CervoMed Inc
For the period ended Jun 30, 2024. Filed Aug 9, 2024.
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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.
Jun 30, 2024 · Filed Aug 9, 2024
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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-Q
(Mark one)
| ☒ | QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the quarterly period endedJune 30, 2024** **
| ☐ | TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the transition period from ___________ to ______________.
**Commission file number:001-37942 **
**CervoMed Inc. **
(Exact name of registrant as specified in its charter)
| Delaware | 30-0645032 |
|---|---|
| (State or other jurisdiction of incorporation or organization) | (I.R.S. Employer Identification No.) |
| 20 Park Plaza, Suite 424 | |
|---|---|
| Boston, Massachusetts | 02116 |
| (Address of principal executive offices) | (Zip Code) |
**(617)744-4400 **
(Registrant’s telephone number including area code)
Securities registered pursuant to Section 12(b) of the Act:
| Title of each class | Trading Symbol(s) | Name of each exchange on which registered |
|---|---|---|
| Common Stock, par value $0.001 per share | CRVO | NASDAQ Capital Market |
Indicate by check mark whether the registrant: (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ☒ No ☐
Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes ☒ No ☐
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
| Large accelerated filer ☐ | Accelerated filer ☐ |
|---|---|
| Non-accelerated filer ☒ | Smaller reporting company ☒ |
| 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. ☐
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Act).Yes☐ No ☒
The number of shares of common stock outstanding at August 8, 2024 was 8,253,741 shares.
| Page No. | ||
|---|---|---|
| Part I | PART I – FINANCIAL INFORMATION | 1 |
| Item 1: | ITEM 1. FINANCIAL STATEMENTS | 1 |
| Item 2: | ITEM 2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS | 20 |
| Item 3: | ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK | 30 |
| Item 4: | ITEM 4. CONTROLS AND PROCEDURES | 30 |
| Part II | PART II – OTHER INFORMATION | 32 |
| Item 1: | ITEM 1. LEGAL PROCEEDINGS | 32 |
| Item 1A: | ITEM 1A. RISK FACTORS | 32 |
| Item 2: | ITEM 2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS | 32 |
| Item 3: | ITEM 3. DEFAULTS UPON SENIOR SECURITIES | 32 |
| Item 4: | ITEM 4. MINE SAFETY DISCLOSURES | 33 |
| Item 5: | ITEM 5. OTHER INFORMATION | 33 |
| Item 6: | ITEM 6. EXHIBITS | 33 |
| Signatures | 34 | |
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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 as a wholly-owned subsidiary of Diffusion (the “Merger”). At the Effective Time (as defined below), each outstanding share of EIP capital stock was converted into the right to receive 0.1151 shares of the Company's common stock and, immediately following the Effective Time, Diffusion changed its name from “Diffusion Pharmaceuticals Inc.” to “CervoMed Inc.”
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 prior to the Merger.
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” refers to the common stock, par value $0.001 per share, of the Company. 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:
| Term | Definition |
|---|---|
| 2015 Equity Plan | CervoMed Inc. 2015 Equity Incentive Plan, as amended |
| 2018 Plan | CervoMed Inc. 2018 Employee, Director and Consultant Equity Incentive Plan, as amended |
| 2020 Notes | the previously outstanding convertible promissory notes of EIP, dated as of December 4, 2020, as amended |
| 2021 Notes | the previously outstanding convertible promissory notes of EIP, dated as of December 10, 2021, as amended |
| 2022 Sales Agreement | our At-The-Market Sales Agreement, dated July 22, 2022, with BTIG, as agent |
| 2024 Private Placement | our 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) Plan | CervoMed Inc. 401(k) Defined Contribution Plan |
| AD | Alzheimer’s Disease |
| Annual Report | our Annual Report on Form 10-K for the year ended December 31, 2023, filed with the SEC on March 29, 2024 |
| ASC | Accounting Standard Codification of the FASB |
| AscenD-LB Trial | our Phase 2a clinical trial evaluating neflamapimod for the treatment of patients with DLB, completed in the second half of 2021 |
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| ASU | Accounting Standards Update |
|---|---|
| BID | twice daily |
| BFC | basal forebrain cholinergic |
| Board | the board of directors of the Company |
| BTIG | BTIG LLC |
| CDR-SB | Clinical Dementia Rating Sum of Boxes test |
| CMO | contract manufacturing organization |
| CNS | central nervous system |
| Code | the U.S. Internal Revenue Code of 1986, as amended |
| Convertible Notes | collectively, the 2020 Notes and the 2021 Notes |
| CRO | contract research organization |
| DLB | dementia with Lewy bodies |
| Early-Stage DLB | patients with DLB who have not progressed to a point where they have biomarker (e.g., elevated plasma phosphorylated tau) or imaging evidence of hippocampal atrophy (i.e., significant neuronal loss in the hippocampus) |
| Effective Time | the effective time of the Merger on August 16, 2023 |
| EIP Common Stock | the common stock, par value $0.001, of EIP issued and outstanding prior to the Merger |
| Exchange Act | Securities Exchange Act of 1934, as amended |
| Exchange Ratio | the “Exchange Ratio” as defined in the Merger Agreement |
| FASB | Financial Accounting Standards Board |
| FDA | U.S. Food and Drug Administration |
| FDIC | Federal Deposit Insurance Corporation |
| FTD | frontotemporal dementia |
| G&A | general and administrative |
| IT | information technology |
| MoCA | the Montreal Cognitive Assessment |
| Nasdaq | Nasdaq Stock Market, LLC |
| NIA | the National Institute on Aging of the National Institutes of Health |
| NIA Grant | the $21 million grant awarded to us by the NIA in January 2023 to support the RewinD-LB Trial |
| NIH | National Institutes of Health |
| NOL | net operating loss |
| p38α | p38 mitogen-activated protein kinase alpha |
| Pre-Funded Warrants | the 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 |
| ptau181 | plasma phosphorylated tau at position 181 |
| R&D | research and development |
| Regulation S-K | Regulation S-K promulgated under the Securities Act |
| RewinD-LB Trial | our Phase 2b clinical trial evaluating neflamapimod for the treatment of patients with Early-Stage DLB, initiated in the second quarter of 2023 |
| ROU | right-of-use |
| SAB | scientific advisory board |
| SEC | U.S. Securities and Exchange Commission |
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| Section 382 | Section 382 of the Code |
|---|---|
| Securities Act | Securities Act of 1933, as amended |
| Series A Warrants | the 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 |
| TID | three times daily |
| TUG | Timed Up and Go test |
| U.S. | United States of America |
| US GAAP | U.S. generally accepted accounting principles |
| Vertex | Vertex Pharmaceuticals Incorporated |
| Vertex Agreement | the Option and License Agreement, dated as of August 27, 2012, by and between EIP Pharma LLC and Vertex, as amended |
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.
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,” “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 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; |
| ● | 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; |
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| ● | 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; |
| ● | 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 those related to the upcoming U.S. elections; 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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The text of this filing, as the company filed it with the SEC, without its images or exhibits. This is not investment advice.