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Cognition Therapeutics Reports Year End 2023 Financial Results and Provides Business Update - Topline Results from SHINE Study in Mild-to-Moderate Alzheimer's Expected mid-2024 - - On Track to Report Topline Results from

Key Takeaway: Cognition Therapeutics has released their Year End 2023 financial results and business update, highlighting significant accomplishments in clinical studies focused on neurodegenerative disorders. The SHINE study's topline results for mild-to-moderate Alzheimer's disease are anticipated in mid-2024, while the SHIMMER study in mild-to-moderate dementia with Lewy bodies is set for the second half of 2024. The company has successfully raised capital to extend its operational runway and reported a net loss increase, reflecting ongoing investments in research and development.

Market Sentiment Analysis

POSITIVE FACTORS

  • Cognition Therapeutics achieved several important clinical milestones in 2023.
  • The company plans to report topline results from two significant studies in 2024.
  • Recent financing has strengthened the company's cash runway, allowing for continued operations.

CONCERNS & RISKS

  • The net loss for 2023 increased compared to the previous year.
  • The company mentions risks associated with clinical trials and funding.

Full Press Release Details

Cognition Therapeutics Reports Year End 2023
Financial Results and Provides Business Update
- Topline Results from SHINE Study in Mild-to-Moderate
Alzheimer's Expected mid-2024 -
- On Track to Report Topline Results from SHIMMER
Study in Mild-to-Moderate DLB in 2H 2024 -
- 1Q 2024 Capital Raise Extends Cash Runway
- Webcast Conference Call Scheduled Today at
Purchase, NY - March 26, 2024 - Cognition Therapeutics,
Inc. (Nasdaq: CGTX), a clinical stage company developing product candidates that
treat neurodegenerative disorders, (the "Company" or "Cognition"), today reported financial results for
the fourth quarter and full year ended December 31, 2023, and provided a business update. Management will host a live webcast conference
call at 8:00am ET to review 2023 accomplishments. Details of the call are provided below.
A number of important clinical milestones were achieved in 2023, including
the completion of enrollment in the Company's Phase 2 SHINE Study in people with mild-to-moderate Alzheimer's disease. In
addition, the company initiated clinical studies in early Alzheimer's disease and dry age-related macular degeneration (dry AMD).
Cognition scientists published two manuscripts and made 11 presentations at medical and scientific congresses in 2023, advancing the understanding
of its foundational science and clinical implications.
"We achieved a number of critical clinical objectives in 2023,"
said Lisa Ricciardi, Cognition's president and CEO. "We are pleased with the progress being made with our clinical trial partners
to advance our Phase 2 studies. In addition, the scientific data generated by our team has continued to provide insights into proteins
and biological processes impacted by CT1812 in Alzheimer's and Parkinson's diseases as well as dry AMD."
2023 Corporate and Clinical Highlights:
Cognition Therapeutics, Inc.
"The FDA approval in 2023 of the first disease-modifying
biologics for Alzheimer's disease was a much-needed advance for the development of new drugs to treat Alzheimer's and
other neurological conditions," said Ms. Ricciardi. "The approval confirmed the role of A oligomers and
protofibrils as disease drivers, re-invigorated research into complementary therapeutic approaches, and re-established investment
interest in the sector. Building on this momentum, Cognition looks forward to two key milestones in 2024, namely the topline readout
from two Phase 2 studies: SHINE in mild-to-moderate Alzheimer's disease and SHIMMER in mild-to-moderate DLB. In addition to
cognitive findings, samples from study participants will be analyzed with an expectation that candidate biomarkers of CT1812
activity can be identified. We expect these clinical and biomarker results will inform the next phase of our evolution."
Recent 2024 Financing
In March 2024, the Company issued and sold 6,571,428 shares of its
common stock in an underwritten follow-on public offering, at $1.75 per share. The Company received net proceeds of approximately $10.4
million after deducting underwriting discounts and commissions and estimated offering expenses.
2023 Financial Results
Cash and cash equivalents as of December 31, 2023, were approximately
$29.9 million, and total grant funds remaining from the NIA were $67.5 million. With the additional capital from the March 2024 offering,
the Company estimates that it has sufficient cash to fund operations and capital expenditures through May of 2025.
Research and development expenses were $37.2 million for the year ended
December 31, 2023, compared to $30.3 million for 2022. The increase was primarily related to higher costs associated with Phase 2 trial
activities with contract research organizations, personnel, and preclinical research, partially offset by decreased manufacturing costs.
General and administrative expenses were $13.5 million for the year
ended December 31, 2023, compared to $13.2 million for 2022. The increase was primarily related to higher employee compensation and benefits
driven by increased headcount and equity-based compensation, partially offset by decreased Director & Officer Liability insurance
The Company reported a net loss of $25.8 million, or $(0.86) per basic
and diluted share for the year ended December 31, 2023, compared to a net loss of $21.4 million, or $(0.91) per basic and diluted
Conference Call Information
Management will host a conference call and live webcast to discuss
Cognition's financial results today at 8:00 a.m. ET. To participate in the conference call, dial (800) 715-9871 (U.S.) or (646)
307-1963 (international) and provide conference ID number 6295507. Alternatively, you may connect to the live webcast via this link: https://edge.media-server.com/mmc/p/q7djwfy4
or by visiting the Investor Relations page of the Cognition website at www.cogrx.com. An archived webcast recording will be available
approximately one hour after the conclusion of the live call.
About Cognition Therapeutics:
Cognition Therapeutics,
Inc. is a clinical-stage biopharmaceutical company engaged in the discovery and development of innovative, small molecule
therapeutics targeting age-related degenerative disorders of the central nervous system and retina. We are currently investigating
our lead candidate CT1812 in clinical programs in Alzheimer's disease, dementia
with Lewy bodies (DLB) and dry age-related macular degeneration (dry AMD). We believe CT1812 and our pipeline of -2 receptor
modulators can regulate pathways that are impaired in these diseases. We believe that targeting the -2 receptor with CT1812
represents a mechanism functionally distinct from other current approaches in clinical development for the treatment of
degenerative diseases. More about Cognition Therapeutics and its pipeline can be found at https://cogrx.com/.
Cognition Therapeutics, Inc.
Forward-Looking Statements
This press release contains forward-looking
statements within the meaning of The Private Securities Litigation Reform Act of 1995. All statements contained in this press release,
other than statements of historical facts or statements that relate to present facts or current conditions, are forward-looking statements.
These statements, including statements relating to the timing and expected results of our clinical trials, and cash runway, involve known
and unknown risks, uncertainties and other important factors that may cause our actual results, performance, or achievements to be materially
different from any future results, performance, or achievements expressed or implied by the forward-looking statements. In some cases,
you can identify forward-looking statements by terms such as "may," might," "will," "should,"
"expect," "plan," "aim," "seek," "anticipate," "could," "intend,"
"target," "project," "contemplate," "believe," "estimate," "predict,"
"forecast," "potential" or "continue" or the negative of these terms or other similar expressions.
We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends
that we believe may affect our business, financial condition, and results of operations. These forward-looking statements speak only as
of the date of this press release and are subject to a number of risks, uncertainties and assumptions, some of which cannot be predicted
or quantified and some of which are beyond our control. Factors that may cause actual results to differ materially from current expectations
include, but are not limited to: competition; our ability to secure new (and retain existing) grant funding; our ability to grow and manage
growth, maintain relationships with suppliers and retain our management and key employees; our ability to successfully advance our current
and future product candidates through development activities, preclinical studies and clinical trials and costs related thereto; uncertainties
inherent in the results of preliminary data and pre-clinical studies being predictive of the results of clinical trials; the timing, scope
and likelihood of regulatory filings and approvals, including regulatory approval of our product candidates; changes in applicable laws
or regulations; the possibility that the we may be adversely affected by other economic, business or competitive factors, including ongoing
economic uncertainty; our estimates of expenses and profitability; the evolution of the markets in which we compete; our ability to implement
our strategic initiatives and continue to innovate our existing products; our ability to defend our intellectual property; the impacts
of ongoing global and regional conflicts; the impact of the COVID-19 pandemic on our business, supply chain and labor force; and the risks
and uncertainties described in the "Risk Factors" section of our annual and quarterly reports filed the Securities Exchange
Commission. These risks are not exhaustive and we face both known and unknown risks. You should not rely on these forward-looking statements
as predictions of future events. The events and circumstances reflected in our forward-looking statements may not be achieved or occur,
and actual results could differ materially from those projected in the forward-looking statements. Moreover, we operate in a dynamic industry
and economy. New risk factors and uncertainties may emerge from time to time, and it is not possible for management to predict all risk
factors and uncertainties that we may face. Except as required by applicable law, we do not plan to publicly update or revise any forward-looking
statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise.
Cognition Therapeutics, Inc.
Cognition Therapeutics, Inc.
Unaudited Selected Financial Data
(in thousands, except share and per share data) For the Year Ended December 31,
Consolidated Statements of Operations Data: 2023 2022
Operating Expenses:
Research and development $ 37,196 $ 30,324
General and administrative 13,528 13,227
Total operating expenses 50,724 43,551
Loss from operations (50,724 ) (43,551 )
Other income (expense):
Grant income 24,805 22,217
Other income (expense), net 158 (35 )
Interest expense (27 ) (28 )
Total other income, net 24,936 22,154
Net loss $ (25,788 ) $ (21,397 )
Unrealized gain (loss) on foreign currency translation 4 (1 )
Total comprehensive loss $ (25,784 ) $ (21,398 )
Net loss per share:
Basic $ (0.86 ) $ (0.91 )
Diluted $ (0.86 ) $ (0.91 )
Weighted-average common shares outstanding:
Basic 30,029,087 23,640,199
Diluted 30,029,087 23,640,199
As of
(in thousands) December 31, 2023 December 31, 2022
Consolidated Balance Sheet Data:
Cash and cash equivalents $ 29,922 $ 41,562
Total assets 35,163 50,425
Total liabilities 10,689 10,176
Accumulated deficit (141,189 ) (115,401 )
Total stockholders' equity 24,474 40,249

Frequently Asked Questions

What are the key results from the SHINE Study?

Topline results from the SHINE Study in mild-to-moderate Alzheimer's are expected in mid-2024.

When will the SHIMMER study results be reported?

Topline results from the SHIMMER Study in mild-to-moderate DLB are anticipated in the second half of 2024.

What was Cognition Therapeutics' net loss for 2023?

Cognition Therapeutics reported a net loss of $25.8 million for the year ended December 31, 2023.

How much cash did Cognition Therapeutics have at the end of 2023?

As of December 31, 2023, Cognition Therapeutics had approximately $29.9 million in cash and equivalents.

What new studies did Cognition initiate in 2023?

Cognition initiated studies in early Alzheimer's disease and dry age-related macular degeneration.

Last updated: Mar 26, 2024