– Accomplished enrollment of CT1812 Section 2 SEQUEL examine for mild-to-moderate Alzheimer’s illness
– Obtained FDA clearance for Section 2 START Research of CT1812 in early Alzheimer’s illness
– Obtained FDA clearance for IND for Section 2 examine of CT1812 in 240 sufferers with geographic atrophy secondary to dry AMD
– Secured fairness dedication of as much as an extra $35M enabling potential entry to capital
– Connecting with neuroscience neighborhood via ongoing Cognition Conversations podcast collection
– Name scheduled immediately at 8:00 a.m. ET to debate outcomes
PURCHASE, N.Y., March 23, 2023 (GLOBE NEWSWIRE) — Cognition Therapeutics, Inc. (Nasdaq: CGTX), a clinical-stage neuroscience firm growing medicine that deal with neurodegenerative problems by regulating mobile harm response pathways (the “Firm” or “Cognition”), immediately reported monetary outcomes for the fourth quarter and full 12 months ended December 31, 2022, and supplied a enterprise replace.
“We imagine the momentum we inbuilt 2022 positions us for additional success with our medical and operational agenda in 2023,” mentioned Lisa Ricciardi, President and CEO of Cognition Therapeutics. “Within the fourth quarter of 2022, we noticed enchancment in all key points of our enterprise. On the capital entrance, we raised $6 million in a follow-on public providing, established an ATM program and, within the first quarter of 2023, secured as much as an extra $35 million fairness financing dedication from Lincoln Park Capital. Within the clinic, we expanded our mild-to-moderate Alzheimer’s illness 144-patient SHINE examine to incorporate websites in Europe and commenced dosing sufferers. Throughout the identical interval, as a part of our mission to coach stakeholders on our applications and promote illness consciousness, we launched a podcast collection that options conversations with CNS specialists and thought leaders to debate key developments within the neurodegenerative illness house.”
“We kicked off 2023 asserting the completion of enrollment in our Section 2 SEQUEL examine for mild-to-moderate Alzheimer’s illness with topline outcomes anticipated later this 12 months,” Ms. Ricciardi continued. “We additionally acquired clearance from the US FDA to proceed with our 540-patient START examine that may examine the remedy potential of CT1812 in early Alzheimer’s illness and anticipate commencing the trial this 12 months. Lastly, we lately obtained the FDA’s clearance on our IND software to pursue a Section 2 examine of CT1812 in 240 sufferers with geographic atrophy. Our intensive non-dilutive grant funding helps nearly all of our trials. Taken collectively, we imagine we’re ready to effectively execute all of our set goals throughout the enterprise, and we sit up for delivering on our objectives,” concluded Ms. Ricciardi.
- Established an ATM program with Cantor Fitzgerald & Co. and B. Riley Securities and entered right into a dedicated funding settlement with Lincoln Park Capital, topic to the provisions of the relevant agreements, offering entry to capital and continued liquidity for the funding of the Firm.
- Accomplished follow-on public providing receiving gross proceeds of roughly $6 million with none related warrants or different investor incentives.
- Awarded an extra $2.1 million by the NIA for the SEQUEL examine. Whole grants remaining as of December 31, 2022 had been $89.3 million.
Enterprise and Company Highlights:
- Highlights of Section 2 SHIMMER examine of CT1812 in dementia with Lewy our bodies offered at CTAD 2022
- Expanded Section 2 SHINE Research to incorporate websites in Spain, the Netherlands, and Czech Republic; first affected person dosed in Europe in expanded examine
- Cognition Therapeutics and accomplice, ACTC acquired FDA clearance for Section 2 START Research in early Alzheimer’s illness
- Obtained IND clearance from the FDA for a Section 2 trial of CT1812 in sufferers with geographic atrophy secondary to dry AMD
- Accomplished enrollment in SEQUEL Section 2 trial in mild-to-moderate Alzheimer’s illness
- Launch of Cognition Conversations podcast, which goals to advertise neurodegenerative illness consciousness and training
- Upcoming presentation at AD/PD of proteomic knowledge supporting CT1812’s mechanism of motion in sufferers with Alzheimer’s illness
- Presentation of medical biomarker and preclinical knowledge on the 2022 Dry AMD Therapeutic Improvement Summit to help deliberate Section 2 trial
Money and money equivalents: On December 31, 2022, the Firm’s money stability was $41.6 million. The Firm estimates that it has enough money to fund operations and capital expenditures into the second half of 2024.
For the 12 months ended December 31, 2022, analysis and improvement bills had been $30.3 million in comparison with $18.6 million for 2021. The rise within the Firm’s R&D bills for 2022 was primarily attributable to a rise in medical applications associated to elevated Section 2 trial exercise, and a rise in related personnel prices.
For the 12 months ended December 31, 2022, common and administrative bills had been $13.2 million in comparison with $10.0 million for a similar interval in 2021. The rise generally and administrative bills was primarily attributable to elevated prices related to being a public firm.
For the 12 months ended December 31, 2022, Cognition Therapeutics reported a web lack of $21.4 million, or $0.91 per fundamental and diluted share, in comparison with a web lack of $11.7 million, or $3.13 per fundamental and diluted share for 2021.
Convention Name Data
Administration will host a convention name and dwell webcast to debate Cognition’s monetary outcomes immediately at 8:00 a.m. ET. To take part within the convention name, dial (800) 715-9871 (U.S.) or (646) 307-1963 (worldwide) and supply convention ID quantity 8663531. Alternatively, you could hook up with the dwell webcast through the hyperlink on the Investor Relations web page of the Cognition web site at www.cogrx.com.
The archived webcast will likely be accessible for 90 days starting at roughly 9:30 a.m. ET, on Thursday, March 23, 2023.
About Cognition Therapeutics:
Cognition Therapeutics, Inc. is a clinical-stage biopharmaceutical firm engaged within the discovery and improvement of progressive, small molecule therapeutics focusing on age-related degenerative problems of the central nervous system and retina. We’re at present investigating our lead candidate CT1812 in medical applications in Alzheimer’s illness, dementia with Lewy our bodies (DLB) and dry age-related macular degeneration (dry AMD). We imagine CT1812 and our pipeline of σ-2 receptor modulators can regulate pathways which are impaired in these ailments. We imagine that focusing on the σ-2 receptor with CT1812 represents a mechanism functionally distinct from different present approaches in medical improvement for the remedy of degenerative ailments. Extra about Cognition Therapeutics and its pipeline will be discovered at https://cogrx.com/
This press launch incorporates forward-looking statements inside the which means of The Non-public Securities Litigation Reform Act of 1995. All statements contained on this press launch, apart from statements of historic information or statements that relate to current information or present circumstances, are forward-looking statements. These statements, together with statements referring to the timing and anticipated outcomes of our medical trials, and money runway, contain identified and unknown dangers, uncertainties and different necessary components which will trigger our precise outcomes, efficiency, or achievements to be materially completely different from any future outcomes, efficiency, or achievements expressed or implied by the forward-looking statements. In some circumstances, you possibly can establish forward-looking statements by phrases resembling “might,” would possibly,” “will,” “ought to,” “count on,” “plan,” “purpose,” “search,” “anticipate,” “might,” “intend,” “goal,” “mission,” “ponder,” “imagine,” “estimate,” “predict,” “forecast,” “potential” or “proceed” or the unfavourable of those phrases or different related expressions. We’ve got primarily based these forward-looking statements largely on our present expectations and projections about future occasions and monetary traits that we imagine might have an effect on our enterprise, monetary situation, and outcomes of operations. These forward-looking statements converse solely as of the date of this press launch and are topic to a variety of dangers, uncertainties and assumptions, a few of which can’t be predicted or quantified and a few of that are past our management. Components which will trigger precise outcomes to vary materially from present expectations embody, however usually are not restricted to: competitors; our capability to safe new (and retain present) grant funding; our capability to develop and handle progress, keep relationships with suppliers and retain our administration and key staff; our capability to efficiently advance our present and future product candidates via improvement actions, preclinical research and medical trials and prices associated thereto; uncertainties inherent within the outcomes of preliminary knowledge and pre-clinical research being predictive of the outcomes of medical trials; the timing, scope and chance of regulatory filings and approvals, together with regulatory approval of our product candidates; adjustments in relevant legal guidelines or laws; the chance that the we could also be adversely affected by different financial, enterprise or aggressive components, together with ongoing financial uncertainty; our estimates of bills and profitability; the evolution of the markets by which we compete; our capability to implement our strategic initiatives and proceed to innovate our present merchandise; our capability to defend our mental property; the affect of the continuing COVID-19 pandemic on our enterprise, provide chain and labor drive; and the dangers and uncertainties described within the “Danger Components” part of our annual and quarterly studies filed the Securities Change Fee. These dangers usually are not exhaustive and we face each identified and unknown dangers. You shouldn’t depend on these forward-looking statements as predictions of future occasions. The occasions and circumstances mirrored in our forward-looking statements is probably not achieved or happen, and precise outcomes might differ materially from these projected within the forward-looking statements. Furthermore, we function in a dynamic trade and financial system. New threat components and uncertainties might emerge now and again, and it isn’t potential for administration to foretell all threat components and uncertainties that we might face. Besides as required by relevant regulation, we don’t plan to publicly replace or revise any forward-looking statements contained herein, whether or not on account of any new data, future occasions, modified circumstances or in any other case.
Cognition Therapeutics, Inc.
Unaudited Chosen Monetary Knowledge
|For the Yr Ended|
|(in 1000’s, besides share and per share knowledge)||December 31,|
|Consolidated Statements of Operations Knowledge:||2022||2021|
|Analysis and improvement||$||30,324||$||18,572|
|Basic and administrative||13,227||10,026|
|Whole working bills||43,551||28,598|
|Loss from operations||(43,551||)||(28,598||)|
|Different earnings (expense):|
|Change within the truthful worth of the by-product legal responsibility||—||2,209|
|Change within the truthful worth of the Easy Agreements for Future Fairness||—||(2,236||)|
|Different expense, web||(35||)||(88||)|
|Achieve on debt extinguishment||—||443|
|Whole different earnings, web||22,154||16,882|
|Cumulative most popular inventory dividends||—||(4,532||)|
|Web loss attributable to widespread stockholders||$||(21,397||)||$||(16,248||)|
|Unrealized loss on overseas foreign money translation||(1||)||(11||)|
|Whole complete loss||$||(21,398||)||$||(11,727||)|
|Web loss per share:|
|Weighted-average widespread shares excellent:|
|(in 1000’s)||As of December 31,|
|Consolidated Steadiness Sheet Knowledge:||2022||2021|
|Money and money equivalents||$||41,562||$||54,721|
|Whole stockholders’ fairness||40,249||51,273|
Cognition Therapeutics, Inc.
Aline Sherwood (media)
Daniel Kontoh-Boateng (buyers)
Tiberend Strategic Advisors, Inc.