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CervoMed Inc

For the period ended Mar 31, 2024. Filed May 14, 2024.

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About this filing

A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.

Mar 31, 2024 · Filed May 14, 2024

CRVO$1.43+0.7%Stored close · as of Nov 9, 2026

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Table of Contents

CervoMed Inc.

Page No.
Part IPART I – FINANCIAL INFORMATION1
Item 1:ITEM 1. FINANCIAL STATEMENTS1
Item 2:ITEM 2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS18
Item 3:ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK26
Item 4:ITEM 4. CONTROLS AND PROCEDURES26
Part IIPART II – OTHER INFORMATION27
Item 1:ITEM 1. LEGAL PROCEEDINGS27
Item 1A:ITEM 1A. RISK FACTORS27
Item 2:ITEM 2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS27
Item 3:ITEM 3. DEFAULTS UPON SENIOR SECURITIES27
Item 4:ITEM 4. MINE SAFETY DISCLOSURES27
Item 5:ITEM 5. OTHER INFORMATION27
Item 6:ITEM 6. EXHIBITS28
Signatures29

i

INTRODUCTORY NOTES

Note Regarding Company References and Other Defined Terms

As previously disclosed in our Current Report on Form 8-K filed with the SEC on August 17, 2023, on August 16, 2023, the Delaware corporation formerly known as “Diffusion Pharmaceuticals Inc.” completed a merger transaction in accordance with the terms and conditions of the Agreement and Plan of Merger, dated March 30, 2023 (the “Merger Agreement”) by and among Diffusion Pharmaceuticals Inc. (“Diffusion”), Dawn Merger Inc., a wholly-owned subsidiary of Diffusion (“Merger Sub”) and EIP Pharma, Inc. (“EIP”), pursuant to which Merger Sub merged with and into EIP, with EIP surviving the Merger a wholly-owned subsidiary of Diffusion (the “Merger”). Additionally, on August 16, 2023, Diffusion changed its name from “Diffusion Pharmaceuticals Inc.” to “CervoMed Inc.”

Prior to the Effective Time (as defined below), in connection with the transactions contemplated by the Merger Agreement, Diffusion effected a reverse stock split of the Company’s common stock, par value $0.001 per share (“common stock”), at a ratio of 1-for-1.5 (the “Reverse Stock Split”). At the Effective Time, each outstanding share of EIP capital stock was converted into the right to receive 0.1151 shares of Company common stock.

For accounting purposes, the Merger is treated as a reverse recapitalization under US GAAP and EIP is considered the accounting acquirer. Accordingly, EIP’s historical results of operations are deemed the Company’s historical results of operations for all periods prior to the Merger and, for all periods following the Merger, the results of operations of the combined company will be included in the Company’s consolidated financial statements. Following the completion of the Merger, the business conducted by the Company became primarily the business conducted by EIP.

Accordingly, unless the context otherwise requires, all references in this Quarterly Report to (i) “CervoMed,” the “Company,” “we,” “our,” or “us,” refer to the business of EIP for all dates and periods prior to August 16, 2023 and to the business of CervoMed for all dates and periods subsequent to (and including) August 16, 2023 and (ii) “common stock” refer to the common stock, par value $0.001 per share, of the Company, after giving effect to the Reverse Stock Split. Historical share and per share figures of EIP have been retroactively restated based upon the exchange ratio of 0.1151.

We have also used several other defined terms in this Quarterly Report, many of which are explained or defined below:

TermDefinition
2015 Equity PlanCervoMed Inc. 2015 Equity Incentive Plan, as amended
2018 PlanCervoMed Inc. 2018 Employee, Director and Consultant Equity Incentive Plan, as amended
2020 Notesthe previously outstanding convertible promissory notes of EIP, dated as of December 4, 2020, as amended
2021 Notesthe previously outstanding convertible promissory notes of EIP, dated as of December 10, 2021, as amended
2022 Notes Amendmentthe amendments to the 2020 Notes entered into in April 2022
2022 Sales Agreementour At-The-Market Sales Agreement, dated July 22, 2022, with BTIG, as agent
2024 Private Placementour private placement of an aggregate of 2,532,285 units, each consisting of (i) (A) one share of common stock or (B) one Pre-Funded Warrant in lieu thereof and (ii) one Series A Warrant, for aggregate gross proceeds of up to approximately $149.4 million, completed on April 1, 2024
401(k) PlanCervoMed Inc. 401(k) Defined Contribution Plan
ADAlzheimer’s Disease

ii

Annual Reportour Annual Report on Form 10-K for the year ended December 31, 2023, filed with the SEC on March 29, 2024
ASCAccounting Standard Codification of the FASB
AscenD-LB Trialour Phase 2a clinical trial evaluating neflamapimod for the treatment of patients with DLB, completed in the second half of 2021
ASUAccounting Standards Update
BFCbasal forebrain cholinergic
Boardthe board of directors of the Company
BTIGBTIG LLC
CDR-SBClinical Dementia Rating Sum of Boxes test
CMOcontract manufacturing organization
Codethe U.S. Internal Revenue Code of 1986, as amended
Convertible Notescollectively, the 2020 Notes and the 2021 Notes
CROcontract research organization
DLBdementia with Lewy bodies
Effective Timethe effective time of the Merger on August 16, 2023
Exchange ActSecurities Exchange Act of 1934, as amended
Exchange Ratiothe “Exchange Ratio” as defined in the Merger Agreement
FASBFinancial Accounting Standards Board
FDAU.S. Food and Drug Administration
FTDfrontotemporal dementia
G&Ageneral and administrative
NasdaqNasdaq Stock Market, LLC
NDANew Drug Application
NIAthe National Institute on Aging of the National Institutes of Health
NIA Grantthe $21 million grant awarded to us by the NIA in January 2023 to support the RewinD-LB Trial
p38αp38 mitogen-activated protein kinase alpha
Pre-Funded Warrantsthe pre-funded warrants each to purchase one share of common stock at a purchase price of $0.001 per share issued in connection with the 2024 Private Placement
ptau181plasma phosphorylated tau at position 181
R&Dresearch and development
Regulation S-KRegulation S-K promulgated under the Securities Act

iii

RewinD-LB Trialour Phase 2b clinical trial evaluating neflamapimod for the treatment of patients with DLB, initiated in the second quarter of 2023
ROUright-of-use
SECU.S. Securities and Exchange Commission
Section 382Section 382 of the Code
Securities ActSecurities Act of 1933, as amended
Series A Warrantsthe Series A warrants to purchase an aggregate of 2,532,285 shares of common stock at a purchase price of $39.24 per share issued in connection with the 2024 Private Placement
TUGTimed Up and Go test
U.S.United States of America
US GAAPU.S. generally accepted accounting principles
VertexVertex Pharmaceuticals Incorporated
Vertex Agreementthe Option and License Agreement, dated as of August 27, 2012, by and between EIP Pharma LLC and Vertex, as amended

Explanatory Note Regarding 2024 Private Placement

On April 1, 2024, pursuant to and in accordance with the terms of a securities purchase agreement with certain purchasers named therein, we completed the private placement of an aggregate of 2,532,285 units, each comprised of (i) (A) one share of common stock or (B) one Pre-Funded Warrant and (ii) one Series A Warrant. The aggregate upfront gross proceeds from the 2024 Private Placement were approximately $50.0 million, before deducting offering fees and expenses, and additional gross proceeds of up to approximately $99.4 million may be received if the Series A Warrants are exercised in full for cash.

The 2024 Private Placement was completed after March 31, 2024, the last day of the three-month period to which this Quarterly Report relates. Accordingly, the information contained in this Quarterly Report, including our unaudited condensed consolidated interim financial statements set forth in, “Part I — Item 1 — Financial Statements (Unaudited)” and the information regarding our liquidity, capital resources and cash runway set forth in, “Part I — Item 2 – Management’s Discussion and Analysis of Financial Condition and Results of Operations,” does not reflect the consummation of, or our receipt of proceeds from, the 2024 Private Placement. For additional information regarding the 2024 Private Placement, the terms thereof, and our expected use of the net proceeds therefrom, please refer to our Current Report on Form 8-K filed with the SEC on March 28, 2024.

Note Regarding Forward-Looking Statements

This Quarterly Report (including, for purposes of this Note Regarding Forward-Looking Statements, any information or documents incorporated herein by reference) includes express and implied forward-looking statements. By their nature, forward-looking statements involve risks and uncertainties because they relate to events, competitive dynamics and industry change, and depend on the economic circumstances that may or may not occur in the future or may occur on longer or shorter timelines than anticipated. Although we believe that we have a reasonable basis for each forward-looking statement contained in this Quarterly Report, we caution you that forward-looking statements are not guarantees of future performance and that our actual results of operations, financial condition, liquidity, and prospects may differ materially from the forward-looking statements contained in this Quarterly Report. In addition, even if our results of operations, financial condition, liquidity, and prospects are consistent with the forward-looking statements contained in this Quarterly Report, they may not be predictive of actual results or reflect unanticipated developments in future periods.

iv

Forward-looking statements appear in a number of places throughout this Quarterly Report. We may, in some cases, use terms such as “believes,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” “approximately,” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Forward-looking statements also include statements regarding our intentions, beliefs, projections, outlook, analyses or expectations concerning, among other things:

●our cash balances and our ability to obtain additional financing in the future and continue as a going concern;
●the success and timing of our ongoing RewinD-LB Trial and our other clinical and preclinical studies, including our ability to enroll subjects in our studies at anticipated rates and our ability to manufacture an adequate amount of drug supply for our studies;
●obtaining and maintaining intellectual property protection for our current or future product candidates and our proprietary technology;
●the performance of third parties, including contract research organizations, manufacturers, suppliers, and outside consultants, to whom we outsource certain operational, staff and other functions;
●our ability to obtain and maintain regulatory approval of our current or future product candidates and, if approved, our products, including the labeling under any approval we may obtain;
●our plans and ability to develop and commercialize our current or future product candidates and the outcomes of our research and development activities;
●our estimates regarding expenses, future revenues, capital requirements, and needs for additional financing;
●our future obligations under the Vertex Agreement;
●our failure to recruit or retain key scientific or management personnel or to retain our executive officers;
●the accuracy of our estimates of the size and characteristics of the potential markets for our current or future product candidates, the rate and degree of market acceptance of any of our current or future product candidates that may be approved in the future, and our ability to serve those markets;
●the success of products that are or may become available which also target the potential markets for our current or future product candidates;
●our ability to operate our business without infringing the intellectual property rights of others and the potential for others to infringe upon our intellectual property rights;
●any significant breakdown, infiltration, or interruption of our information technology systems and infrastructure;
●our ability to remediate our previously disclosed material weaknesses in our internal controls over financial reporting in a timely manner;
●our ability to successfully integrate the historical businesses of EIP and Diffusion and realize the anticipated benefits of the Merger;
●recently enacted and future legislation related to the healthcare system;
●other regulatory developments in the U.S., European Union, and other foreign jurisdictions;
●our ability to satisfy the continued listing requirements of the Nasdaq or any other exchange on which our securities may trade in the future;
●uncertainties related to general economic, political, business, industry, and market conditions, including the continued availability of funding for the NIA to support disbursements under our previously received grant; and
●other risks and uncertainties, including those discussed under the heading "Risk Factors" herein and in our other public filings.

As a result of these and other factors, known and unknown, actual results could differ materially from our intentions, beliefs, projections, outlook, analyses, or expectations expressed in any forward-looking statements in this Quarterly Report. Accordingly, we cannot assure you that the forward-looking statements contained in this Quarterly Report will prove to be accurate or that any such inaccuracy will not be material. You should also understand that it is not possible to predict or identify all such factors, and you should not consider any such list to be a complete set of all potential risks or uncertainties. In light of the foregoing and the significant uncertainties in these forward-looking statements, you should not regard these statements as a representation or warranty by us or any other person that we will achieve our objectives and plans in any specified time frame, or at all. For all forward-looking statements, we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995.

Any forward-looking statements that we make in this Quarterly Report speak only as of the date of such statement, and, except as required by applicable law or by the rules and regulations of the SEC, we undertake no obligation to update such statements to reflect events or circumstances after the date of this Quarterly Report or to reflect the occurrence of unanticipated events. Comparisons of current and any prior period results are not intended to express any ongoing or future trends or indications of future performance, unless explicitly expressed as such, and should only be viewed as historical data.

Note Regarding Trademarks, Trade Names, and Service Marks

This Quarterly Report includes trademarks, trade names, and service marks owned by us or other companies. All trademarks, service marks and trade names included in this Quarterly Report are the property of their respective owners. To the extent any such terms appear without the trade name, trademark, or service mark notice, such presentation is for convenience only and should not be construed as being used in a descriptive or generic sense.

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