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Cognition Therapeutics Reports Year End 2022 Financial Results and Provides Business Update - Completed enrollment of CT1812 Phase 2 SEQUEL study for mild-to-moderate Alzheimer's disease - Received FDA clearance for Phas

Key Takeaway: Cognition Therapeutics, Inc. has reported its financial results for the year ending December 31, 2022, highlighting significant advancements in its clinical programs. They completed enrollment in the Phase 2 SEQUEL study for mild-to-moderate Alzheimer's disease and received FDA clearances for additional studies involving CT1812. The company also secured a commitment for up to $35 million in equity financing to support ongoing projects. Despite a net loss of $21.4 million for the year, Cognition aims to effectively execute its clinical agenda and capitalize on its momentum in 2023.

Market Sentiment Analysis

POSITIVE FACTORS

  • Completed enrollment of the Phase 2 SEQUEL study for Alzheimer's disease.
  • Received FDA clearance for multiple studies, enhancing development pipeline.
  • Secured equity commitment of up to $35 million, improving capital position.
  • Established a podcast series to engage with the neuroscience community.

CONCERNS & RISKS

  • The company reported a net loss of $21.4 million for the year.
  • Increased R&D expenses raise concerns about cost management.

Full Press Release Details

Cognition Therapeutics Reports Year End 2022
Financial Results and Provides Business Update
- Completed enrollment of CT1812 Phase 2 SEQUEL
study for mild-to-moderate Alzheimer's disease
- Received FDA clearance for Phase 2 START
Study of CT1812 in early Alzheimer's disease
Received FDA clearance for IND for Phase 2 study of CT1812 in 240 patients with geographic atrophy secondary to dry
- Secured equity commitment of up to an additional
$35M enabling potential access to capital
- Connecting with neuroscience community through
ongoing Cognition Conversations podcast series
- Call scheduled today at 8:00 a.m. ET to discuss
Purchase, NY - March 23,
2023 - Cognition Therapeutics, Inc. (Nasdaq: CGTX), a clinical-stage neuroscience company developing
drugs that treat neurodegenerative disorders by regulating cellular damage response pathways (the "Company" or "Cognition"),
today reported financial results for the fourth quarter and full year ended December 31, 2022, and provided a business update.
"We believe the momentum we built in 2022 positions us for further
success with our clinical and operational agenda in 2023," said Lisa Ricciardi, President and CEO of Cognition Therapeutics. "In
the fourth quarter of 2022, we saw improvement in all key aspects of our business. On the capital front, we raised $6 million in a follow-on
public offering, established an ATM program and, in the first quarter of 2023, secured up to an additional $35 million equity financing
commitment from Lincoln Park Capital. In the clinic, we expanded our mild-to-moderate Alzheimer's disease 144-patient SHINE study
to include sites in Europe and began dosing patients. During the same period, as part of our mission to educate stakeholders on our programs
and promote disease awareness, we launched a podcast series that features conversations with CNS experts and thought leaders to discuss
key developments in the neurodegenerative disease space."
"We kicked off 2023 announcing the completion of enrollment
in our Phase 2 SEQUEL study for mild-to-moderate Alzheimer's disease with topline results expected later this year," Ms. Ricciardi
continued. "We also received clearance from the US FDA to proceed with our 540-patient START study that will investigate the treatment
potential of CT1812 in early Alzheimer's disease and anticipate commencing the trial this year. Lastly, we recently obtained the
FDA's clearance on our IND application to pursue a Phase 2 study of CT1812 in 240 patients with geographic atrophy. Our extensive
non-dilutive grant funding supports the majority of our trials. Taken together, we believe we are in a position to efficiently execute
all of our set objectives across the business, and we look forward to delivering on our goals," concluded Ms. Ricciardi.
Financial Highlights:
Cognition Therapeutics, Inc.
Business and Corporate Highlights:
Cash and cash equivalents: On December 31, 2022, the Company's
cash balance was $41.6 million. The Company estimates that it has sufficient cash to fund operations and capital expenditures into the
second half of 2024.
For the year ended December 31,
2022, research and development expenses were $30.3 million compared to $18.6 million for 2021. The increase in the Company's R&D
expenses for 2022 was primarily attributable to an increase in clinical programs related to increased Phase 2 trial activity,
and an increase in associated personnel costs.
For the year ended December 31, 2022, general and administrative
expenses were $13.2 million compared to $10.0 million for the same period in 2021. The increase in general and administrative expenses
was primarily attributable to increased costs associated with being a public company.
For the year ended December 31, 2022, Cognition Therapeutics
reported a net loss of $21.4 million, or $0.91 per basic and diluted share, compared to a net loss of $11.7 million, or $3.13 per basic
and diluted share for 2021.
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 8663531. Alternatively, you may connect
to the live webcast via the link on the Investor Relations page of the Cognition website at www.cogrx.com.
The archived webcast will be available for 90 days beginning at approximately
9:30 a.m. ET, on Thursday, March 23, 2023.
Cognition Therapeutics, Inc.
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/
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 impact of the ongoing 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
For the Year Ended
(in thousands, except share and per share data) December 31,
Consolidated Statements of Operations Data: 2022 2021
Operating Expenses:
Research and development $ 30,324 $ 18,572
General and administrative 13,227 10,026
Total operating expenses 43,551 28,598
Loss from operations (43,551 ) (28,598 )
Other income (expense):
Grant income 22,217 17,447
Change in the fair value of the derivative liability - 2,209
Change in the fair value of the Simple Agreements for Future Equity - (2,236 )
Other expense, net (35 ) (88 )
Gain on debt extinguishment - 443
Interest expense (28 ) (893 )
Total other income, net 22,154 16,882
Net Loss (21,397 ) (11,716 )
Cumulative preferred stock dividends - (4,532 )
Net loss attributable to common stockholders $ (21,397 ) $ (16,248 )
Unrealized loss on foreign currency translation (1 ) (11 )
Total comprehensive loss $ (21,398 ) $ (11,727 )
Net loss per share:
Basic $ (0.91 ) $ (3.13 )
Diluted $ (0.91 ) $ (3.13 )
Weighted-average common shares outstanding:
Basic 23,640,199 5,190,883
Diluted 23,640,199 5,190,883
(in thousands) As of December 31,
Consolidated Balance Sheet Data: 2022 2021
Cash and cash equivalents $ 41,562 $ 54,721
Total assets 50,425 59,137
Total liabilities 10,176 7,864
Accumulated deficit (115,401 ) (94,004 )
Total stockholders' equity 40,249 51,273
Cognition Therapeutics, Inc.

Frequently Asked Questions

What is the focus of Cognition Therapeutics?

Cognition Therapeutics focuses on developing drugs for neurodegenerative disorders.

What recent studies has Cognition Therapeutics completed?

Cognition completed enrollment for the Phase 2 SEQUEL study in Alzheimer's patients.

How much capital has Cognition secured recently?

Cognition Therapeutics secured an equity commitment of up to $35 million.

What are the financial results for Cognition Therapeutics for 2022?

Cognition reported a net loss of $21.4 million for the year ended 2022.

When will Cognition host its conference call?

Cognition will host a conference call today at 8:00 a.m. ET.

Last updated: Mar 23, 2023