Form 8-K - Current report

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 24, 2023

Date of Report (Date of earliest event reported)

___________________________

CervoMed Inc.

(Exact name of registrant as specified in its charter)

___________________________

Delaware	001-24477	30-0645032
(State or other jurisdiction of incorporation)	(Commission File Number)	(I.R.S. Employer Identification No.)

20 Park Plaza, Suite 424 Boston, Massachusetts		02216
(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.

Peer-Reviewed Journal Publications

On October 24, 2023, CervoMed Inc. (the “Company”) issued a press release announcing the publication of two articles that support advancing neflamapimod as a potential disease-modifying treatment for Dementia with Lewy Bodies (“DLB”) and Alzheimer’s Disease, including (i) the final publication in Neurology® of an article previously announced by the Company on September 6, 2023 and (ii) a Research Highlight Article in Molecular Neurodegeneration. The press release is attached hereto as Exhibit 99.1.

CTAD Presentation

On October 25, 2023, the Company issued a press release announcing a presentation highlighting learnings from its Phase 2a clinical trial of neflamapimod in DLB at the 16^th annual Clinical Trial in Alzheimer’s Disease (“CTAD”) conference, held October 24-27, 2023, in Boston, Massachusetts. A copy of the press release is attached hereto as Exhibit 99.2 and a copy of the presentation presented at the CTAD conference is attached hereto as Exhibit 99.3.

Corporate Presentation

Certain information concerning the business, clinical studies, development plans, financial position and related matters of the Company has been made available on our website, www.cervomed.com, under the heading, “Investors – Events and Presentations” and a copy of which is attached as Exhibit 99.4 hereto. 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 Securities and Exchange Commission (“SEC”) and other public announcements that it 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 presentations, in the press releases, or otherwise contained in this Current Report on Form 8-K. The information in this Current Report on Form 8-K and the exhibits thereto are 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 the Company specifically incorporates such information by reference in a document filed under the Exchange Act, nor shall such information be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, except as previously set forth by specific reference in such a filing.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits

The following exhibits relating to Item 7.01 are furnished and not filed:

Exhibit No.		Description

99.1		Press Release, issued October 24, 2023.
99.2		Press Release, issued October 25, 2023.
99.3		Presentation, dated October 25, 2023.
99.4		Corporate Presentation of CervoMed Inc. dated October 25, 2023.
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 25, 2023	CervoMed Inc.


	By:	/s/ John J. Alam
	Name:	John J. Alam
	Title:	Chief Executive Officer

Exhibit 99.1

CervoMed Announces Publications in Major Peer-Reviewed Journals That Inform on Potential of Neflamapimod as a Disease-Modifying Therapy for the Major Dementias

Final publication in Neurology® of Phase 2a Results Stratified by Plasma Phosphorylated Tau Status at Baseline Strengthens the Case for Progressing Neflamapimod as a Disease-Modifying Treatment for Dementia with Lewy Bodies

Research Highlight Article in Molecular Neurodegeneration Comments That Through Acting on Cholinergic Degeneration Neflamapimod Has Potential to have Disease-modifying Effects in Both Dementia with Lewy Bodies and Alzheimer’s Disease

BOSTON, MA – Oct. 24, 2023 – /PRNewsire/ -- CervoMed Inc. (NASDAQ: CRVO), a clinical stage company focused on developing treatments for degenerative diseases of the brain, today announced the publication of the following two articles that support advancing neflamapimod as a disease-modifying treatment for Dementia with Lewy Bodies (DLB) and Alzheimer’s Disease (AD):

●

Alam JJ, Maruff P, Doctrow S, Chu H-M, Conway J, Gomperts SN, Teunissen C.Association of plasma phosphorylated tau with the response to neflamapimod treatment in patients with dementia with Lewy bodies. Neurology, 2023, Volume 101, pages 1-10. The journal has released the final publication, including a Short Version in print, of the article that was the subject of a press release from CervoMed dated September 6^th, 2023. The major finding is that the magnitude of the neflamapimod treatment effect in the DLB phase 2a study in the sub-group with normal plasma ptau181 at study entry (i.e., those with pure DLB, without biomarker evidence of AD related co-pathology) was greater than that seen in the overall study population and substantial, with a treatment effect size relative to placebo of at least 0.7 (indicative of a large effect) for each of the measures of dementia severity, attention, recognition memory, and functional mobility.

●

Alam J and Nixon RA, Drug development targeting degeneration of the basal forebrain cholinergic system: its time has come. Molecular Neurodegeneration (2023) 18:74. This Research Highlight article reviews the preclinical and clinical data in the Neurology® publication and a prior publication in Nature Communications and concludes that the findings are “a major translational step forward” towards treating basal forebrain cholinergic degeneration, the primary pathology in DLB and considered to be a contributor to disease expression and/or progression in multiple other CNS disorders, including AD.

“As reported in Nature Communications last year, the primary analysis of the phase 2a study of DLB showed neflamapimod significantly improved dementia severity and motor function. As now published in the major clinical neurology journal, Neurology, there is consistency and greater magnitude of the clinical effect seen in patients without AD co-pathology, which further strengthens the conclusions regarding the clinical effect in DLB demonstrated in phase 2a,” said John Alam, MD, Chief Executive Officer of CervoMed and first author of both publications announced today. He added, “The Molecular Neurodegeneration article provides a combined evaluation of the findings in the Neurology and Nature Communications articles that makes the case for advancing neflamapimod as a treatment for DLB. Further, the Molecular Neurodegeneration article also comments that the results viewed in the context of the broader scientific literature indicates that neflamapimod also has potential to impact disease progression in Alzheimer’s disease, either as a standalone therapy or in combination with amyloid beta directed therapies.”

About CervoMed

CervoMed Inc. is a clinical-stage biotechnology company advancing CNS-focused therapeutics to benefit patients with a range of degenerative diseases of the brain. The Company is currently developing neflamapimod, an investigational orally administered small molecule brain penetrant that inhibits p38MAP kinase alpha (p38a). Neflamapimod has the potential to treat synaptic dysfunction, the reversible aspect of the underlying neurodegenerative processes that cause disease in dementia with Lewy bodies (DLB) and certain other major neurological disorders. Neflamapimod is currently being evaluated in a Phase 2b study in patients with DLB (RewinD-LB Study). CervoMed was formed in August 2023 with completion of the merger of EIP Pharma Inc. with Diffusion Pharmaceuticals Inc.

For more information, please visit https://www.cervomed.com/ or engage with us on Twitter and LinkedIn.

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 CervoMed Inc. (the “Company”), including, but not limited to, the therapeutic potential of neflamapimod and anticipated timing of clinical milestones. Terms such as “believes,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” “approximately,” “potential” or other words that convey uncertainty of future events or outcomes 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 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 Exhibit 99.2 to the Company's Current Report on Form 8-K/A filed with the U.S. Securities and Exchange Commission (SEC) on September 29, 2023, 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.

Additional Reference:

Jiang, Y, Alam, JJ, Gomperts SN et al., “Preclinical and Randomized Clinical Evaluation of the p38α Kinase Inhibitor Neflamapimod for Basal Forebrain Cholinergic Degeneration,” Nature Communications, 13, Article number: 5308 (2022). https://www.nature.com/articles/s41467-022-32944-3

Contacts

Investors & Media:

Argot Partners

212.600.1902

cervomed@argotpartners.com

Exhibit 99.2

CervoMed Announces Oral Presentation at CTAD 2023 Highlighting Learnings from Phase 2a Which Optimized the Design of the Phase 2b Clinical Study of Neflamapimod in Dementia with Lewy Bodies

With incorporation of key learnings, Phase 2b has >95% (approaching 100%) statistical power

to meet its primary endpoint: change in Clinical Dementia Rating Sum-of-Boxes (CDR-SB) vs. placebo

New data included in the presentation show that in patients without Alzheimer’s-related co-pathology, neflamapimod treatment demonstrates significant reduction vs. placebo of a potential blood biomarker of dementia with Lewy bodies

BOSTON – October 25, 2023 – CervoMed Inc. (NASDAQ: CRVO), a clinical-stage company focused on developing treatments for degenerative diseases of the brain, announced an oral presentation today by Dr. Niels Prins, Chief Executive Officer of the Brain Research Center in the Netherlands, at the 16^thClinical Trials in Alzheimer's Disease (CTAD) conference highlighted the neflamapimod clinical development program, including the RewinD-LB Phase 2b study design and the supportive Phase 2a clinical data, for the treatment of patients with dementia with Lewy bodies (DLB).

“We are pleased to have had the opportunity at this year’s CTAD conference to comprehensively present the findings in Phase 2a and discuss the analyses that went into optimizing the Phase 2b study design for the treatment of patients with DLB,” said John Alam, MD, Chief Executive Officer of CervoMed. “Our Phase 2b DLB study, with its optimized design, has substantial statistical power to detect an effect on the Clinical Dementia Rating Sum-of-boxes, and is currently actively enrolling patients in the US, the UK, and the Netherlands. We look forward to completing enrollment during the first half of 2024 and then reporting initial results from the placebo-controlled portion of the study during the second half of 2024.”

Based on the learnings, the distinctions from Phase 2a in the RewinD-LB study include, (1) the use of one dosing regimen of neflamapimod (40mg capsules three-times-a-day, TID), based on the dose-response analysis of the study, and on observations in AD studies; (2) the choice of Clinical Dementia Rating Sum of Boxes (CDR-SB) as the primary endpoint; and (3) the exclusion of patients with Alzheimer’s related co-pathology, as evaluated by plasma levels of tau phosphorylated at position 181 (ptau181; to enrich for such patients, the global CDR score at entry will be limited to 0.5 or 1.0). With these modifications to the design from Phase 2a, sample size calculations (see below) indicate that the RewinD-LB Phase 2b study has greater than 95% statistical power (approaching 100%) to meet its primary objective of demonstrating improvement relative to placebo on change in CDR-SB over the course of the study.

Highlights of the presentation include the following:

●

The Phase 2a inclusion criteria for the diagnosis of DLB was able to identify and support enrollment of a robust DLB patient population with significant attentional deficits, with >1.5 Standard Deviation (SD) deficits vs. age-adjusted norm in the cognitive tests of attention and/or working memory at baseline. Patients enrolled in the study had lesser decline in executive function, with ≤1 SD deficit in cognitive tests designed to evaluate executive function; consistent with the literature for mild DLB.

●

Clinical endpoints that can detect effects on both cognitive and motor function (specifically, CDR-SB and the Timed Up and Go test, TUG) performed better in the Phase 2a study with respect to detecting improvement over placebo than endpoints that are purely focused on evaluating cognition. The underperformance in Phase 2a of a six cognitive test Neuropsychological Test Battery (NTB) evaluating attention and executive function can be attributed to ceiling effects due to (1) the modest deficits in executive function at baseline and (2) patients in Phase 2a all receiving cholinesterase inhibitors.

●

Sample size for the potential endpoints in Phase 2b were evaluated through clinical trial simulations that utilized individual patient data in Phase 2a for the placebo and neflamapimod 40mg TID recipients. Based on the simulation of 100 clinical trials with 80 patients per treatment group, and assuming a 10% dropout rate, there is ~85% power with the NTB, 95% power with the TUG, and >95% power with CDR-SB (approaching 100%) to detect a treatment effect at an alpha level of 0.05.

●

Electroencephalography (EEG) evaluations in Phase 2a showed that while there were no differences between neflamapimod and placebo in spectral analysis, neflamapimod treatment led to a significant dose-dependent increase vs. placebo in the beta band seen in functional connectivity analysis. These results were previously presented at the International Conference on Alzheimer’s and Parkinson’s Diseases 2022 meeting in Barcelona, Spain (video of presentation available here).

●

In the Phase 2a study, in patients without Alzheimer’s related co-pathology (assessed by plasma ptau181) at study entry, neflamapimod treatment led to significant improvement compared to placebo in the change in plasma levels of glial fibrillary acidic protein (GFAP): from baseline to week-16, GFAP was decreased by mean 10.6 pg/mL in neflamapimod-recipients and increased by mean 14.1 pg/mL in placebo-recipients (p=0.04 for neflamapimod vs. placebo). These data have not been previously presented and a full presentation of the GFAP data is planned for a future scientific conference. Plasma GFAP was recently reported as a potential biomarker for DLB (Hamilton et al, Psychological Medicine, 2023).

A copy of the CTAD presentation is available on the Presentations and Publications section of CervoMed’s website.

About the Phase 2b Study in Dementia with Lewy Bodies (RewinD-LB)

The Phase 2b study, named RewinD-LB, is a randomized, 16-week double-blind, placebo-controlled clinical trial evaluating oral neflamapimod (40mg three times per day) in up to 160 patients with prodromal dementia with Lewy bodies (DLB) or mild dementia due to DLB. Patients completing the 16-week placebo-controlled study period will be able to continue in the study while receiving open label neflamapimod treatment for an additional 32 weeks. Clinical sites are located in the US, the UK, and the Netherlands. Patients with Alzheimer's disease-related co-pathology, assessed by a blood biomarker (plasma ptau181), will be excluded. CervoMed expects to complete enrollment in RewinD-LB during the first half of 2024 and then report initial results from the placebo-controlled portion of the study during the second half of 2024. The RewinD-LB study is funded by a $21 million grant from the National Institutes of Health's National Institute on Aging (NIA), which will be disbursed over the course of the study as costs are incurred. More information, including information on active clinical trial sites, on the RewinD-LB study is available at clinicaltrials.gov.

About CervoMed

CervoMed Inc. is a clinical-stage biotechnology company advancing CNS-focused therapeutics to benefit patients with a range of degenerative diseases of the brain. The Company is currently developing neflamapimod, an investigational orally administered small molecule brain penetrant that inhibits p38MAP kinase alpha (p38a). Neflamapimod has the potential to treat synaptic dysfunction, the reversible aspect of the underlying neurodegenerative processes that cause disease in dementia with Lewy bodies (DLB) and certain other major neurological disorders. Neflamapimod is currently being evaluated in a Phase 2b study in patients with DLB. CervoMed was formed in August 2023 with completion of the merger of EIP Pharma Inc. with Diffusion Pharmaceuticals Inc.

For more information, please visit www.cervomed.com or engage with us on Twitter and LinkedIn.

Forward-Looking Statements

Contacts

Investors & Media:

Argot Partners

212.600.1902

cervomed@argotpartners.com

Exhibit 99.3

Exhibit 99.4

Document And Entity Information	Oct. 24, 2023
Document Information [Line Items]
Entity, Registrant Name	CervoMed Inc.
Document, Type	8-K
Document, Period End Date	Oct. 24, 2023
Entity, Incorporation, State or Country Code	DE
Entity, File Number	001-24477
Entity, Tax Identification Number	30-0645032
Entity, Address, Address Line One	20 Park Plaza, Suite 424
Entity, Address, City or Town	Boston
Entity, Address, State or Province	MA
Entity, Address, Postal Zip Code	02216
City Area Code	617
Local Phone Number	744-4400
Written Communications	false
Soliciting Material	false
Pre-commencement Tender Offer	false
Pre-commencement Issuer Tender Offer	false
Title of 12(b) Security	Common Stock
Trading Symbol	CRVO
Security Exchange Name	NASDAQ
Entity, Emerging Growth Company	false
Amendment Flag	false
Entity, Central Index Key	0001053691