CervoMed Inc
Filed May 10, 2024.
View on SEC.govAbout this filing
A company's registration of shares for sale to the public, often for a first offering. It describes the business, its risks and how the company plans to use the money.
period unavailable · Filed May 10, 2024
Contents
INTRODUCTORY NOTES
Note Regarding Company References and Other Defined Terms
As previously disclosed in our Current Report on Form 8-K filed on August 17, 2023 with the SEC, 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” or “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 prospectus 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 prospectus, many of which are explained or defined below:
| Term | Definition |
|---|---|
| 2015 Equity Plan | CervoMed Inc. 2015 Equity Incentive Plan, as amended |
| 2018 Equity 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 |
| ACA | Affordable Care Act and the Healthcare and Education Reconciliation Act |
| ACR20 | American College of Rheumatology 20 |
| AIA | America Invents Act |
| AKS | anti-kickback statute |
| Alpine Rewards | Alpine Rewards LLC, outside independent consultant to the Compensation Committee |
| ANDA | abbreviated new drug application |
| 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 |
| Audit Committee | the Audit Committee of the Board |
| Bayh-Doyle Act | Bayh-Dole Act of 1980 |
| BID | twice daily |
| BFC | basal forebrain cholinergic |
| BTIG | BTIG LLC |
| Board | the board of directors of the Company |
| Boger Trust | the Joshua S. Boger 2021 Trust DTD 12/09/2021 |
| Bylaws | the Bylaws, as amended, of the Company |
| CARES Act | Coronavirus Aid, Relief, and Economic Security Act |
| CCPA | the California Consumer Privacy Act |
|---|---|
| CPRA | the California Privacy Rights Act |
| CDR-SB | Clinical Dementia Rating Sum of Boxes test |
| CGIC | the Alzheimer’s Disease Cooperative Study-Clinician Global Impression of Change |
| cGMP | current good manufacturing practices |
| ChAT+ neurons | neurons staining positively for choline acetyl transferase |
| CMC | chemistry, manufacturing and controls |
| CMO | contract manufacturing organization |
| CMS | the U.S. Centers for Medicare & Medicaid Services |
| Compensation Committee | the Compensation Committee of the Board |
| Convertible Notes | collectively, the 2020 Notes and the 2021 Notes |
| CNS | central nervous system |
| Code | the U.S. Internal Revenue Code of 1986, as amended |
| CREATES Act | the Creating and Restoring Equal Access to Equivalent Samples Act of 2019 |
| CRL | Complete Response Letter |
| CRO | contract research organization |
| CSF | cerebrospinal fluid |
| DGCL | Delaware General Corporation Law |
| DGM | deep grey matter |
| Diffusion Registration Statement | Amendment No. 2 to our Registration Statement on Form S-4, filed with the SEC on July 11, 2023, as amended from time to time |
| DLB | dementia with Lewy bodies |
| DNP | the FDA’s Division of Neurology Products |
| DSCSA | Drug Supply Chain Security Act |
| EEA | European Economic Area |
| EEG | electroencephalogram |
| 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 |
| EIP Convertible Notes | collectively, the 2020 Notes and the 2021 Notes |
| EMA | European Medicines Agency |
| EOAD | Early Onset Alzheimer’s Disease |
| EOT | end of treatment |
| 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 |
| FCPA | the Foreign Corrupt Practices Act |
| FDA | U.S. Food and Drug Administration |
| FDCA | Federal Food, Drug, and Cosmetic Act |
| FDIC | Federal Deposit Insurance Corporation |
| FTC | Federal Trade Commission |
| FTD | frontotemporal dementia |
| GBM | glioblastoma multiforme brain cancer |
| GCP | good clinical practice |
| GDPR | European Union General Data Protection Regulation |
| GLP | good laboratory practice |
| HIPAA | the Health Insurance Portability and Accountability of Act of 1996 |
| HVLT | Hopkins Verbal Learning Test |
| IMM | irreversible morbidity and mortality |
| IND | investigational new drug application |
| IRA | Inflation Reduction Act of 2022 |
| IRB | institutional review board |
| IT | information technology |
| MA | marketing authorization |
| MCI | mild cognitive impairment |
| MRI | magnetic resonance imaging |
| MSN | medial septal nucleus |
| Nasdaq | Nasdaq Stock Market, LLC |
| NbM | Nucleus basalis of Meynert |
| NCE | new chemical entity |
| NDA | new drug application |
| NEO | named executive officer, as defined in Rule 402(m) of Regulation S-K |
|---|---|
| NGF | nerve growth factor |
| 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 |
| NTB | Neuropsychological Test Battery |
| NYSE | New York Stock Exchange |
| p38α | p38 mitogen-activated protein kinase alpha |
| PBM | pharmacy benefit manger |
| PD | Parkinson’s disease |
| PDAB | prescription drug affordability board |
| PDD | Parkinson’s disease dementia |
| PDMA | Prescription Drug Marketing Act |
| PDUFA | Prescription Drug User Fee Act, as amended |
| PET | positron emission tomography |
| POC | proof-of-concept |
| PPA | primary progressive aphasia |
| 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 |
| PREA | Pediatric Research Equity Act |
| ptau181 | plasma phosphorylated tau at position 181 |
| RA | rheumatoid arthritis |
| R&D | research and development |
| Regulation S-K | Regulation S-K promulgated under the Securities Act |
| REMS | Risk Evaluation and Mitigation Strategy |
| RewinD-LB Trial | our Phase 2b clinical trial evaluating neflamapimod for the treatment of patients with DLB, initiated in the second quarter of 2023 |
| RLD | reference-listed drug |
| SAB | scientific advisory board |
| SAE | serious adverse events |
| SEC | U.S. Securities and Exchange Commission |
| 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 |
| TCJA | Tax Cuts and Jobs Act of 2017 |
| TID | three times daily |
| TSC | trans sodium crocetinate |
| TUG | Timed Up and Go test |
| UPL | upper payment limit |
| U.S. | United States of America |
| US GAAP | U.S. generally accepted accounting principles |
| USPTO | U.S. Patent and Trademark Office |
| 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 |
The text of this filing, as the company filed it with the SEC, without its images or exhibits. This is not investment advice.