View:
Download DOC
Download PDF
Download XLS
Download XBRL
crvo20241030_8k.htm
false 0001053691 0001053691 2024-10-29 2024-10-29
 
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
 
October 29, 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)
 
Registrant’s 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 7.01         Regulation FD Disclosure
 
Corporate Presentation
 
Certain information concerning the business, clinical studies, development plans, financial position and related matters of CervoMed Inc. (the “Company,” “we” or “us”) has been made available on our website, www.cervomed.com, under the heading, “Investors – Events and Presentations.” Representatives of the Company may use this presentation, in whole or in part, and possibly with non-material modifications, periodically in connection with conferences, meetings, and presentations to investors, analysts and others.
 
The information contained in the presentation is summary information that is intended to be considered in the context of the Company’s filings with the U.S. Securities and Exchange Commission (“SEC”) and other public announcements that we may make, by press release or otherwise, from time to time. The Company undertakes no duty or obligation to publicly update or revise the information contained in the presentation except as required by applicable law, although the Company may do so from time to time as its management believes is warranted. Any such updating may be made through the filing of other reports or documents with the SEC, through press releases, or through other public disclosure.
 
The Company makes no admission or representation as to the materiality of any information in the presentation or otherwise contained in Item 7.01 of this Current Report on Form 8-K. The information in this Item 7.01 (including any information incorporated herein by reference) is furnished pursuant to Item 7.01 of Form 8-K and shall not be deemed to be “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of Section 18 of the Exchange Act unless we specifically incorporate it by reference in a document filed under the Exchange Act, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, except as set forth by specific reference in such a filing.
 
Item 8.01         Other Events
 
Press Release
 
On October 29, 2024, the Company issued a press release announcing that it will deliver an oral presentation providing detailed safety and efficacy results from its RewinD-LB Phase 2b clinical trial of neflamapimod in dementia with Lewy bodies at the eighth International Lewy Body Dementia Conference taking place on January 29-31, 2025, in Amsterdam, the Netherlands. 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: October 30, 2024         
CervoMed Inc.
By:
/s/ William Elder
Name:
William Elder
Title:
Chief Financial Officer & General Counsel
 
 
ex_739959.htm

Exhibit 99.1

 https://cdn.kscope.io/8f2db09768bdfd64bc1c4b4b2a4696cf-logo.jpg

CervoMed to Deliver Oral Presentation at the 8th International Lewy Body Dementia Conference

 

Topline data from the RewinD-LB Phase 2b study on track for December 2024

 

Detailed safety and efficacy data from RewinD-LB Phase 2b study to be featured in an oral presentation at the ILBDC conference in January 2025

 

Boston, October 29, 2024 – CervoMed Inc. (NASDAQ: CRVO), a clinical-stage company focused on developing treatments for age-related neurologic disorders, today announced that it will deliver an oral presentation providing detailed safety and efficacy results from its completed RewinD-LB Phase 2b clinical trial of neflamapimod in dementia with Lewy bodies (DLB) at the eighth International Lewy Body Dementia Conference (ILBDC) taking place on January 29-31, 2025 in Amsterdam, the Netherlands.

 

“As we await topline results from the RewinD-LB Phase 2b trial in DLB, we are extremely encouraged by the scientific community’s interest in the data and pleased to have an opportunity to present them at the leading scientific conference dedicated to Lewy Body Dementia,” said John Alam, MD, Chief Executive Officer of CervoMed. “There are currently no approved therapies for DLB, and the dementia clinical research community has a strong interest in the ongoing RewinD-LB Phase 2b study and its potential beneficial impact to patients and families. Topline results for RewinD-LB are expected to be disclosed in December 2024 and we are also presenting data on RewinD-LB baseline patient characteristics at the upcoming Clinical Trials on Alzheimer's Disease Conference (CTAD). Based on our preliminary analyses, we are confident that we have optimized RewinD-LB trial design to detect a statistically significant and clinically meaningful difference between neflamapimod and placebo.”

 

Details of the ILBDC presentation are as follow:

 

Abstract Title: Efficacy and safety results of the RewinD-LB phase 2b clinical trial of neflamapimod in dementia with Lewy bodies (DLB)
Format: Oral Presentation
Session Name: Therapeutics in DLB
Session Date and Time: Friday, January 31, 2025, 14.00-15.30 pm Local Time

 

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.

 

 
 
https://cdn.kscope.io/8f2db09768bdfd64bc1c4b4b2a4696cf-logo.jpg

 

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. 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