Full Press Release Details
Therapeutics Reports Financial Results for the Second Quarter 2024 and Provides Business
Phase 2 SHINE Trial Demonstrates ~40% Mean Improvement in ADAS-Cog 11 vs Placebo and Consistent Positive Changes Across Multiple Cognitive
and Functional Measures -
Report Topline Results from SHIMMER Study in Mild-to-Moderate DLB by YE 2024 -
Host Investor Conference Call at 8:30 a.m. -
NY - August 8, 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 second quarter ended June 30, 2024, and provided a business update.
announced favorable results from the Phase 2 SHINE' Study that provided proof-of-concept that CT1812 has potential to slow
the progression of mild-to-moderate Alzheimer's disease after just six months of treatment," said Lisa
Ricciardi, Cognition's president and CEO. "In terms of next steps, we are looking forward to reading out results from our
SHIMMER' study in mild-to-moderate dementia with Lewy bodies by year-end 2024 and are now planning the next phase of development
in our Alzheimer's disease program."
Business and Corporate Highlights
Second Quarter 2024 Financial Results
and cash equivalents as of June 30, 2024 were approximately $28.5 million and total grant funds remaining from the NIA were $57.3
million. The Company estimates that it has sufficient cash to fund operations and capital expenditures
into the second quarter of 2025.
Research and development expenses were
$11.6 million for the second quarter ended June 30, 2024, compared to $8.5 million for the comparable period in 2023. The increase
was primarily related to higher costs associated with advancing our clinical programs, including Phase 2 trial activities with contract
research organizations and personnel cost.
General and administrative expenses
were $3.1 million for the second quarter ended June 30, 2024, compared to $3.3 million for the comparable period in 2023. The decrease
was primarily related to lower professional services.
The Company reported a net loss of $7.0
million, or $(0.18) per basic and diluted share for the second quarter ended June 30, 2024, compared to a net loss of $4.7 million,
or $(0.16) per basic and diluted share for the same period in 2023.
| Date / Time | August 8, 2024 at 8:30am ET / 5:30am PT |
| Telephone Access: | US/Canada Participant Toll-Free Dial-in Number: (800) 715-9871 US/Canada Participant International Dial-In Number: (646) 307-1963 Conference ID Number: 3702003 |
| Webcast Access: | The audio webcast with live Q&A will be accessible at https://edge.media-server.com/mmc/p/3napeebe or via the Investor Relations section of Cognition's website. An archive of the webcast and presentation will be available for 90 days beginning at approximately 10:30 a.m. ET on August 8, 2024. |
* CT1812 did not achieve statistical
significance on ADAS-Cog 11, the first of the ordered secondary efficacy endpoints, in the pooled 100mg and 300mg dose group compared
About Cognition Therapeutics:
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
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 our product candidates, including CT1812, and any expected
or implied benefits or results, including that initial clinical results observed with respect to CT1812 will be replicated in late trials
and our clinical development plans, including statements regarding our clinical studies of CT1812 and any analyses of the results therefrom,
the timing and expected results of our clinical trials, upcoming presentations on 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: 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; 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; 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.
| (in thousands, except share and per share data amounts) | Three Months Ended June 30, | Six Months Ended June 30, | ||||||||||||||
| Consolidated Statements of Operations Data: | 2024 | 2023 | 2024 | 2023 | ||||||||||||
| Operating Expenses: | ||||||||||||||||
| Research and development | $ | 11,577 | $ | 8,497 | $ | 22,130 | $ | 13,927 | ||||||||
| General and administrative | 3,101 | 3,320 | 6,650 | 6,863 | ||||||||||||
| Total operating expenses | 14,678 | 11,817 | 28,780 | 20,790 | ||||||||||||
| Loss from operations | (14,678 | ) | (11,817 | ) | (28,780 | ) | (20,790 | ) | ||||||||
| Other income (expense): | ||||||||||||||||
| Grant income | 7,311 | 6,925 | 12,223 | 10,351 | ||||||||||||
| Other income (expense), net | 333 | 172 | 577 | (443 | ) | |||||||||||
| Interest expense | (7 | ) | (6 | ) | (17 | ) | (16 | ) | ||||||||
| Loss on currency translation from liquidation of subsidiary | - | - | (195 | ) | - | |||||||||||
| Total other income, net | 7,637 | 7,091 | 12,588 | 9,892 | ||||||||||||
| Net loss | $ | (7,041 | ) | $ | (4,726 | ) | $ | (16,192 | ) | $ | (10,898 | ) | ||||
| Foreign currency translation adjustment, including reclassifications | - | (1 | ) | 195 | 3 | |||||||||||
| Total comprehensive loss | $ | (7,041 | ) | $ | (4,727 | ) | $ | (15,997 | ) | $ | (10,895 | ) | ||||
| Net loss per share: | ||||||||||||||||
| Basic | $ | (0.18 | ) | $ | (0.16 | ) | $ | (0.44 | ) | $ | (0.37 | ) | ||||
| Diluted | $ | (0.18 | ) | $ | (0.16 | ) | $ | (0.44 | ) | $ | (0.37 | ) | ||||
| Weighted-average common shares outstanding: | ||||||||||||||||
| Basic | 40,062,954 | 29,614,822 | 36,899,112 | 29,356,144 | ||||||||||||
| Diluted | 40,062,954 | 29,614,822 | 36,899,112 | 29,356,144 |
| As of | ||||||||
| (in thousands) | June 30, 2024 | December 31, 2023 | ||||||
| Consolidated Balance Sheet Data: | ||||||||
| Cash and cash equivalents | $ | 28,533 | $ | 29,922 | ||||
| Total assets | 34,369 | 35,163 | ||||||
| Total liabilities | 11,360 | 10,689 | ||||||
| Accumulated deficit | (157,381 | ) | (141,189 | ) | ||||
| Total stockholders' equity | 23,009 | 24,474 |