crvo20250930

crvo20250930_10q.htm

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 ended September 30, 2025

☐

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 November 5, 2025 was 9,252,719 shares.

CervoMed Inc.

		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	32

Item 4:	ITEM 4. CONTROLS AND PROCEDURES	32

Part II	PART II – OTHER INFORMATION	34

Item 1:	ITEM 1. LEGAL PROCEEDINGS	34

Item 1A:	ITEM 1A. RISK FACTORS	34

Item 2:	ITEM 2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS	35

Item 3:	ITEM 3. DEFAULTS UPON SENIOR SECURITIES	35

Item 4:	ITEM 4. MINE SAFETY DISCLOSURES	35

Item 5:	ITEM 5. OTHER INFORMATION	35

Item 6:	ITEM 6. EXHIBITS	35

Signatures		36

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 Sub 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.”

For accounting purposes, the Merger is treated as a reverse recapitalization under U.S. 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 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 “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.

We have also used several other defined terms in this Quarterly Report on Form 10-Q (the "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
2025 Equity Plan	CervoMed Inc. 2025 Equity Incentive Plan
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, 2024, filed with the SEC on March 17, 2025
ADCS-CGIC	Alzheimer's Disease Cooperative Study — Clinical Global Impression of Change
ASC	Accounting Standard Codification of the FASB
ASU 2023-09	ASU No. 2023-09, Income Taxes (Topic 740): “Improvements to Income Tax Disclosures”
AscenD-LB Trial	our Phase 2a clinical trial evaluating neflamapimod for the treatment of patients with DLB, completed in the second half of 2021
ASU	Accounting Standards Update
Batch A	the batch of neflamapimod drug product capsules manufactured in October 2020 and administered for the Initial Phase of the RewinD-LB Trial and a portion of the Extension that did not achieve mean target plasma drug concentrations, also referred to as the “Old Capsules”
Batch B	the batch of neflamapimod drug product capsules manufactured in March 2023 and administered for the majority of the RewinD-LB Trial Extension phase that achieved mean target plasma drug concentrations, also referred to as the “New Capsules”

BFC	basal forebrain cholinergic
Board	the board of directors of the Company
CDMO	contract development and manufacturing organization
CDR-SB	Clinical Dementia Rating Sum of Boxes test
CMC	chemistry, manufacturing and controls
CODM	chief operating decision maker
common stock	the Company’s common stock, par value $0.001 per share
CRO	contract research organization
DLB	dementia with Lewy bodies
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
Extension or Extension Phase	with respect to the RewinD-LB Trial, the 32-week extension phase of the trial from which 16-week results were reported in March 2025
FASB	Financial Accounting Standards Board
FDA	U.S. Food and Drug Administration
FTD	frontotemporal dementia
GFAP	glial fibrillary acidic protein
Initial Phase	with respect to the RewinD-LB Trial, the initial 16-week double-blind, placebo controlled phase of the trial from which topline results were reported in December 2024
IT	information technology
Nasdaq	the Nasdaq Stock Market LLC
NDA	New Drug Application
NIA	the National Institute on Aging of the National Institutes of Health
NIA Grant	the $21.3 million grant awarded to us by the NIA to support the RewinD-LB Trial, $21.0 million of which was awarded in January 2023 and an additional $0.3 million of which was awarded in August 2024
NIH	National Institutes of Health
p38α	p38 mitogen-activated protein kinase alpha
plasma ptau181	plasma phosphorylated tau at position 181. Prior to October 2025, the Company historically reported plasma ptau181 levels based on the scale associated with the Quanterix Simoa ptau181 Advantage v2.0 assay kit, which was utilized in the AscenD-LB Trial. In this Quarterly Report, the Company reports plasma ptau181 levels based on the scale associated with the current Quanterix Simoa ptau181 Advantage v2.1 assay kit, which was utilized in the RewinD-LB trial. Quantitative values on the v2.1 scale are approximately ten-fold higher than the corresponding values on the v2.0 scale.
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
Pure DLB	DLB with low likelihood of AD co-pathology
Regulation S-K	Regulation S-K promulgated under the Securities Act
RESTORE Trial	our ongoing Phase 2a clinical trial evaluating neflamapimod for the treatment of patients recovering from ischemic stroke, which the Company initiated in the second quarter of 2025
RewinD-LB Trial	our Phase 2b clinical trial evaluating neflamapimod for the treatment of patients with DLB, from which we announced final results in October 2025
ROU	right-of-use
Sales Agreement	Sales Agreement, dated May 12, 2025, by and between the Company and Leerink Partners LLC
SEC	U.S. Securities and Exchange Commission

iii

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
U.S.	United States of America
U.S. 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,” “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 and continue as a going concern;
	●	the success and timing of our ongoing and planned clinical trials and preclinical studies, including our ability to enroll participants 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 CROs, CDMOs, manufacturers, suppliers, and outside consultants, to whom we outsource certain operations, 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 IT 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 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.

PART I – FINANCIAL INFORMATION

ITEM 1.

FINANCIAL STATEMENTS

CervoMed Inc.

Condensed Consolidated Balance Sheets

(unaudited)

	September 30, 2025			December 31, 2024
Assets
Current assets:
Cash and cash equivalents	$	9,437,400		$	8,999,496
Marketable securities		17,856,688			29,922,523
Prepaid expenses and other current assets		1,685,972			1,905,360
Deferred offering costs		269,331			—
Grant receivable		1,361,387			2,254,231
Total current assets		30,610,778			43,081,610
Total assets	$	30,610,778		$	43,081,610
Liabilities and Stockholders’ Equity
Current liabilities:
Accounts payable	$	1,349,219		$	1,511,440
Accrued expenses and other current liabilities		3,250,095			2,367,842
Total liabilities		4,599,314			3,879,282
Commitments and Contingencies (Note 8)
Stockholders’ Equity:
Series A preferred stock $0.001 par value: 30,000,000 authorized at September 30, 2025 and December 31, 2024, 0 shares issued and outstanding at September 30, 2025 and December 31, 2024		—			—
Common stock, $0.001 par value: 1,000,000,000 shares authorized at September 30, 2025 and December 31, 2024: 9,252,719 and 8,702,719 shares issued and outstanding at September 30, 2025 and December 31, 2024, respectively		9,252			8,702
Additional paid-in capital		115,606,949			109,868,913
Accumulated other comprehensive income		5,824			56,197
Accumulated deficit		(89,610,561	)		(70,731,484	)
Total stockholders' equity		26,011,464			39,202,328
Total liabilities and stockholders' equity	$	30,610,778		$	43,081,610

See accompanying notes to unaudited condensed consolidated interim financial statements

CervoMed Inc.

Condensed Consolidated Statements of Operations and Comprehensive Loss

(unaudited)

	Three Months Ended September 30,						Nine Months Ended September 30,
	2025			2024			2025			2024
Grant revenue	$	322,569		$	1,939,751		$	3,997,784		$	7,575,972
Operating expenses:
Research and development		6,040,442			5,125,097			15,986,865			11,711,746
General and administrative		2,326,326			2,210,927			7,974,277			6,850,536
Total operating expenses		8,366,768			7,336,024			23,961,142			18,562,282
Loss from operations		(8,044,199	)		(5,396,273	)		(19,963,358	)		(10,986,310	)
Other income (expense):
Other expense		(1,227	)		(3,440	)		(11,618	)		(3,717	)
Interest income		318,787			646,172			1,095,899			1,405,246
Total other income, net		317,560			642,732			1,084,281			1,401,529
Net loss	$	(7,726,639	)	$	(4,753,541	)	$	(18,879,077	)	$	(9,584,781	)
Per share information:
Net loss per share of common stock, basic and diluted	$	(0.84	)	$	(0.55	)	$	(2.10	)	$	(1.22	)
Weighted average shares outstanding, basic and diluted		9,252,719			8,702,764			8,970,668			7,861,757
Net loss:
Net unrealized gain (loss) on marketable securities		6,607			142,864			(50,373	)		123,162
Total comprehensive loss	$	(7,720,032	)	$	(4,610,677	)	$	(18,929,450	)	$	(9,461,619	)

See accompanying notes to unaudited condensed consolidated interim financial statements

CervoMed Inc.

Condensed Consolidated Statements of Stockholders’ Equity

(unaudited)

	Three Month Period Ended September 30, 2025
	Common Stock				Additional Paid-in		Accumulated other comprehensive			Accumulated			Total Stockholders'
	Shares		Amount		Capital		(loss) income			Deficit			Equity
Balance at June 30, 2025		9,252,719	$	9,252	$	115,315,232	$	(783	)	$	(81,883,922	)	$	33,439,779
Unrealized gain on marketable securities		—		—		—		6,607			—			6,607
Stock-based compensation expense		—		—		291,717		—			—			291,717
Net loss		—		—		—		—			(7,726,639	)		(7,726,639	)
Balance at September 30, 2025		9,252,719	$	9,252	$	115,606,949	$	5,824		$	(89,610,561	)	$	26,011,464

	Nine Month Period Ended September 30, 2025
	Common Stock				Additional Paid-in		Accumulated other comprehensive			Accumulated			Total Stockholders'
	Shares		Amount		Capital		(loss) income			Deficit			Equity
Balance at December 31, 2024		8,702,719	$	8,702	$	109,868,913	$	56,197		$	(70,731,484	)	$	39,202,328
Unrealized loss on marketable securities		—		—		—		(50,373	)		—			(50,373	)
Stock-based compensation expense		—		—		1,149,899		—			—			1,149,899
Sale of common stock, net of issuance costs		550,000		550		4,588,137		—			—			4,588,687
Net loss		—		—		—		—			(18,879,077	)		(18,879,077	)
Balance at September 30, 2025		9,252,719	$	9,252	$	115,606,949	$	5,824		$	(89,610,561	)	$	26,011,464

	Three Month Period Ended September 30, 2024
	Common Stock				Additional Paid-in		Accumulated other comprehensive			Accumulated			Total Stockholders'
	Shares		Amount		Capital		(loss) income			Deficit			Equity
Balance at June 30, 2024		8,253,741	$	8,253	$	109,260,436	$	(19,702	)	$	(59,272,029	)	$	49,976,958
Stock-based compensation expense		—		—		271,215		—			—			271,215
Unrealized gain on marketable securities		—		—		—		142,864			—			142,864
Net loss		—		—		—		—			(4,753,541	)		(4,753,541	)
Balance at September 30, 2024		8,253,741	$	8,253	$	109,531,651	$	123,162		$	(64,025,570	)	$	45,637,496

	Nine Month Period Ended September 30, 2024
	Common Stock				Additional Paid-in			Accumulated other comprehensive		Accumulated			Total Stockholders'
	Shares		Amount		Capital			(loss) income		Deficit			Equity
Balance at December 31, 2023		5,674,520	$	5,674	$	61,811,889		$	—	$	(54,440,789	)	$	7,376,774
Issuance of common stock, pre-funded warrants and common stock warrants, net of offering costs		2,083,262		2,083		46,396,523			—		—			46,398,606
Stock options granted in lieu of compensation		—		—		255,724			—		—			255,724
Cashless exercise of pre-funded warrants		495,959		496		(496	)		—		—			—
Stock-based compensation expense		—		—		1,068,011			—		—			1,068,011
Unrealized loss on marketable securities		—		—		—			123,162		—			123,162
Net loss		—		—		—			—		(9,584,781	)		(9,584,781	)
Balance at September 30, 2024		8,253,741	$	8,253	$	109,531,651		$	123,162	$	(

SEC Form 10-Q filed by CervoMed Inc.