false
0001053691
0001053691
2026-06-09
2026-06-09
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
June 9, 2026
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)
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(Commission
File Number)
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(I.R.S. Employer
Identification No.)
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20 Park Plaza, Suite 424 Boston, Massachusetts | | 02116 |
(Address of principal executive offices)
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(Zip Code)
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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
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Trading
Symbol(s)
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Name of each exchange
on which registered
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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 1.01 Entry into a Material Definitive Agreement
On June 9, 2026, CervoMed Inc. (the “Company”) entered into a securities purchase agreement (the “Purchase Agreement”) with certain accredited investors named therein (each, an “Investor” and collectively, the “Investors”), for the private placement (the “Private Placement”) of an aggregate of 3,360,377 units (the “Units”), each Unit comprised of (i) (A) one share of the Company’s common stock, par value $0.001 per share (the “Common Stock”), or (B) one pre-funded warrant to purchase one share of Common Stock (the “Pre-Funded Warrants”), and, in each case, (ii) one Series B warrant to purchase one share of Common Stock or a pre-funded warrant to purchase one share of Common Stock (each, a “Series B Warrant”), and (iii) one Series C warrant to purchase one share of Common Stock or a pre-funded warrant to purchase one share of Common Stock (each, a “Series C Warrant”, and together with the Series B Warrants, the “Warrants”) (the shares of Common Stock issuable upon exercise of the Pre-Funded Warrants and Warrants, the “Warrant Shares”). A Unit comprised of one share of Common Stock, one Series B Warrant and one Series C Warrant shall have a purchase price of $3.14 and a Unit comprised of one Pre-Funded Warrant, one Series B Warrant and one Series C Warrant shall have a purchase price of $3.139. Joshua Boger, Ph.D., the Chair of the Board of Directors of the Company, and trusts related to John Alam, M.D., the Chief Executive Officer and a Director of the Company, and Sylvie Grégoire, PharmD, a Director of the Company, are participating in the Private Placement for an aggregate of 1,369,426 Units.
The gross proceeds for the Private Placement are expected to be approximately $10.5 million, before deducting placement agent fees and other expenses, and approximately up to an additional $21.7 million in gross proceeds if the Warrants are fully exercised for cash. The closing of the Private Placement is expected to occur on or about June 11, 2026, subject to customary closing conditions. The Private Placement is being conducted in accordance with applicable rules of The Nasdaq Stock Market LLC.
The placement agents in the Private Placement are entitled to receive a portion of a combined fee equal to approximately 6% of the aggregate gross proceeds from the securities sold in the Private Placement, plus the reimbursement of certain expenses.
The Company expects to use the net proceeds from the Private Placement to fund research and development of its clinical-stage product candidate, neflamapimod, working capital and general corporate purposes. The Company estimates, based on its current operating plan, that the net proceeds from the Private Placement, together with its current cash and cash equivalents (but excluding any additional proceeds that may be received upon the exercise of Series B Warrants or Series C Warrants), will be sufficient to fund its operations into the second quarter of 2027.
Each Pre-Funded Warrant will have an exercise price of $0.001 per Warrant Share, will be immediately exercisable on the date of issuance and will not expire. Under the terms of the Pre-Funded Warrants, the Company may not effect the exercise of any portion of any Pre-Funded Warrant, and a holder will not have the right to exercise any portion of any Pre-Funded Warrant, which, upon giving effect to such exercise, would cause a holder (together with its affiliates) to own more than a specified beneficial ownership limitation of 4.99%, 9.99% or 19.99% (as selected by such holder prior to the issuance of the Pre-Funded Warrant) of the number of shares of Common Stock outstanding immediately after giving effect to such exercise, as such percentage ownership is determined in accordance with the terms of the Pre-Funded Warrants. However, any holder may increase or decrease such percentage to any other percentage not in excess of 19.99%, provided that any increase in such percentage shall not be effective until 61 days after such notice is delivered to the Company.
The Series B Warrants shall have an exercise price equal to $3.32 per Warrant Share or $3.319 per pre-funded warrant, will be exercisable immediately and will expire five years from the issuance date of the Series B Warrant. Under the terms of the Series B Warrants, the Company may not effect the exercise of any portion of any Series B Warrant, and a holder will not have the right to exercise any portion of any Series B Warrant, which, upon giving effect to such exercise, would cause a holder (together with its affiliates) to own more than a specified beneficial ownership limitation of either 4.99%, 9.99% or 19.99% (as selected by such holder prior to the issuance of the Series B Warrant) of the number of shares of Common Stock outstanding immediately after giving effect to such exercise, as such percentage ownership is determined in accordance with the terms of the Series B Warrants. However, any holder may increase or decrease such percentage to any other percentage not in excess of 19.99%, provided that any increase in such percentage shall not be effective until 61 days after such notice is delivered to the Company. To the extent that exercise of the Series B Warrants will result in a holder thereof to beneficially own shares of Common Stock above such ownership limitations, the holder may exercise its Series B Warrants for pre-funded warrants to purchase shares of Common Stock. Such pre-funded warrants will have terms substantially similar to the Pre-Funded Warrants described above.
The Series C Warrants shall have an exercise price equal to $3.14 per Warrant Share or $3.139 per pre-funded warrant, will be exercisable immediately and will expire twelve (12) months from the issuance date of the Series C Warrant. Under the terms of the Series C Warrants, the Company may not effect the exercise of any portion of any Series C Warrant, and a holder will not have the right to exercise any portion of any Series C Warrant, which, upon giving effect to such exercise, would cause a holder (together with its affiliates) to own more than a specified beneficial ownership limitation of either 4.99%, 9.99% or 19.99% (as selected by such holder prior to the issuance of the Series C Warrant) of the number of shares of Common Stock outstanding immediately after giving effect to such exercise, as such percentage ownership is determined in accordance with the terms of the Series C Warrants. However, any holder may increase or decrease such percentage to any other percentage not in excess of 19.99%, provided that any increase in such percentage shall not be effective until 61 days after such notice is delivered to the Company. To the extent that exercise of the Series C Warrants will result in a holder thereof to beneficially own shares of Common Stock above such ownership limitations, the holder may exercise its Series C Warrants for pre-funded warrants to purchase shares of Common Stock. Such pre-funded warrants will have terms substantially similar to the Pre-Funded Warrants described above.
The exercise price and the number of Warrant Shares will be subject to appropriate adjustment in the event of certain stock dividends and distributions, stock splits, stock combinations, reclassifications or similar events affecting the Common Stock.
In the event of certain fundamental transactions (as described in the respective warrants), a holder of Pre-Funded Warrants, Series B Warrants or Series C Warrants, respectively, will have the right to receive, upon exercise of the Pre-Funded Warrants, Series B Warrants or Series C Warrants, respectively, the same amount and kind of securities, cash or property that such holder would have received had they exercised in full the Pre-Funded Warrants, Series B Warrants or Series C Warrants, respectively, immediately prior to such fundamental transaction without regard to any limitations on exercise contained in the Pre-Funded Warrants, Series B Warrants or Series C Warrants, respectively.
Pursuant to the Purchase Agreement, the Company agreed to file a registration statement with the U.S. Securities and Exchange Commission (the “SEC”) within 45 days after the closing of the Private Placement (subject to certain exceptions) for purposes of registering the resale of the shares of Common Stock and the Warrant Shares, to use its reasonable best efforts to have such registration statement declared effective within the time period set forth in the Purchase Agreement, and to keep such registration statement effective until the earliest of (i) the time as all of the shares of Common Stock and Warrant Shares purchased by the Investors pursuant to the terms of the Purchase Agreement have been sold or otherwise transferred by the holder thereof pursuant to and in a manner contemplated by the registration statement, (ii) such time as such shares of Common Stock or Warrant Shares are sold pursuant to Rule 144 under circumstances in which any legend borne by such security relating to restrictions on transferability thereof, under the Securities Act of 1933, as amended (the “Securities Act”), or otherwise, is removed by the Company, or (iii) such time as the shares of Common Stock and Warrant Shares become eligible for resale by non-affiliates without any volume limitations or other restrictions pursuant to Rule 144 under the Securities Act or any other rule of similar effect.
The Purchase Agreement contains customary representations, warranties and covenants that were made solely for the benefit of the parties to the Purchase Agreement. Such representations, warranties and covenants (i) are intended as a way of allocating risk between the parties to the Purchase Agreement and not as statements of fact and (ii) may apply standards of materiality in a way that is different from what may be viewed as material by stockholders of, or other investors in, the Company. Accordingly, the Purchase Agreement is included with this filing only to provide investors with information regarding the terms of the transaction and not to provide investors with any other factual information regarding the Company. Investors should not rely on the representations, warranties and covenants or any descriptions thereof as characterizations of the actual state of facts or condition of the Company or any of its subsidiaries or affiliates. Moreover, information concerning the subject matter of the representations and warranties may change after the date of the Purchase Agreement, which subsequent information may or may not be fully reflected in public disclosures. Additionally, the Purchase Agreement contains customary indemnification obligations of the Company and the Investors, including for liabilities under the Securities Act, and other obligations of the parties.
The Private Placement is exempt from the registration requirements of the Securities Act pursuant to the exemption for transactions by an issuer not involving any public offering under Section 4(a)(2) of the Securities Act and in reliance on similar exemptions under applicable state laws. The Investors represented that they are accredited investors within the meaning of rules promulgated under the Securities Act and were acquiring the securities for investment only and with no present intention of distributing any of such securities or any arrangement or understanding regarding the distribution thereof. The securities were offered without any general solicitation by the Company or its representatives. The securities sold and issued in the Private Placement will not be registered under the Securities Act or any state securities laws and may not be offered or sold in the United States absent registration with the SEC or an applicable exemption from the registration requirements.
The foregoing descriptions of the Purchase Agreement, Pre-Funded Warrant, Series B Warrant and Series C Warrant do not purport to be complete and are qualified in their entirety by reference to the form of Purchase Agreement, form of Pre-Funded Warrant, form of Series B Warrant and form of Series C Warrant, which are filed as Exhibit 10.1, Exhibit 4.1, Exhibit 4.2 and Exhibit 4.3, respectively, to this Current Report on Form 8-K and incorporated herein by reference.
Item 3.02 Unregistered Sales of Equity Securities
The disclosures set forth in Item 1.01 above are incorporated by reference into this Item 3.02.
Item 7.01 Regulation FD Disclosure
Press Releases
On June 10, 2026, the Company issued a press release announcing that it has entered into the Purchase Agreement and provided other business updates. A copy of the press release is attached as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.
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.” 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 SEC and other public announcements that the Company 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 is being furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that Section, nor shall it be deemed incorporated by reference into any registration statement or other filing under the Securities Act or the Exchange Act, except as shall be expressly set forth by specific reference in such filing.
Item 8.01 Other Events
The information set forth under the heading “Strategic Pipeline Priorities” in the Company’s June 10, 2026 press release attached as Exhibit 99.1 to this Current Report on Form 8-K is incorporated herein by reference.
Cautionary Note Regarding Forward-Looking Statements. Except for historical information contained in this Current Report on Form 8-K and the press release attached as Exhibit 99.1 hereto, this Current Report on Form 8-K and the press release contain forward-looking statements which involve certain risks and uncertainties that could cause actual results to differ materially from those expressed or implied by these statements. Please refer to the cautionary note in the press release attached as Exhibit 99.1 hereto regarding these forward-looking statements.
Item 9.01 Financial Statements and Exhibits
(d) Exhibits
Exhibit No. | | Description |
| | |
4.1 | | Form of Pre-Funded Warrant |
4.2 | | Form of Series B Warrant |
4.3 | | Form of Series C Warrant |
10.1 | | Form of Securities Purchase Agreement, dated June 9, 2026, by and between CervoMed Inc. and each of the Investors party thereto |
99.1 | | Press Release issued June 10, 2026 |
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: June 10, 2026 | CervoMed Inc. | |
| | | |
| By: | /s/ William Elder | |
| Name: | William Elder | |
| Title: | Chief Financial Officer & General Counsel | |
Exhibit 99.1
CervoMed Announces Private Placement Financing and Plan to Focus on Strategic Partnering to Advance Neflamapimod into Phase 3 for Dementia with Lewy Bodies
Additional funding will extend anticipated runway into second quarter of 2027
Strategic priority is to establish a partnership to advance neflamapimod into Phase 3 in dementia with Lewy bodies
Anticipated pipeline milestones over next six months include obtaining 24-week biomarker and clinical data from Phase 2a trial evaluating neflamapimod in nonfluent variant primary progressive aphasia and initiation of EXPERTS-ALS Phase 2a trial
Financing includes substantial participation from insiders and leading institutional healthcare investors
BOSTON, June 10, 2026 — CervoMed Inc. (NASDAQ: CRVO), a clinical-stage biotechnology company developing treatments for age-related brain disorders (CervoMed or the Company), today announced that it has entered into a definitive securities purchase agreement for a private placement, from which the Company anticipates upfront gross proceeds of approximately $10.5 million, before deducting offering-related fees and expenses.
The private placement financing was led by leading institutional healthcare investors, and was supported by insiders, including Joshua S. Boger, PhD, founder of Vertex Pharmaceuticals and chair of CervoMed’s board of directors, and trusts related to John J. Alam, MD, CervoMed’s president and chief executive officer, and Sylvie Grégoire, PharmD, a member of CervoMed’s board of directors. The net proceeds from the financing will extend the Company’s anticipated cash runway into the second quarter of 2027 and will support the pursuit of a strategic partnership to advance neflamapimod into Phase 3 development for the treatment of dementia with Lewy bodies (DLB).
Dr. John Alam stated: “We are extremely pleased with the momentum we have achieved in progressing neflamapimod in DLB over the past 6 months, which includes the presentation of the full clinical data from the Phase 2b RewinD-LB trial at major scientific conferences and alignment with the FDA and global regulators on a potential registration path in DLB. We believe this substantial progress, our differentiated scientific approach, and the commercial opportunity presented by the unmet medical need in DLB create a compelling opportunity for a strategic partner, and that such a partnership could provide the opportunity to generate significant value for our stockholders. In parallel with our increased focus on strategic partnering, the financing announced today provides the necessary capital to advance neflamapimod through key near-term clinical milestones in our other pipeline indications, including nonfluent variant PPA and ALS programs.”
Dr. Joshua S. Boger added: “DLB is the second most common type of progressive dementia after Alzheimer’s disease (AD) and represents a significantly underserved population where there is a substantial unfulfilled need for effective new treatments that have the ability to target the underlying cause of the disease. Neflamapimod has shown compelling Phase 2a and 2b clinical data from both an efficacy and safety perspective to date, and we believe it has significant potential to improve outcomes for patients. We are honored to have such strong support from the scientific, medical, and financial communities as we work to bring neflamapimod to those with and affected by DLB, and the physicians treating them.”
Today, the Company also provided an update on its strategic plan and priorities to advance neflamapimod in DLB and multiple rare neurological disorders.
Strategic Pipeline Priorities
Establish strategic partnership to advance Phase 3-ready neflamapimod program in DLB
| ● | Alignment with US Food and Drug Administration (FDA) on potential registration path for neflamapimod in DLB announced in November 2025, supported by data from two Phase 2 trials. Alignment with the Medicines Healthcare products Regulatory Agency in the United Kingdom (UK) and the European Medicines Agency on potential registration path for neflamapimod in DLB obtained in January 2026. |
| ● | Focus on DLB patients without AD co-pathology represents a differentiated, scientifically validated approach in a multi-billion dollar market with no approved therapies. |
| ● | Controlled manufacturing process and stable crystal form of neflamapimod announced in March 2026 mitigate past cross-batch variability issues and increase certainty of achieving target plasma drug concentrations in future studies. |
| ● | Continued momentum with recent progress, including: |
| o | Announcement of planned Phase 3 dosing regimen (50mg TID of stable crystal form), as well as manufacture and release of initial Phase 3 clinical drug batch. |
| o | Completion of a 39-week chronic toxicity study in a non-rodent species that increases neflamapimod’s no adverse effect level threefold and widens the safety margin to ~30-fold above clinically active plasma drug exposures. |
| o | Recent peer-reviewed publication validates pharmacological approach of neflamapimod in DLB, blocking the neurotoxic effects of neuroinflammation, consistent with data presented by CervoMed at ADPD 2026. |
Advance neflamapimod through upcoming clinical milestones in multiple rare neurological diseases
Nonfluent Variant Primary Progressive Aphasia (nfvPPA)
| ● | Phase 2a clinical trial designed to establish proof-of-principle of neflamapimod in nfvPPA fully enrolled ahead of schedule. |
| ● | Multiple near-term potential catalysts from ongoing Phase 2a trial anticipated, including interim biomarker data in early fourth quarter of 2026 and 24-week clinical data in the first quarter of 2027. |
| ● | Recent, peer-reviewed publication demonstrates the relevance of p38α in tauopathies, including evidence that neflamapimod reverses axonal transport deficits in mouse models of FTD-Tau. |
Amyotrophic Lateral Sclerosis (ALS)
| ● | Anticipated initiation of Phase 2a clinical trial of neflamapimod in ALS through the funded EXPERTS-ALS platform provides a capital-efficient opportunity to further expand into rare neurological disease space. |
| ● | Neflamapimod 50mg TID dose recently selected for EXPERTS-ALS Phase 2a clinical trial. |
| ● | On track for submission to regulatory authorities in the UK, with first patient dosed anticipated in the fourth quarter of 2026. |
Private Placement Financing
In the private placement, the Company will sell an aggregate of 3,360,377 units (the Units), each Unit comprised of (i) (A) one share of its common stock or (B) one pre-funded warrant to purchase shares of its common stock, (ii) one Series B warrant to purchase shares of its common stock or pre-funded warrants to purchase shares of its common stock, and (iii) one Series C warrant to purchase shares of its common stock or pre-funded warrants to purchase shares of its common stock. A Unit comprised of one share of common stock, one Series B warrant, and one Series C warrant shall have a purchase price of $3.14. A Unit comprised of one pre-funded warrant, one Series B warrant, and one Series C warrant shall have a purchase price of $3.139.
The Series B warrants have an exercise price of $3.32 per share (or $3.319 per pre-funded warrant), will be immediately exercisable, and will expire on June 11, 2031. The Series C warrants have an exercise price of $3.14 per share (or $3.139 per pre-funded warrant), will be immediately exercisable, and will expire on June 11, 2027. The pre-funded warrants have an exercise price of $0.001 per share, will be immediately exercisable, and will not expire.
The Company anticipates gross proceeds from the private placement will be approximately $10.5 million, before deducting any offering-related fees and expenses, and up to an additional approximately $21.7 million in gross proceeds if the Series B warrants and Series C warrants are fully exercised for cash. The private placement is expected to close on or about June 11, 2026, subject to customary closing conditions.
The Company intends to use the net proceeds from the private placement to fund research and development of its clinical-stage product candidate, neflamapimod, working capital and general corporate purposes. Based on the Company’s current operating plan, the proceeds from this financing (together with the Company’s existing cash and cash equivalents but excluding any additional proceeds that may be received upon the exercise of Series B warrants or Series C warrants), are expected to fund operations into the second quarter of 2027.
The offer and sale of the foregoing securities are being made in a transaction not involving a public offering and the securities to be sold in the private placement have not been registered under the Securities Act of 1933, as amended (Securities Act), or any state or other applicable jurisdiction’s securities laws, and may not be offered or sold in the United States absent registration or an applicable exemption from the registration requirements of the Securities Act and applicable state or other jurisdictions’ securities laws. Pursuant to the securities purchase agreement, the Company has agreed to file a registration statement with the US Securities and Exchange Commission (SEC) registering the resale of the shares of common stock issued in the private placement and the shares of common stock issuable upon the exercise of the pre-funded warrants, the Series B warrants (including upon exercise of any pre-funded warrants issued upon exercise of the Series B warrants), and the Series C warrants (including upon exercise of any pre-funded warrants issued upon exercise of the Series C warrants) issued in the private placement no later than the 45th day after the closing of the private placement.
This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any offer, solicitation or sale of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful. Any offering of the securities under the resale registration statement will only be made by means of a prospectus.
About Neflamapimod
Neflamapimod is an investigational, orally administered small-molecule drug that readily crosses the blood-brain barrier and selectively inhibits the alpha isoform of p38 MAP kinase, a key driver of neuroinflammation and synaptic dysfunction. By targeting the critical disease processes underlying degenerative disorders of the brain, neflamapimod has the potential to reverse synaptic dysfunction, improve neuron health, and slow or prevent disease progression. Neflamapimod is currently in clinical development for the treatment of DLB, nfvPPA, and recovery after ischemic stroke, and CervoMed expects the first patient to be dosed with neflamapimod in the EXPERTS-ALS Phase 2a clinical trial in the fourth quarter of 2026.
In non-clinical studies, neflamapimod restored synaptic function within the basal forebrain cholinergic system, the brain region most affected in DLB. Across Phase 1 and 2 clinical trials involving more than 800 participants, the drug has been generally well tolerated and demonstrated consistent signals of efficacy. In the 91-patient Phase 2a AscenD-LB trial, neflamapimod significantly improved dementia severity and functional mobility in patients with DLB. Results from the 159-patient Phase 2b RewinD-LB trial, a 16-week randomized, double-blind, placebo-controlled trial followed by a 32-week open-label extension, further supported neflamapimod’s potential to deliver meaningful clinical benefit, improving both cognitive and functional outcomes and showing a positive effect on a key blood biomarker of neurodegeneration during the extension phase. Across both studies, the greatest benefits were observed in patients without AD co-pathology. Collectively, these findings underscore the therapeutic promise and scientific validity of neflamapimod as a potential treatment for DLB and other degenerative brain disorders.
About CervoMed
CervoMed is a clinical-stage company developing treatments for age-related brain disorders. Its lead drug candidate, neflamapimod, is an oral small molecule targeting critical disease processes underlying degenerative disorders of the brain by inhibiting a key enzyme involved in neuroinflammation and neurodegeneration. CervoMed’s recently completed Phase 2b RewinD-LB trial evaluated neflamapimod in patients with DLB, enriched for those without AD co-pathology, and the Company announced alignment with the FDA on a potential registration path for neflamapimod in DLB in November 2025. Initiation of a Phase 3 trial in DLB is subject to the establishment of a partnership and/or additional financing. CervoMed also recently completed enrollment in its ongoing Phase 2a clinical trial evaluating neflamapimod in nfvPPA, a subtype of frontotemporal disorders, from which interim biomarker data is anticipated in the early fourth quarter of 2026, and expects the first patient to be dosed with neflamapimod in the EXPERTS-ALS Phase 2a clinical trial in the fourth quarter of 2026.
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 timing, size and expectation of the closing of the private placement; expectations regarding market conditions, the satisfaction of customary closing conditions related to the private placement and the anticipated use of proceeds therefrom; whether any pre-funded warrants, Series B warrants, or Series C warrants issued in the private placement will be exercised in full or at all; the Company’s anticipated cash runway; the Company’s need to acquire sufficient funding, including funding for any Phase 3 trial in patients with DLB; the Company’s plan to focus on strategic partnering to advance neflamapimod into Phase 3 for DLB; the therapeutic potential of neflamapimod in DLB, nfvPPA, ALS, or any other indication, including the degree of sustainability of any therapeutic effects; the anticipated timing and achievement of clinical and development milestones, including the Company’s initiation of any Phase 3 trial in patients with DLB; the anticipated data readouts from the Company’s Phase 2a trial in nfvPPA and the anticipated dosing of the first patient with neflamapimod in the EXPERTS-ALS trial; any other expected or implied benefits or results, including the extent (if any) to which neflamapimod may demonstrate efficacy or other clinical or biomarker improvements in patients; and expectations with respect to neflamapimod, including the timing of any regulatory submissions and potential approvals thereof, if any, in DLB or any other indication. Terms such as “believes,” “estimates,” “anticipates,” “expects,” “plans,” “aims,” “seeks,” “intends,” “may,” “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 satisfaction of the closing conditions to and consummation of the Company’s anticipated private placement; the Company’s available cash resources, the availability of additional funds on acceptable terms or at all, and the Company’s ability to continue as a going concern; the results of the Company’s clinical trials; the Company’s ability to successfully enter into a partnership to advance neflamapimod into Phase 3 for DLB in a timely manner, on acceptable terms, or at all; the likelihood and timing of any regulatory approval of neflamapimod or the nature of any feedback the Company may receive from the FDA or other regulators; 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, 2025 filed with the SEC on March 13, 2026, 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.
Contacts
Media:
Lisa Guiterman
Biongage Communications
lisa.guiterman@gmail.com
202-330-3431
Investor Relations:
Argot Partners
cervomed@argotpartners.com
212-600-1902
