crvo20241104_8k.htm
false 0001053691 0001053691 2024-11-04 2024-11-04
 


 
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
___________________________
 
FORM 8-K
___________________________
 
CURRENT REPORT
Pursuant to Section 13 or 15(d)
of The Securities Exchange Act of 1934
 
November 4, 2024
Date of Report (Date of earliest event reported)
___________________________
 
CervoMed Inc.
(Exact name of registrant as specified in its charter)
___________________________
 
Delaware
 
001-37942
 
30-0645032
(State or other jurisdiction
of incorporation)
 
(Commission
File Number)
 
(I.R.S. Employer
Identification No.)
   
20 Park Plaza, Suite 424
Boston, Massachusetts
 
02116
(Address of principal executive offices)
 
(Zip Code)
 
Registrants telephone number, including area code: (617) 744-4400
 
Not applicable
(Former name or former address, if changed since last report)
___________________________
 
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
 
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
 
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
 
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
 
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
 
Title of each class
 
Trading
Symbol(s)
 
Name of each exchange
on which registered
Common Stock, $0.001 par value
 
CRVO
 
NASDAQ Capital Market
 
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
 
Emerging growth company  
 
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐ 
 


 
 

 
Item 8.01
Other Events
 
On November 4, 2024, CervoMed Inc. issued a press release announcing key takeaways from two oral presentations characterizing the potential of neflamapimod as a treatment for patients with dementia with Lewy bodies that were presented at the Clinical Trials on Alzheimer’s Disease Conference. A copy of the press release is attached hereto as Exhibit 99.1 and is incorporated by reference herein.
 
Item 9.01
Financial Statements and Exhibits
 
(d)         Exhibits
 
Exhibit No.
 
Description
     
99.1
 
104
 
Cover Page Interactive Data File (embedded within the Inline XBRL document).
 
 

 
SIGNATURES
 
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
 
Date: November 4, 2024    
CervoMed Inc.
 
     
 
By:
/s/ William Elder
 
 
Name:
William Elder
 
 
Title:
Chief Financial Officer & General Counsel
 
 
 
ex_742707.htm

Exhibit 99.1

 

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CervoMed Announces Key Takeaways from Oral Presentations at the 17th Clinical Trials on Alzheimer's Disease Conference (CTAD)

 

Data from the AscenD-LB Phase 2a trial in DLB confirm recent scientific literature indicating that plasma glial fibrillary acid protein (GFAP) is a robust measure of neurodegenerative disease activity in DLB

 

Neflamapimod treatment previously led to significant reduction in plasma GFAP levels (p=0.015 versus placebo) and these reductions were associated with an improvement in clinical outcomes

 

The RewinD-LB Phase 2b clinical study successfully enrolled a DLB patient population that is optimized to show the treatment effect of neflamapimod when topline data are reported in December

 

Boston, November 4, 2024 CervoMed Inc. (NASDAQ: CRVO), a clinical-stage company focused on developing treatments for age-related neurologic disorders, today announced key takeaways from two oral presentations characterizing the potential of neflamapimod as a treatment for patients with dementia with Lewy bodies (DLB) that were presented at the Clinical Trials on Alzheimer’s Disease Conference (CTAD) on November 1, 2024.

 

“DLB is a rapidly debilitating condition affecting over 1.4 million patients in the U.S. and EU that has no approved treatment,” said John Alam, MD, Chief Executive Officer of CervoMed. “As we approach the December topline results for our innovative proof-of-concept RewinD-LB Phase 2b clinical trial of neflamapimod, we are excited to share additional results on the effect of neflamapimod treatment on an important biomarker of DLB neurodegenerative disease activity, as well as the baseline characteristics of the patients enrolled into the Phase 2b study. Taken together, we believe the findings further increase the probability of success of the clinical trial”

 

Dr. Alam continued, “For both Alzheimer’s disease and DLB, the utilization of imaging and blood testing to exclude patients with high levels of tau pathology has emerged as a powerful tool to focus clinical trials on patients who have the least amounts of fixed, irreversible neurodegeneration, thereby increasing the magnitude of the clinical effect and probability of success. In the first presentation, through demonstrating significant beneficial effects on a robust blood biomarker of DLB disease activity and correlating that effect to the clinical outcome and underlying pathology, we show that neflamapimod in our Phase 2a clinical study reduced neurodegenerative disease activity in the basal forebrain cholinergic system and its clinical activity is mediated by that effect. In the second presentation we show that the clinical profile of the patients enrolled into RewinD-LB has substantial clinical disease burden and is similar to that in the patients without biomarker evidence of tau pathology group in the Phase 2a study, the group that showed the highest magnitude treatment response. We believe successfully enrolling a DLB patient population that has substantial clinical disease burden, while not have biomarker evidence of tau pathology, and with it a higher expected magnitude treatment effect than if the study had enrolled patients without screening for level of tau pathology, further increases our confidence in the outcome of the RewinD-LB trial.”

 

 

 

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The presentations are accessible on the “Presentations and Publications” section of the CervoMed website.

 

 

Title: Plasma biomarker data indicates clinical activity of neflamapimod in dementia with Lewy bodies (DLB) is mediated through effects on the basal forebrain cholinergic system

 

 

Authors: John Alam, Charlotte Teunissen; CervoMed Inc 

 

 

Title: Participants enrolled in the RewinD-LB clinical trial: a large cohort of patients with dementia with Lewy bodies (DLB) without tau-related temporal lobe neurodegeneration, as defined by absence of elevation in plasma ptau181

 

 

Authors: Stephen Gomperts (Mass General, US), John-Paul Taylor (Newcastle University, UK), Paul Maruff (Cosgate Ltd, UK), Amanda Gardner (Cervomed), Kelly Blackburn (Cervomed), John Alam (Cervomed), James Galvin (Univ of Miami, US)

 

Key takeaways from the presentations: 

 

We have demonstrated a treatment effect on a robust biomarker of neurogenerative disease activity in DLB. Plasma GFAP is highly correlated to cognitive decline as well as to neuronal and neurofibrillary tangles, a pathologic measure of neurodegenerative disease activity. Plasma GFAP is also the first biomarker that is elevated in the evolution of DLB, which combined with the treatment effect of cholinergic directed therapy such as neflamapimod, indicates that elevated plasma GFAP in DLB patients that do not have biomarker evidence of tau pathology reflects neurodegenerative disease activity in the basal forebrain cholinergic system. Accordingly, the treatment effect of neflamapimod on plasma GFAP in DLB patient with low tau pathology in the Phase 2a clinical study demonstrates that neflamapimod reduces neurodegenerative disease activity in the basal forebrain cholinergic system and its clinical activity is mediated by that effect.

 

We are targeting a patient population that is most likely to respond to neflamapimod in the RewinD-LB trial. Compared to Early AD patients, DLB patients without tau pathology are afflicted by higher clinical disease burden, as measured by the Clinical Dementia Rating Sum of Boxes (CDR-SB), due to having disease in the basal forebrain cholinergic system. Combined with the Phase 2a data demonstrating the high level of treatment effect in these patients, DLB patients who do not have biomarker evidence of tau pathology represent an ideal patient population for evaluating a cholinergic-directed therapy such as neflamapimod.

 

By exclusively enrolling patients without biomarker evidence of tau pathology the sample size of RewinD-LB provides high statistical power to detect a statistically significant and clinically meaningful difference between neflamapimod and placebo. The sample size for RewinD-LB of 80 per patients per arm was originally chosen to have sufficient statistical power to detect the expected treatment effect in a population including patients both with and without biomarker evidence of tau pathology. By including only patients without biomarker evidence of tau pathology, while maintaining the original sample size, the study has greater than 95%, approaching 100% statistical power for meeting its primary endpoint, change in CDR-SB in neflamapimod-treated patients compared to placebo.

 

 

 

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About CervoMed

 

CervoMed Inc. (the “Company”) is a clinical-stage company focused on developing treatments for age-related neurologic disorders. The Company is currently developing neflamapimod, an investigational, orally administered small molecule brain penetrant that inhibits p38 mitogen-activated protein kinase alpha. Neflamapimod has the potential to treat synaptic dysfunction, the reversible aspect of the underlying neurodegenerative processes that causes disease in DLB and certain other major neurological disorders. Neflamapimod is currently being evaluated in a Phase 2b study in patients with early-stage DLB.

 

Forward-Looking Statements

 

This press release includes express and implied forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, regarding the intentions, plans, beliefs, expectations or forecasts for the future of the Company, including, but not limited to, the therapeutic potential of neflamapimod and the anticipated timing and achievement of clinical and development milestones, including the completion and achievement of primary endpoints of the RewinD-LB Phase 2b clinical trial and the Company’s announcement of topline and other data therefrom, and any other expected or implied benefits or results, including that any initial clinical results observed with respect to neflamapimod in the AscenD-LB Trial or RewinD-LB Trial will be replicated in later trials. Terms such as “believes,” “estimates,” “anticipates,” “expects,” “plans,” “aims,” “seeks,” “intends,” “may,” “might,” “could,” “might,” “will,” “should,” “approximately,” “potential,” “target,” “project,” “contemplate,” “predict,” “forecast,” “continue,” or other words that convey uncertainty of future events or outcomes (including the negative of these terms) may identify these forward-looking statements. Although there is believed to be reasonable basis for each forward-looking statement contained herein, forward-looking statements by their nature involve risks and uncertainties, known and unknown, many of which are beyond the Company’s control and, as a result, actual results could differ materially from those expressed or implied in any forward-looking statement. Particular risks and uncertainties include, among other things, those related to: the Company’s available cash resources and the availability of additional funds on acceptable terms; the results of the Company’s clinical trials, including RewinD-LB; the likelihood and timing of any regulatory approval of neflamapimod or the nature of any feedback the Company may receive from the U.S. Food and Drug Administration; the ability to implement business plans, forecasts, and other expectations in the future; general economic, political, business, industry, and market conditions, inflationary pressures, and geopolitical conflicts; and the other factors discussed under the heading “Risk Factors” in the Company’s Annual Report on Form 10-K for the year ended December 31, 2023 filed with the U.S. Securities and Exchange Commission (SEC) on March 29, 2024, and other filings that the Company may file from time to time with the SEC. Any forward-looking statements in this press release speak only as of the date hereof (or such earlier date as may be identified). The Company does not undertake any obligation to update such forward-looking statements to reflect events or circumstances after the date of this press release, except to the extent required by law.

 

Investor Contact:

 

PJ Kelleher

 

LifeSci Advisors

 

Investors@cervomed.com

 

617-430-7579