sava20260331

sava20260331_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 March 31, 2026

☐ 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: 001-41905

Filana Therapeutics, Inc.

(Exact name of registrant as specified in its charter)

	Delaware	91-1911336
	(State or other jurisdiction of	(I.R.S. Employer
	incorporation or organization)	Identification Number)

6801 N. Capital of Texas Highway, Building 1; Suite 300, Austin, TX 78731

(512) 501-2444

(Address, including zip code, of registrant’s principal executive offices and

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, $0.001 par value

FLNA

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, a 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 Exchange Act). Yes ☐ No ☑

Indicate the number of shares outstanding of each of the issuer’s classes of common stock, as of the latest practicable date.

	Common Stock, $0.001 par value	48,307,896
		Shares Outstanding as of May 4, 2026

		Page No.
PART I.	FINANCIAL INFORMATION

Item 1.	Financial Statements

	Condensed Consolidated Balance Sheets – March 31, 2026 and December 31, 2025	3

	Condensed Consolidated Statements of Operations – Three Months Ended March 31, 2026 and 2025	4

	Condensed Consolidated Statements of Changes in Stockholders’ Equity - Three Months Ended March 31, 2026 and 2025	5

	Condensed Consolidated Statements of Cash Flows – Three Months Ended March 31, 2026 and 2025	6

	Notes to Condensed Consolidated Financial Statements	7

Item 2.	Management’s Discussion and Analysis of Financial Condition and Results of Operations	17

Item 3.	Quantitative and Qualitative Disclosures About Market Risk	27

Item 4.	Controls and Procedures	27

PART II.	OTHER INFORMATION

Item 1.	Legal Proceedings	27

Item 1A	Risk Factors	27

Item 2.	Unregistered Sales of Equity Securities and Use of Proceeds	28

Item 3.	Defaults Upon Senior Securities	28

Item 4.	Mine Safety Disclosures	28

Item 5.	Other Information	28

Item 6.	Exhibits	29

Signatures	30

	*March 31, 2026*			*December 31, 2025*

*ASSETS*
Current assets:
Cash and cash equivalents	$	86,573		$	95,502
Prepaid expenses and other current assets		1,391			2,207
Total current assets		87,964			97,709
Property and equipment, net		20,403			20,646
Total assets	$	108,367		$	118,355

*LIABILITIES AND STOCKHOLDERS' EQUITY*
Current liabilities:
Accounts payable and accrued expenses	$	39,189		$	41,647
Accrued development expense		605			364
Accrued compensation and benefits		246			1,625
Other current liabilities		75			198
Total current liabilities		40,115			43,834
Other non-current liabilities		111			118
Total liabilities		40,226			43,952
Commitments and contingencies (Notes 8, 9 and 10)
Stockholders' equity:
Preferred stock, $0.001 par value; 10,000,000 shares authorized, none issued and outstanding		—			—
Common stock, $0.001 par value; 120,000,000 shares authorized; 48,307,896 shares issued and outstanding at March 31, 2026 and December 31, 2025		48			48
Additional paid-in capital		574,508			570,439
Accumulated deficit		(506,415	)		(496,084	)
Total stockholders' equity		68,141			74,403
Total liabilities and stockholders' equity	$	108,367		$	118,355

	*Three months ended*
	*March 31,*
	*2026*			*2025*
Operating expenses:
Research and development	$	4,544		$	13,666
General and administrative		6,624			10,920
Total operating expenses		11,168			24,586
Operating loss		(11,168	)		(24,586	)
Interest income		789			1,265
Other income (loss), net		48			(82	)
Net loss	$	(10,331	)	$	(23,403	)

Net loss per share, basic and diluted	$	(0.21	)	$	(0.48	)

										*Total*
	*Common stock*				*Additional*		*Accumulated*			*stockholders'*
	*Shares*		*Par value*		*paid-in capital*		*deficit*			*equity*
Balance at December 31, 2024		48,203,179	$	48	$	550,767	$	(405,111	)	$	145,704
Stock-based compensation for:
Stock options for employees		—		—		5,189		—			5,189
Stock options for non-employees		—		—		36		—			36
Issuance of common stock pursuant to exercise of stock options		104,717		—		90		—			90
Net income		—		—		—		(23,403	)		(23,403	)
Balance at March 31, 2025		48,307,896	$	48	$	556,082	$	(428,514	)	$	127,616

Balance at December 31, 2025		48,307,896	$	48	$	570,439	$	(496,084	)	$	74,403
Stock-based compensation for:
Stock options for employees		—		—		4,053		—			4,053
Stock options for non-employees		—		—		16		—			16
Net loss		—		—		—		(10,331	)		(10,331	)
Balance at March 31, 2026		48,307,896	$	48	$	574,508	$	(506,415	)	$	68,141

	*Three months ended March 31,*
	*2026*			*2025*
Cash flows from operating activities:
Net loss	$	(10,331	)	$	(23,403	)
Adjustments to reconcile net loss to net cash used in operating activities:
Stock-based compensation		4,069			5,225
Depreciation and amortization		243			220
Changes in operating assets and liabilities:
Prepaid and other current assets		867			5,135
Accounts payable and accrued expenses		(2,458	)		538
Accrued development expense		241			1,637
Accrued compensation and benefits		(1,379	)		(502	)
Other liabilities		(130	)		(186	)
Net cash used in operating activities		(8,878	)		(11,336	)
Cash flows from financing activities:
2025 ATM program offering costs		(51	)		—
Proceeds from issuance of common stock upon exercise of stock options		—			90
Net cash (used in) provided by financing activities		(51	)		90
Net decrease in cash and cash equivalents		(8,929	)		(11,246	)
Cash and cash equivalents at beginning of period		95,502			128,574
Cash and cash equivalents at end of period	$	86,573		$	117,328

	*March 31,*		*December 31,*
	*2026*		*2025*
Prepaid insurance	$	253	$	493
Contract research organization and other deposits		801		1,530
Interest receivable		117		120
Other		220		64
Total prepaid expenses and other current assets	$	1,391	$	2,207

For the year ending December 31,
2026			0.6
2027			0.6
2028			0.5
2029			0.5
2030 and beyond			1.0
Total gross rental income			3.2

	*Stock Options*		*Performance Awards*
Outstanding as of December 31, 2025		4,157,094		7,142
Options granted		—		—
Options exercised		—		—
Options forfeited/canceled		—		—
Outstanding as of March 31, 2026		4,157,094		7,142

	●	the timing and conduct of our planned and future potential clinical trials and studies for Simufilam in Tuberous Sclerosis Complex (TSC) and additional indications, including the timing of initiation, enrollment and completion of the trials and the period during which the results of the trials will become available;
	●	the safety profile or treatment benefits, if any, of simufilam;
	●	our ability to conduct planned preclinical studies of simufilam relating to epilepsy in TSC;
	●	our ability to initiate, conduct or analyze additional clinical and non-clinical studies with our product candidates targeted at central nervous system disorders, including TSC-related epilepsy;
	●	our ability to successfully carry out our obligations under our license agreement with Yale, for which we have assumed all responsibility for global development and commercialization for simufilam for the treatment of TSC-related epilepsy;
	●	our plans or ability to expand therapeutic indications for simufilam outside of TSC-related epilepsy;
	●	our reliance on third-party contractors to conduct all of our clinical and non-clinical trials and to make drug supply, or their ability to do so on-time or on-budget;
	●	the interpretation of data from our pre-clinical or early clinical studies, such as Phase 1 and Phase 2 studies, and any studies that are not randomized controlled trials;
	●	the impact of pre-clinical findings on our ability to develop our product candidates;
	●	our use of exploratory ‘research use only’ non-safety related biomarkers in our clinical studies;
	●	our ability to file for and obtain regulatory approval of our product candidates;
	●	our strategy and ability to establish an infrastructure to commercialize any product candidates, if approved;
	●	the potential future revenues of our product candidates, if approved and commercialized;
	●	the market acceptance of our product candidates, if approved and commercialized;
	●	the pricing and reimbursement of our product candidates, if approved and commercialized;
	●	the utility of protection, or the sufficiency, of our intellectual property;
	●	our potential competitors or competitive products for therapeutic areas we may elect to pursue;
	●	our need to raise new capital from time to time to finance our operations and the impact of macroeconomic conditions on our ability to effectively raise capital;
	●	expectations regarding trade secrets, technological innovations, licensing agreements and outsourcing of certain business functions;
	●	our expenses or incurred costs increasing by material amounts in excess of budgeted amounts due to unexpected cost overruns, imperfect forecasting, increased scope of activities or other causes;
	●	fluctuations in our financial or operating results;
	●	our operating losses, anticipated operating and capital expenditures and legal expenses;
	●	expectations regarding the issuance of shares of common stock, options or other equity to employees or directors pursuant to equity compensation awards, net of employment taxes;
	●	the development and maintenance of our internal information systems and infrastructure;

	●	our ability to minimize the likelihood and impact of adverse cybersecurity incidents in our information systems and infrastructure;
	●	our ability to attract and retain personnel;
	●	existing or emerging regulations and regulatory developments in the United States and other jurisdictions in which we operate;
	●	our expectations regarding the appropriate size and scope of our operations;
	●	the sufficiency of our cash resources to continue to fund our operations;
	●	potential future agreements with third parties in connection with the commercialization of our product candidates;
	●	the accuracy of our estimates regarding expenses, loss contingency reserves, capital requirements, and needs for additional financing;
	●	assumptions and estimates used for our disclosures regarding stock-based compensation;
	●	expense, timing and outcome of pending or future litigation or other legal proceedings and claims (including U.S. government inquiries) including the potential for negotiated settlements of such matters; and
	●	litigation, claims or other uncertainties that may arise from allegations made against us or our former employees or collaborators and the potential resolution of same.

	*March 31,*			*December 31,*
	*2026*			*2025*
Land	$	3,734		$	3,734
Buildings		15,980			15,980
Site improvements		494			494
Tenant improvements		3,468			3,468
Furniture and equipment		891			891
Construction in progress		25			25
Other		181			193
Gross property and equipment	$	24,773		$	24,785
Accumulated depreciation		(4,370	)		(4,139	)
Property and equipment, net	$	20,403		$	20,646

	●	a 12-month, open-label treatment phase, followed by
	●	a 6-month randomized, placebo-controlled withdrawal phase, followed by
	●	6 additional months of open-label treatment.

	Three months ended
	March 31,
	2026		2025
Clinical trials	$	102	$	8,095
Pre-clinical projects		959		715
Chemical, Manufacturing and Controls costs (“CMC costs”)		703		383
Personnel related		1,103		1,725
Stock-based compensation		1,333		2,372
Other		344		376
	$	4,544	$	13,666

		Incorporated by
		Reference
Exhibit	Description		Filing	Exhibit	Filed
No.		Form	Date	No.	Herewith
3.1	Amended and Restated Certificate of Incorporation.	10-Q	7/29/2005	3.1
3.2	Certificate of Amendment of Restated Certificate of Incorporation.	8-K	5/8/2017	3.1
3.3	Certificate of Amendment of Restated Certificate of Incorporation.	10-K	3/29/2019	3.3
3.4	Certificate of Amendment of Restated Certificate of Incorporation.	8-K	3/10/2026	3.4
3.5	Amended and Restated Bylaws of Filana Therapeutics, Inc.	8-K	3/10/2026	3.5
31.1	Certification of Principal Executive Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.				X
31.2	Certification of Principal Financial Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.				X
32.1+	Certification of the Chief Executive Officer and the Chief Financial Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.				X
101.INS	Inline XBRL Instance Document - (the instant document does not appear in the Interactive Data File because its XBRL tags are embedded within the Inline XBRL document).				X
101.SCH	Inline XBRL Taxonomy Extension Schema Document.				X
101.CAL	Inline XBRL Taxonomy Extension Calculation Linkbase Document.				X
101.DEF	Inline XBRL Taxonomy Extension Definition Linkbase Document.				X
101.LAB	Inline XBRL Taxonomy Extension Labels Linkbase Document.				X
101.PRE	Inline XBRL Taxonomy Extension Presentation Linkbase Document.				X
104	Cover Page Interactive Data File –(formatted as Inline XBRL and contained in Exhibit 101).				X

	●	engage with, and satisfactorily respond to, requests for additional information from the FDA concerning the clinical hold on our IND application for simufilam in TSC-related epilepsy
	●	conduct preclinical and clinical studies for our product candidates, including simufilam for TSC-related epilepsy;
	●	seek regulatory approvals for our product candidates;
	●	develop, formulate, manufacture and commercialize our product candidates;
	●	acquire or in-license additional products or technologies, or expand the use of our technology;
	●	maintain, defend and expand the scope of our intellectual property; and
	●	expend resources related to legal proceedings and claims, including U.S. government inquiries.

	●	clinical trials,
	●	pre-clinical testing,
	●	clinical supplies and related formulation and design costs, and
	●	compensation and other personnel-related expenses.

	Three months ended March 31,
	2026			2025

Net cash used in operating activities	$	(8,878	)	$	(11,336	)
Net cash used in investing activities		—			—
Net cash provided by (used in) financing activities		(51	)		90
Net decrease in cash and cash equivalents	$	(8,929	)	$	(11,246	)

	Filana Therapeutics, Inc.
	(Registrant)

	/s/ RICHARD J. BARRY
	Richard J. Barry,
	President and Chief Executive Officer
Date: May 7, 2026	(Principal Executive Officer)




	/s/ ERIC J. SCHOEN
	Eric J. Schoen,
	Chief Financial Officer
Date: May 7, 2026	(Principal Financial and Accounting Officer)

SEC Form 10-Q filed by Filana Therapeutics Inc.