Cognition Therapeutics Reports Financial Results for the Third Quarter 2024 and Provides Business and Clinical Update
Cognition Therapeutics (NASDAQ: CGTX) reported significant results from its Phase 2 SHINE study, showing CT1812 slowed cognitive decline by 95% in Alzheimer's patients with lower p-tau217 levels. The company expects to report topline results from Phase 2 SHIMMER study in DLB patients by end of 2024. Financial results show cash position of $22.0 million as of September 30, 2024, with additional $53.6 million in NIA grant funds. Q3 2024 resulted in a net loss of $9.9 million, or $(0.25) per share, compared to $6.7 million loss in Q3 2023. R&D expenses were $11.4 million, slightly down from $11.7 million in the previous year.
Cognition Therapeutics (NASDAQ: CGTX) ha riportato risultati significativi dal suo studio di Fase 2 SHINE, dimostrando che CT1812 ha rallentato il declino cognitivo del 95% nei pazienti affetti da Alzheimer con livelli più bassi di p-tau217. L'azienda prevede di annunciare i risultati preliminari dello studio di Fase 2 SHIMMER sui pazienti con DLB entro la fine del 2024. I risultati finanziari mostrano una posizione di cassa di $22,0 milioni al 30 settembre 2024, con ulteriori $53,6 milioni in fondi concessi dal NIA. Il terzo trimestre del 2024 ha registrato una perdita netta di $9,9 milioni, ovvero $(0,25) per azione, rispetto a una perdita di $6,7 milioni nel terzo trimestre del 2023. Le spese per R&S sono state di $11,4 milioni, leggermente in calo rispetto agli $11,7 milioni dell'anno precedente.
Cognition Therapeutics (NASDAQ: CGTX) reportó resultados significativos de su estudio de Fase 2 SHINE, mostrando que CT1812 ralentizó el deterioro cognitivo en un 95% en pacientes con Alzheimer con niveles más bajos de p-tau217. La compañía espera reportar resultados preliminares del estudio de Fase 2 SHIMMER en pacientes con DLB para finales de 2024. Los resultados financieros muestran una posición de efectivo de $22.0 millones al 30 de septiembre de 2024, con $53.6 millones adicionales en fondos de subvenciones del NIA. El tercer trimestre de 2024 resultó en una pérdida neta de $9.9 millones, o $(0.25) por acción, comparado con una pérdida de $6.7 millones en el tercer trimestre de 2023. Los gastos de I+D fueron de $11.4 millones, ligeramente por debajo de los $11.7 millones del año anterior.
Cognition Therapeutics (NASDAQ: CGTX)는 2상 SHINE 연구에서 중요한 결과를 발표했으며, CT1812가 p-tau217 수치가 낮은 알츠하이머 환자에서 인지 감소를 95% 만큼 늦췄음을 보여주었습니다. 이 회사는 2024년 말까지 DLB 환자를 대상으로 하는 2상 SHIMMER 연구의 topline 결과를 보고할 예정입니다. 재무 결과에 따르면 2024년 9월 30일 기준 현금 위치는 $22.0 백만이며, NIA 보조금에서 추가로 $53.6 백만이 있습니다. 2024년 3분기 동안의 순손실은 $9.9 백만, 즉 주당 $(0.25)로, 2023년 3분기의 $6.7 백만 손실에 비해 증가했습니다. 연구개발 비용은 $11.4 백만으로, 전년도 $11.7 백만에서 약간 감소했습니다.
Cognition Therapeutics (NASDAQ: CGTX) a rapporté des résultats significatifs de son étude de Phase 2 SHINE, montrant que CT1812 a ralenti le déclin cognitif de 95% chez les patients atteints d'Alzheimer avec des niveaux de p-tau217 plus faibles. L'entreprise s'attend à publier des résultats préliminaires de l'étude de Phase 2 SHIMMER chez les patients atteints de DLB d'ici la fin de 2024. Les résultats financiers montrent une position de trésorerie de $22,0 millions au 30 septembre 2024, avec $53,6 millions supplémentaires en fonds de subvention NIA. Le troisième trimestre de 2024 a entraîné une perte nette de $9,9 millions, soit $(0,25) par action, comparé à une perte de $6,7 millions au troisième trimestre 2023. Les dépenses de R&D ont été de $11,4 millions, légèrement en baisse par rapport à $11,7 millions l'année précédente.
Cognition Therapeutics (NASDAQ: CGTX) hat bedeutende Ergebnisse aus seiner Phase-2-Studie SHINE veröffentlicht, die zeigen, dass CT1812 den kognitiven Rückgang bei Alzheimer-Patienten mit niedrigeren p-tau217-Spiegeln um 95% verlangsamt hat. Das Unternehmen plant, bis Ende 2024 vorläufige Ergebnisse der Phase-2-Studie SHIMMER bei DLB-Patienten zu berichten. Die finanziellen Ergebnisse zeigen eine Liquiditätsposition von $22,0 Millionen zum 30. September 2024, sowie zusätzliche $53,6 Millionen an NIA-Fördermitteln. Im dritten Quartal 2024 betrug der Nettoverlust $9,9 Millionen, also $(0,25) pro Aktie, im Vergleich zu einem Verlust von $6,7 Millionen im dritten Quartal 2023. Die F&E-Ausgaben lagen bei $11,4 Millionen, leicht niedriger als die $11,7 Millionen des Vorjahres.
- CT1812 demonstrated 95% slowing of cognitive decline on ADAS-Cog11 scale in Alzheimer's patients
- Additional 108% slowing of cognitive decline observed on MMSE scale
- $53.6 million in NIA grant funds remaining available
- Sufficient cash runway into Q2 2025
- Net loss increased to $9.9 million in Q3 2024 from $6.7 million in Q3 2023
- Loss per share increased to $(0.25) from $(0.22) year-over-year
Insights
The Phase 2 SHINE study results for CT1812 represent a significant breakthrough in Alzheimer's treatment. The
The company's cash position of
The strategic positioning of CT1812 across multiple neurodegenerative indications (Alzheimer's, DLB and geographic atrophy) demonstrates strong pipeline diversification. The biomarker-driven approach using p-tau217 levels could significantly improve patient selection, potentially leading to better trial outcomes and commercial success. This positions Cognition uniquely in the competitive Alzheimer's landscape.
With a market cap of just
- CT1812 slowed cognitive decline by
- On track to report topline results from Phase 2 SHIMMER study investigating CT1812 in patients with mild-to-moderate dementia with Lewy bodies (DLB) by end of 2024 -
PURCHASE, N.Y., Nov. 13, 2024 (GLOBE NEWSWIRE) -- 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 third quarter ended September 30, 2024, and provided a business update.
“In the third quarter and recent weeks Cognition Therapeutics achieved one of the most important milestones in its history as the Phase 2 SHINE study results became available. Among the many findings in the SHINE study, new and compelling data presented at CTAD showed a near-total preservation of cognition (as measured by the ADAS-Cog11 and MMSE scales) in a sub-group of Alzheimer’s patients treated with CT1812 who had p-tau217 levels below median,” said Lisa Ricciardi, Cognition’s president and CEO. “We are moving rapidly to advance CT1812 in Alzheimer’s disease and plan to request an end-of-Phase 2 meeting with the FDA where we will review CT1812’s safety and tolerability profile as well as the totality of results from SHINE. We will seek alignment with the FDA on a pivotal Phase 3 program design in light of recent findings relating to lower levels of plasma p-tau217, an important biomarker of Alzheimer’s disease pathology easily measured with a blood test.”
Ms. Ricciardi concluded: “In addition to the substantial progress we have made with CT1812 in Alzheimer’s disease, we expect to report top-line results from our Phase 2 SHIMMER study in mild-to-moderate dementia with Lewy bodies (DLB) by the end of this year. DLB is the second most common neurodegenerative disease, yet few therapies have been studied in this indication and no disease-modifying treatments exist. SHIMMER will deliver safety and tolerability data in a second indication and potentially provide insights to be integrated into a larger clinical study in this under-studied and under-represented population.”
Business and Corporate Highlights
- Results of a pre-specified analysis from the Phase 2 SHINE study of CT1812 in participants with mild-to-moderate Alzheimer’s disease were presented in an oral session at the Clinical Trials on Alzheimer’s Disease (CTAD) conference
- Patients with baseline levels of p-tau217 below the median showed a
95% slowing of cognitive decline on the ADAS-Cog11 scale and108% slowing of cognitive decline on the MMSE scale* - Lower levels of plasma p‑tau217 are indicative of less advanced Alzheimer’s pathology, and we believe may identify patients likely to have a greater response to therapy
- The CTAD presentation by Dr. Michael Woodward and an archive of investor webinar are available on the Cognition website
- Patients with baseline levels of p-tau217 below the median showed a
- Baseline characteristics of participants enrolled in the Phase 2 SHIMMER study were also presented at CTAD, confirming enrollment of individuals with mild-to-moderate DLB
- This poster is available on the Company’s website
- Continued enrollment in Phase 2 START study (NCT05531656) in early Alzheimer’s disease and Phase 2 MAGNIFY study (NCT05893537) in geographic atrophy secondary to dry age-related macular degeneration
Third Quarter 2024 Financial Results
Cash and cash equivalents as of September 30, 2024 were approximately
Research and development expenses were
General and administrative expenses were
The Company reported a net loss of
* ADAS-Cog11: Alzheimer’s Disease Assessment Scale – Cognitive Subscale (11-task version); MMSE: Mini Mental State Examination
About Cognition Therapeutics, Inc.
Cognition Therapeutics, Inc., is a clinical-stage biopharmaceutical company discovering and developing innovative, small molecule therapeutics targeting age-related degenerative disorders of the central nervous system and retina. We currently are 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 σ-2 receptor modulators can regulate pathways that are impaired in these diseases that are functionally distinct from other approaches for the treatment of degenerative diseases. More about Cognition Therapeutics and our 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, including but not limited to, statements regarding 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 later trials and our clinical development plans, are forward-looking statements. These statements, including statements relating to the timing and expected results of our clinical trials and our regulatory plans 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, pre-clinical studies and earlier-stage clinical trials being predictive of the results of early or later-stage 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; impacts of ongoing global and regional conflicts on our business, supply chain and labor force; our ability to maintain the listing of our common stock on the Nasdaq Global Market and the risks and uncertainties described more fully in the “Risk Factors” section of our annual and quarterly reports filed with the Securities & Exchange Commission and are available at www.sec.gov. 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. Unaudited Selected Financial Data | |||||||||||||||||
| (in thousands, except share and per share data amounts) | Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||
| Consolidated Statements of Operations Data: | 2024 | 2023 | 2024 | 2023 | |||||||||||||
| Operating Expenses: | |||||||||||||||||
| Research and development | $ | 11,392 | $ | 11,669 | $ | 33,522 | $ | 25,596 | |||||||||
| General and administrative | 3,071 | 3,076 | 9,721 | 9,939 | |||||||||||||
| Total operating expenses | 14,463 | 14,745 | 43,243 | 35,535 | |||||||||||||
| Loss from operations | (14,463 | ) | (14,745 | ) | (43,243 | ) | (35,535 | ) | |||||||||
| Other income (expense): | |||||||||||||||||
| Grant income | 4,293 | 7,684 | 16,516 | 18,035 | |||||||||||||
| Other income (expense), net | 236 | 314 | 813 | (129 | ) | ||||||||||||
| Interest expense | (3 | ) | (2 | ) | (20 | ) | (18 | ) | |||||||||
| Loss on currency translation from liquidation of subsidiary | — | — | (195 | ) | — | ||||||||||||
| Total other income, net | 4,526 | 7,996 | 17,114 | 17,888 | |||||||||||||
| Net loss | $ | (9,937 | ) | $ | (6,749 | ) | $ | (26,129 | ) | $ | (17,647 | ) | |||||
| Foreign currency translation adjustment, including reclassifications | — | — | 195 | 3 | |||||||||||||
| Total comprehensive loss | $ | (9,937 | ) | $ | (6,749 | ) | $ | (25,934 | ) | $ | (17,644 | ) | |||||
| Net loss per share: | |||||||||||||||||
| Basic | $ | (0.25 | ) | $ | (0.22 | ) | $ | (0.69 | ) | $ | (0.59 | ) | |||||
| Diluted | $ | (0.25 | ) | $ | (0.22 | ) | $ | (0.69 | ) | $ | (0.59 | ) | |||||
| Weighted-average common shares outstanding: | |||||||||||||||||
| Basic | 40,418,065 | 30,265,506 | 38,080,658 | 29,696,296 | |||||||||||||
| Diluted | 40,418,065 | 30,265,506 | 38,080,658 | 29,696,296 | |||||||||||||
| As of | |||||||||||||||||
| (in thousands) | September 30, 2024 | December 31, 2023 | |||||||||||||||
| Consolidated Balance Sheet Data: | |||||||||||||||||
| Cash and cash equivalents | $ | 22,011 | $ | 29,922 | |||||||||||||
| Total assets | 27,579 | 35,163 | |||||||||||||||
| Total liabilities | 13,097 | 10,689 | |||||||||||||||
| Accumulated deficit | (167,318 | ) | (141,189 | ) | |||||||||||||
| Total stockholders’ equity | 14,482 | 24,474 | |||||||||||||||
| Contact Information: Cognition Therapeutics, Inc. info@cogrx.com | Casey McDonald (media) Tiberend Strategic Advisors, Inc. cmcdonald@tiberend.com | Mike Moyer (investors) LifeSci Advisors mmoyer@lifesciadvisors.com |
This press release was published by a CLEAR® Verified individual.
FAQ
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