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業績公告 即時報告 8-K 2026-08-06

Cognition Therapeutics公佈Q2業績 現金可續航至2027年底 擬2027年中啟動DLB三期試驗

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Cognition Therapeutics(NASDAQ: CGTX)公佈2026年第二季度財務業績及業務更新。作為一家專注神經退化性疾病療法研發的臨床階段生物製藥公司,期內重點在於與美國FDA就「路易體失智症伴精神病」(DLB psychosis)的註冊性三期臨床試驗設計進行了會議溝通,並獲得關鍵明確指引。公司計劃於2027年中啟動該三期研究,並採用改良後的片劑配方。此外,公司接獲一項新專利的核准通知,涵蓋藥物zervimesine(CT1812)的多晶型結晶組成、生產程序及治療阿茲海默症與路易體失智症的方法;專利一旦正式發出,保護期可延長至2045年(未計專利期限延長)。公司亦延長了zervimesine在路易體失智症的擴大使用計劃(EAP)至2027年,並獲得第二位慈善捐贈者資助;同時在阿茲海默症協會國際會議(AAIC)上發表了擬議三期研究設計的海報。 財務數據方面,截至2026年6月30日,公司現金及等價物(含受限制現金)約為3,480萬美元,另有來自美國國家老化研究所(NIA/NIH)的未動用撥款約2,160萬美元。公司估計現有資金足以支持營運及資本開支至2027年第四季度。 季度業績:研究開發費用為510萬美元,較2025年同期的1,150萬美元大幅下降,主要由於合約研究機構相關試驗活動、薪酬及專業費用減少;一般及行政費用為260萬美元,略高於2025年同期的250萬美元,主因專業服務費增加。期內淨虧損為390萬美元,每股虧損0.04美元,對比2025年第二季度淨虧損670萬美元、每股虧損0.11美元,虧損顯著收窄。上半年累計淨虧損為850萬美元(每股0.09美元),2025年同期為1,520萬美元(每股0.24美元)。 管理層表示,第二季度在臨床及企業優先事項上均取得進展,FDA會議為三期試驗關鍵設計提供清晰方向,新專利亦強化了管線長期價值。對投資者而言,重點在於三期試驗啟動時間表、專利保護延長至2045年,以及資金可續航至2027年底;惟需留意臨床開發固有的監管及試驗風險。📉🧪
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EX-99.1
2
tm2622462d1_ex99-1.htm
EXHIBIT 99.1

 

 

Exhibit 99.1

 

 

 

Cognition Therapeutics Reports Financial Results
for the Second Quarter 2026 and Provides Business Update

 

Purchase, NY – August 6, 2026 – 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, 2026, and provided a business update.

 

“The second quarter marked important progress across both our
clinical and corporate priorities,” said Lisa Ricciardi, Cognition’s president and CEO. “Discussions with the Food and
Drug Administration (FDA) brought clarity on key aspects of our planned Phase 3 trial for people with dementia with Lewy bodies (DLB)
who experience psychosis (DLB psychosis). We are focused on initiating our Phase 3 study in mid-2027 with an improved tablet composition.
In addition, the allowance of a new composition of matter patent meaningfully extends our intellectual property coverage for zervimesine
and reinforces the long-term value of our pipeline.”

 

Business and Corporate Highlights

·Conducted a planned meeting with the FDA to discuss the design of a registrational
study in DLB psychosis; Company to provide update on timing after alignment on endpoints 

·Received
 a Notice of Allowance for a patent application covering composition of matter, production
 process, and therapeutic method of treating Alzheimer’s disease and DLB with a polymorphic
 crystalline form of zervimesine. Once issued, the patent would extend protection through
 2045 before patent-term extension

·Extended the ongoing expanded access program for zervimesine in DLB through
2027 with funding from a second philanthropic donor

·Presented
 a poster at the Alzheimer’s Association International Convention (AAIC) outlining
 a proposed Phase 3 study design for zervimesine in DLB psychosis.

 

Second Quarter 2026 Financial Results

Cash, cash equivalents, and restricted cash equivalents as of June
30, 2026 were approximately $34.8 million, and total obligated grant funds remaining from the National Institute of Aging, a division
of the National Institute of Health were $21.6 million. The Company estimates that it has sufficient cash to fund operations and capital
expenditures into the fourth quarter of 2027.

 

Research and development expenses were $5.1 million for the quarter
ended June 30, 2026, compared to $11.5 million for the comparable period in 2025. The decrease in research and development expenses was
driven by lower trial activities with contract research organizations, compensation and professional fees.

 

General and administrative expenses were $2.6 million for the quarter
ended June 30, 2026, compared to $2.5 million for the comparable period in 2025. The increase in general and administrative expenses was
driven primarily by higher professional fees.

 

The Company reported a net loss of $3.9 million, or $(0.04) per basic
and diluted share for the second quarter ended June 30, 2026, compared to a net loss of $6.7 million, or $(0.11) per basic and diluted
share for the same period in 2025.

 

 

Cognition Therapeutics, Inc.

www.cogrx.com

 

  

  

 

 

About Cognition Therapeutics 

Cognition Therapeutics, Inc. is a clinical-stage biopharmaceutical
company dedicated to helping millions of families seeking effective treatments for devastating neurodegenerative diseases through the
development of novel, accessible therapies. The company has led pioneering research into the underlying mechanisms of degenerative nerve
disorders. Our scientific approach builds on well-established biological pathways and translates across indications in which toxic oligomers
drive disease progression, offering potential in dementia with Lewy bodies (DLB), Alzheimer’s disease, geographic atrophy, Parkinson’s,
among others. The company’s lead candidate, zervimesine (CT1812), is an investigational once-daily oral therapy that has demonstrated
promise in Phase 2 clinical trials in DLB and mild-to-moderate Alzheimer’s disease. Backed by nearly $200 million in National Institutes
of Health and related foundation grants, Cognition Therapeutics continues to advance clinical research in its efforts to bring forth
solutions that meet patients where they are and reduce caregiver burden. Learn more at cogrx.com.

 

About Zervimesine (CT1812) 

Zervimesine (CT1812) is currently
being studied in the Phase 2 START Study (NCT05531656) in patients with MCI and early Alzheimer’s
disease. Phase 2 clinical studies have been completed in dementia with Lewy bodies (DLB), mild-to-moderate Alzheimer’s disease,
and geographic atrophy secondary to dry AMD. Based in part on the strong efficacy signals observed in the Phase 2 SHIMMER study in DLB
(NCT05225415), the company plans to advance zervimesine into a late-stage clinical trial
for people with DLB psychosis. Zervimesine has been generally well tolerated in clinical studies to date. 

 

The USAN Council has adopted zervimesine as the United States Adopted
Name (USAN) for CT1812.

 

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 or made during the conference,
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 zervimesine (CT1812), and any expected or implied benefits or results, including
that initial clinical results observed with respect to zervimesine will be replicated in later trials and our clinical development plans,
including statements regarding our planned FDA interactions and registrational program for zervimesine, the EAP, and any analyses of the
results therefrom, are forward-looking statements. These statements, including statements relating to the timing and expected results
of our clinical trials 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; the 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.

www.cogrx.com

 

  

  

 

 

Cognition Therapeutics, Inc.

Unaudited Selected Financial Data

 
 
 (in thousands, except share and per share data amounts) 
 Three Months Ended June 30,  
 Six Months Ended June 30, 

 
 Statements of Operations Data: 
 2026  
 2025  
 2026  
 2025 

 
 Operating Expenses: 
     
     
     
    

 
 Research and development 
 $5,097  
 $11,481  
 $11,217  
 $22,267 

 
 General and administrative 
  2,641  
  2,497  
  5,338  
  5,486 

 
 Total operating expenses 
  7,738  
  13,978  
  16,555  
  27,753 

 
 Loss from operations 
  (7,738) 
  (13,978) 
  (16,555) 
  (27,753)

 
 Other income (expense): 
     
     
     
    

 
 Grant income 
  3,518  
  7,106  
  7,497  
  12,192 

 
 Other income, net 
  291  
  141  
  564  
  355 

 
 Interest expense 
  (3) 
  (3) 
  (8) 
  (8)

 
 Total other income, net 
  3,806  
  7,244  
  8,053  
  12,539 

 
 Net loss and comprehensive loss 
 $(3,932) 
 $(6,734) 
 $(8,502) 
 $(15,214)

 
   
     
     
     
    

 
 Net loss per share: 
     
     
     
    

 
 Basic 
 $(0.04) 
 $(0.11) 
 $(0.09) 
 $(0.24)

 
 Diluted 
 $(0.04) 
 $(0.11) 
 $(0.09) 
 $(0.24)

 
 Weighted-average common shares outstanding: 
     
     
     
    

 
 Basic 
  90,624,381  
  63,690,945  
  89,911,806  
  62,169,748 

 
 Diluted 
  90,624,381  
  63,690,945  
  89,911,806  
  62,169,748 

 

 
   
 As of 

 
 (in thousands) 
 June 30, 2026  
 December 31, 2025 

 
 Balance Sheet Data: 
     
    

 
 Cash, cash equivalents, and restricted cash equivalents 
 $34,762  
 $37,000 

 
 Total assets 
  38,896  
  48,390 

 
 Total liabilities 
  5,872  
  14,119 

 
 Accumulated deficit 
  (207,149) 
  (198,647)

 
 Total stockholders’ equity 
  33,024  
  34,271 

 

 
 Contact Information: Cognition Therapeutics, Inc. [email protected]
 Mike Moyer (investors) LifeSci Advisors [email protected]

 

 

 

Cognition Therapeutics, Inc.

www.cogrx.com