $3.0 million, up 95% from $1.6 million on higher product development expenses, legal and patent costs and management fees and salaries related to Alpha-1062 and Alpha-0602, partially offset by lower consulting fees and share based compensation;
➢ General and administrative expenses doubled to $1.4 million from $704,000 on higher management fees and salaries, recognition of investor relations and marketing costs, greater professional fees, more share-based compensation, subcontractor and travel expenses;
➢ Total operating expenses rose 98% to $4.4 million from $2.2 million;
➢ Net other items were $1.4 million dominated by gain on revaluation of derivative liability related to warrants augmented by foreign exchange loss;
➢ Net loss was ($3.0) million vs. $154,0001 or ($0.04) and $0.00 per share, respectively.
As of June 30, 2022, cash and equivalents totaled $6.0 million. This amount compares to an $11.3 million balance at the end of December 2021. In terms of debt, Alpha Cognition carries a promissory note issued in March 2015 to Neurodyn Life Sciences for the acquisition of Alpha-1062 held on the balance sheet at $1.1 million. Cash used in operations for 2Q:22 was ($2.7) million compared with cash used of ($2.0) million in 2Q:21. Financing cash flows totaled ($6,000) related to interest paid on promissory notes.
Alpha-1062 Extended-Release Bioequivalence Study Topline Results
Results from the second bioequivalence study were shared with investors a few weeks ago on August 22, 2022. The data demonstrated pharmacokinetic equivalence between 5 mg of Alpha-1062 delayed release tablets and 8 mg galantamine hydrobromide extended release (ER) capsules. These results combined with the data released in June show that both approved formulations of galantamine hydrobromide fall within the parameters required for bioequivalence.
The study was a two-treatment, two-period crossover study that enrolled 40 healthy subjects evenly split between the Alpha-1062 5 mg b.i.d. arm and the 8mg q.d. ER capsule arm. Alpha-1062 achieved area-under-the-curve (AUC) and peak (CMAX) exposures of ~107% and ~127% respectively compared to results produced by galantamine hydrobromide ER. The CMAX results fell between the galantamine immediate release (IR) and ER results. The data will support the anticipated submission of the new drug application (NDA) targeted for 2Q:23.
Bioavailability and Bioequivalence Study Results
Alpha Cognition launched its pivotal bioavailability and bioequivalence studies in 2Q:22 which will each enroll 32 healthy adult subjects. The study design calls for a single dose of Alpha-1062 under both fed and fasted conditions. The hurdle for bioequivalence calls for a 90% confidence interval for pharmacokinetic parameters and area under the curve (AUC) and CMAX to fall between 80% and 125% of the standard.
ACI provided topline results from its bioavailability and bioequivalence (BABE) study in a June 22nd press release which was followed by a conference call providing additional detail along with a presentation summarizing key data. Results showed that Alpha-1062 (galantamine benzoate) presented a favorable side effect profile and was within the parameters for bioavailability and bioequivalence required by the FDA to grant approval via the 505(b)(2) regulatory pathway. Next steps are to prepare for the safety and tolerability study that will measure overall adverse events and specific side effects. The trial, designated RESOLVE, will be designed as a three-arm study comparing two arms of Alpha-1062 with placebo and enrolling 300 patients. Based on the data that is being developed, a New Drug Application (NDA) is expected to be filed for Alpha-1062 in Alzheimer's Disease (AD) by 2Q:23.
The two objectives of the BABE trial were to measure whether or not the bioequivalence of Alpha-1062 compared with the reference product fell within the limits required for AUC and CMAX. During the June 22nd conference call, Chief Medical Officer Cedric O'Gorman, M.D. provided a summary of the data generated from the studies which we include in the following exhibit. The bioequivalence limits given compare Alpha-1062 with galantamine hydrobromide immediate release formulation.
The data provided in the release support continued development of Alpha-1062. The safety profile of the drug was excellent with no serious adverse events (SAEs) in the active arm. The control arm evaluating galantamine hydrobromide IR was associated with two SAEs including diarrhea and vomiting, which were in-line with expectations based on the label for the reference drug. The main objective of Alpha-1062 with its prodrug formulation and enteric coating is to avoid many of the side effects common to approved formulations of galantamine which frequently cause patients to stop taking the drug, thereby failing to obtain its benefits. If Alpha Cognition's formulation of the drug can address these shortcomings, it is likely that the benefits that we elucidate in our initiation will be more broadly available for Alzheimer's patients.
RESOLVE Study
ACI met with the FDA during the second quarter to discuss Alpha-1062, specifically the RESOLVE trial, and related labeling and manufacturing. Based on the FDA's response, the company expects to file its NDA for Alpha-1062 in 2Q:23. The submission will include additional stability data. Preparation for the RESOLVE trial is underway with processes in place, engagement of data management support, site identification, evaluation and qualification. Institutional Review Board (IRB) approval has been granted and the final study protocol has been submitted via the Investigational New Drug (IND) application. The trial is expected to begin within a quarter of securing capital.
RESOLVE is a safety and tolerability trial designed to evaluate adverse events in comparison with a placebo that will evaluate 300 subjects. It will measure rates of overall adverse events and specific adverse events particular to galantamine including diarrhea, nausea, vomiting, insomnia and dizziness. The study will also assess the impact of standard and accelerated titration schedules on tolerability.
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1. Note: Our comparison uses results as originally reported for 2Q:21.
2. Source: Alpha Cognition Second Quarter 2022 SEDAR Filing, Management Discussion & Analysis.
3. Source: Alpha Cognition June 2022 Corporate Presentation.
4. Source: June 2022 Alpha Cognition Corporate Presentation.
5. Source: Alpha Cognition August 2022 Corporate Presentation.
