Alpha Cognition Announces Second Quarter and Six Months Ended 2023 Results and Provides Corporate Update
- Impending submission of NDA for ALPHA-1062 marks significant milestone
- On track to file NDA in Q3 2023
- Received pediatric and small business waivers
- USPTO issued Notice of Allowance for patent application
- Met with FDA for TBI program
- Awarded $750,000 R&D grant from Department of Defense
- Closing of initial tranche of PPM financing
- None.
Not for distribution in the
"As we approach a pivotal moment in our journey, the impending submission of our NDA marks a significant milestone for Alpha Cognition. Our dedicated team has tirelessly advanced our lead product, navigating complex research challenges, and has managed development challenges with unwavering determination. We stand on the cusp of a new chapter, confident in the strength of our data and the expertise that underpins our submission. The Company remains on track to file our NDA during the third quarter. We believe that ALPHA-1062 will offer a meaningful differentiated therapy for patients with Alzheimer’s dementia," said Michael McFadden, the Company’s Chief Executive Officer.
Corporate Updates
Alpha Cognition continues progress its new drug application (NDA) for ALPHA-1062 in mild-to-moderate Alzheimer’s disease (“AD”) which it expects to submit to FDA in September 2023. If the NDA file is accepted by the FDA, it would put Alpha Cognition on track for product approval during the third quarter of-2024. If approved, ALPHA-1062 would be one of three products approved by the FDA for the symptom treatment of Alzheimer’s disease in the last fifteen years. The Company believes a well tolerated medicine with limited adverse events offers a significant benefit to patients and caregivers.
The Company received it’s pediatric waiver and small business waiver during the quarter. This provides clarity for future financial and clinical requirements for the company. The small business waiver provides the company user fee exemptions and reductions in fees, and the pediatric waiver removes the Company’s obligations for future pediatric studies.
The Company announced the United States Patent and Trademark Office (USPTO) has issued a Notice of Allowance for patent application No. 17/575,025, titled “Solid Forms of ALPHA-1062 Gluconate,” which includes claims covering protection for crystalline solid forms of ALPHA-1062 and will bolster existing patents that the Company holds. A Notice of Allowance is issued after the USPTO makes the determination that a patent should be granted from an application. This Notice of Allowance signifies a pivotal step forward in the Company’s journey and is the result of years of relentless research and development, conducted by Alpha Cognition's team of esteemed scientists, researchers, and medical experts. ALPHA-1062 represents a breakthrough in the neurology market, offering a novel approach to addressing the symptomatic treatment of Alzheimer’s Disease.
For the Company’s TBI program, the Company met with the FDA in a pre-IND meeting for ALPHA-1062 Intranasal (“ALPHA-1062IN”) for Cognitive Impairment with TBI, where the Company sought alignment with FDA on a number of manufacturing, pre-clinical, and clinical matters, which would lead to an IND file. The FDA grants INDs when all preclinical work is completed to enter into human subjects. The FDA indicated during this meeting that the Company should complete additional toxicity work to align with the contemplated Phase 2 trial the Company has proposed, and complete additional manufacturing work which the Company had anticipated would be required as part of normal development and manufacturing controls. The Company expects Alpha Seven Therapeutics (see TBI out-licensing discussion below) will initiate the additional toxicity direct manufacturing and manufacturing work, which would be anticipated to complete in 2H, 2024. Alpha Seven Therapeutics would then be in the position to file an IND for ALPHA-1062IN.
Awarded Department of Defense
On June 5, 2023, the Company was awarded a
PPM Financing Closing of Initial Tranche
On May 30, 2023, the Company announced a best-efforts private placement offering of up to
In connection with the offering the Company entered into an Investment Banking Agreement (“IBA”) with Spartan Capital Securities, LLC (“Spartan”), pursuant to which Spartan will act as agent on a best-efforts basis. The Company and Spartan also entered into a consulting agreement pursuant to which Spartan agreed to provide consulting services for a three-year term. The services will include advising and assisting on potential business development transactions, strategic introductions, assisting management with enhancing corporate and shareholder value, and capital raising advice.
This news release does not constitute an offer to sell or a solicitation of an offer to buy any of the securities in
TBI Out-Licensing Plan
The Company has been working to out-license to a newly formed private entity, Alpha Seven Therapeutics, Inc. (“Alpha Seven”) which will develop ALPHA-1062IN for applications in traumatic brain injury. Spartan has agreed to act as agent, on a best efforts basis, for identifying financing for Alpha Seven Company in exchange for an initial
Alpha Seven will focus on the advancement of ALPHA-1062IN initially for the treatment of Cognitive Impairment with mTBI using an intra-nasal formulation, including advancing clinical trials with the goal of FDA approval. The establishment of Alpha Seven Therapeutics is expected to provide for separate funding and advancement of the TBI applications of ALPHA-1062IN while permitting Alpha Cognition to remain focused on advancing ALPHA-1062 for use in the treatment of symptoms of Alzheimer’s disease. If successful, the Alpha Seven’s advancement of this program in 2023 will allow for potential upcoming inflection points including IND acceptance and first patient enrolled in Ph2 trial during 2H 2023 and in 2024 Last patient enrolled followed by initial Phase 2 clinical results.
The Company received shareholder approval of the TBI out-licensing plan at its annual shareholder meeting held on June 27, 2023.
This news release does not constitute an offer to sell or a solicitation of an offer to buy any of the securities in
Financial Highlights for Second Quarter and Six months ended June 30, 2023
(Expressed in
-
Research and development (R&D) expenses were
$1.3 million $2.4 million $3.0 million $4.8 million -
General and administrative (G&A), excluding non-cash expenses relating to accretion, amortization, depreciation, and share-based compensation, were
$0.6 million $1.3 million $1.0 million $1.8 million -
The Company recorded a loss on revaluation derivative liability for the three months ended June 30, 2023, of
$0.1 million $0.0 million $1.3 million $1.4 million -
Share-based compensation under general and administrative was
$0.8 million $1.0 million $0.4 million $0.7 million -
The Company incurred foreign exchange gain/losses of
$0.0 million $0.0 million $0.1 million $0.1 million -
The second quarter of 2023 net loss was
$2.7 million $0.03 $4.6 million $0.05 $3.4 million $0.05 $6.1 million $0.09 -
Cash and cash equivalents at June 30, 2023 were
$1.2 million - Shares of common stock outstanding at June 30, 2023 were 87,950,664.
About Alpha Cognition Inc.
Alpha Cognition Inc. is a clinical stage, biopharmaceutical company dedicated to developing treatments for patients suffering from neurodegenerative diseases, such as Alzheimer’s disease and Cognitive Impairment with mild Traumatic Brain Injury (“mTBI”), for which there are currently no approved treatment options.
ALPHA-1062, is a patented new chemical entity being developed as a new generation acetylcholinesterase inhibitor for the treatment of Alzheimer’s disease, with expected minimal gastrointestinal side effects. ALPHA-1062’s active metabolite is differentiated from donepezil and rivastigmine in that it binds 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 as an intranasal formulation for Cognitive Impairment with mTBI.
Neither Canadian Securities Exchange (the “CSE”) or the OTC Markets Group, accepts responsibility for the adequacy or accuracy of this release.
Forward-looking Statements
This news release includes forward-looking statements within the meaning of applicable securities laws. Except for statements of historical fact, any information contained in this news release may be a forward‐looking statement that reflects the Company’s current views about future events and are subject to known and unknown risks, uncertainties, assumptions and other factors that may cause the actual results, levels of activity, performance or achievements to be materially different from the information expressed or implied by these forward-looking statements. In some cases, you can identify forward‐looking statements by the words “may,” “might,” “will,” “could,” “would,” “should,” “expect,” “intend,” “plan,” “objective,” “anticipate,” “believe,” “estimate,” “predict,” “project,” “potential,” “target,” “seek,” “contemplate,” “continue” and “ongoing,” or the negative of these terms, or other comparable terminology intended to identify statements about the future. Forward‐looking statements may include statements regarding the TBI out-licensing plan and associated financing, the availability of funding pursuant to financings, the Company’s business strategy, market size, potential growth opportunities, capital requirements, clinical development activities, the timing and results of clinical trials, regulatory submissions, potential regulatory approval and commercialization of the Company’s products. Although the Company believes to have a reasonable basis for each forward-looking statement, we caution you that these statements are based on a combination of facts and factors currently known by us and our expectations of the future, about which we cannot be certain. The Company cannot assure that the actual results will be consistent with these forward-looking statements. These forward‐looking statements speak only as of the date of this news release and the Company undertakes no obligation to revise or update any forward‐looking statements for any reason, even if new information becomes available in the future.
| Condensed Consolidated Statements of Operations | |||||||||||||||||
| (expressed in |
|||||||||||||||||
| Three months ended June 30, | Six months ended June 30, | ||||||||||||||||
2023 |
2022 |
2023 |
2022 |
||||||||||||||
| Operating expenses | $ |
(2,752,599 |
) |
$ |
(4,417,993 |
) |
$ |
(4,756,539 |
) |
$ |
(7,360,315 |
) |
|||||
| Other income (expenses) |
|
(38,155 |
) |
|
1,414,160 |
|
|
104,313 |
|
|
1,443,158 |
|
|||||
| Net loss for the year |
|
(2,790,754 |
) |
|
(3,003,833 |
) |
|
(4,652,226 |
) |
|
(5,917,157 |
) |
|||||
| Currency translation adjustment |
|
27,898 |
|
|
(376,526 |
) |
|
(8,341 |
) |
|
(176,449 |
) |
|||||
| Comprehensive loss | $ |
(2,762,856 |
) |
$ |
(3,380,359 |
) |
$ |
(4,660,567 |
) |
$ |
(6,093,606 |
) |
|||||
| Basic and diluted loss per common share | $ |
(0.03 |
) |
$ |
(0.05 |
) |
$ |
(0.05 |
) |
$ |
(0.09 |
) |
|||||
| Weighted average shares |
|
94,605,510 |
|
|
68,023,450 |
|
|
86,273,053 |
|
|
67,920,089 |
|
|||||
| Selected Consolidated Balance Sheet Data | |||||||||||||||||
| (expressed in |
|||||||||||||||||
| June 30, | December 31, | ||||||||||||||||
2023 |
2022 |
||||||||||||||||
| Cash | $ |
1,217,771 |
|
$ |
2,083,696 |
|
|||||||||||
| Working capital (deficiency) | $ |
326,858 |
|
$ |
(1,724,103 |
) |
|||||||||||
| Total assets | $ |
1,915,677 |
|
$ |
2,950,951 |
|
|||||||||||
| Total long-term liabilities | $ |
1,373,347 |
|
$ |
214,284 |
|
|||||||||||
View source version on businesswire.com: https://www.businesswire.com/news/home/20230822509181/en/
Michael McFadden, CEO
Tel: 1-858-344-4375
info@alphacognition.com
https://www.alphacognition.com/
Source: Alpha Cognition Inc.
