Talphera (Nasdaq: TLPH) details 2025 loss, cash and NEPHRO CRRT progress

Rhea-AI Filing Summary

Talphera, Inc. reported fourth quarter and full year 2025 results and updated progress on its NEPHRO CRRT registrational study for Niyad, a nafamostat-based anticoagulant. For Q4 2025, the company recorded no revenue and a net loss of $3.8 million, compared with a net loss of $1.9 million a year earlier. For full year 2025, revenue was $28,000 and net loss was $14.3 million versus a net loss of $13.0 million in 2024, while total operating expenses declined to about $13.5 million from $15.3 million. Cash, cash equivalents and investments were $20.4 million at December 31, 2025, up from $8.9 million a year earlier, supported in part by closing a $4.1 million financing tranche linked to 50% enrollment in the NEPHRO CRRT study. The trial has enrolled 35 of 70 planned patients, with all 12 active sites able to recruit, and completion is expected in 2026. Talphera guided 2026 cash operating expenses to $17–18 million and scheduled a virtual investor and analyst day to discuss its business and clinical progress.

Insights

Biotech equity analyst

Development progress continues, but losses persist and cash usage remains central.

Talphera remains a development-stage company with minimal 2025 revenue of $28,000 and a full-year net loss of $14.3 million. Operating expenses fell to roughly $13.5 million, showing some cost discipline while the NEPHRO CRRT registrational study advances.

Cash, cash equivalents and investments of $20.4 million at December 31, 2025, plus a recently closed $4.1 million financing tranche, underpin operations. The company expects 2026 cash operating expenses of $17–18 million, so capital efficiency and any additional funding steps are important considerations.

Clinically, 35 of 70 patients are enrolled in the NEPHRO CRRT study, with all 12 sites able to recruit and completion expected in 2026. Future disclosures around enrollment pace, top-line results and any regulatory interactions for Niyad will be key to understanding potential value creation.

8-K Event Classification

2 items: 2.02, 9.01

2 items

Item 2.02 Results of Operations and Financial Condition Financial

Disclosure of earnings results, typically an earnings press release or preliminary financials.

Item 9.01 Financial Statements and Exhibits Exhibits

Financial statements, pro forma financial information, and exhibit attachments filed with this report.

Understanding 8-K Material Events →

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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

Date of Report (Date of earliest event reported): March 23, 2026

TALPHERA, INC.

(Exact name of registrant as specified in its charter)

Delaware		001-35068		41-2193603
(State of incorporation)		(Commission File No.)		(IRS Employer Identification No.)

1850 Gateway Drive, Suite 175

San Mateo, CA 94404

(Address of principal executive offices and zip code)

Registrant’s telephone number, including area code: (650) 216-3500

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 (see General Instruction A.2. below):

☐ 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))

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	TLPH	The 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 2.02 Results of Operations and Financial Condition

On March 23, 2026, Talphera, Inc. (the “Company”) issued a press release announcing its financial results for the three and twelve months ended December 31, 2025 and providing a corporate update (the “Release”). A copy of the Release is furnished herewith as Exhibit 99.1.

The information contained in this Item 2.02 and in Exhibit 99.1 shall be deemed to be “furnished” and shall not be deemed to be “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 or Sections 11 and 12(a)(2) of the Securities Act of 1933, as amended (the “Securities Act”). The information contained in this Item 2.02 and in Exhibit 99.1 shall not be incorporated by reference into any filing under the Securities Act or the Exchange Act made by the Company, whether made before or after the date hereof, regardless of any general incorporation language in such filing, except as shall be expressly set forth by specific reference in such filing.

Item 9.01 Financial Statements and Exhibits

Exhibit No.	Description
99.1	Press Release dated March 23, 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, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

Date: March 23, 2026	TALPHERA, INC.
	By:	/s/ Raffi Asadorian
		Raffi Asadorian
		Chief Financial Officer

Exhibit 99.1

Talphera Announces Fourth Quarter and Full Year 2025 Financial Results and Provides Corporate Update

Previously announced achievement of 50% enrollment of the NEPHRO CRRT clinical study in

March 2026 and closed the associated financing tranche of $4.1 million

All 12 clinical study sites now able to enroll patients to support an expected study completion in 2026

Cash and investments of $20.4 million at December 31, 2025

Virtual investor and analyst day with business updates to be held on Monday, March 23, 2026 at 11:00 am ET

SAN MATEO, Calif., March 23, 2026 – Talphera, Inc. (Nasdaq: TLPH), (“Talphera”), a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for use in medically supervised settings, today announced fourth quarter and full year 2025 financial results and provided a corporate update.

“Earlier this month, we communicated reaching the 35-patient enrollment mark in the 70-patient nafamostat registrational study for CRRT. Since then, we have added two more target profile clinical sites, and are continuing to enroll patients at a pace to enable completion of the study later this year,” stated Vince Angotti, CEO of Talphera. “Our target profile clinical sites and principal investigators remain highly motivated, driving over 90% of enrollment to date, and they are excited by the prospect of having nafamostat potentially approved for use during CRRT, given their dissatisfaction with the current anticoagulants currently being used for CRRT. Later today, we are hosting a live virtual investor and analyst webcast where you will hear directly from two principal investigators in the NEPHRO CRRT registrational study and their experiences with CRRT, the currently available anticoagulants for CRRT, and how they see nafamostat potentially filling an unmet need.”

Fourth Quarter 2025 and Recent Highlights

● Reached the 35-patient enrollment milestone or 50% enrollment in the NEPHRO CRRT study.

● All 12 clinical sites are now able to enroll patients and are expected to support increased enrollment rates for the remainder of the NEPHRO CRRT clinical study.

● Closed $4.1 million third tranche of the March 2025 private placement financing upon achieving the 35-patient enrollment milestone and other conditions.

● In October 2025, certain purchasers waived the conditions of the securities purchase agreement dated March 31, 2025, to effect both the second and third closings of the private placement with respect to such purchasers only, resulting in aggregate gross proceeds to Talphera of approximately $1.6 million.

Fourth Quarter 2025 Financial Information

● The cash and investments balance was $20.4 million as of December 31, 2025.

● Combined R&D and SG&A expenses for the fourth quarter of 2025 totaled $3.5 million compared to $3.0 million for the fourth quarter of 2024. Excluding non-cash stock-based compensation expense, these amounts were $3.3 million for the fourth quarter of 2025, compared to $2.8 million for the fourth quarter of 2024. The increase in combined R&D and SG&A expenses in the fourth quarter of 2025 was primarily due to increases in costs associated with Niyad development and certain G&A expenses.

● Net loss attributable to common shareholders for the fourth quarter of 2025 was $3.8 million, or $0.06 per basic and diluted share, compared to a net loss of $1.9 million, or $0.07 per basic and diluted share, for the fourth quarter of 2024.

2026 Guidance

● Cash operating expenses, or selling, general and administrative, and research and development expenses, excluding stock-based compensation, are expected to be in the range of $17 million to $18 million in 2026, which includes the expenses related to finalizing the NEPHRO CRRT registration trial later this year. This is an increase from approximately $13 million in 2025, which is driven by the NEPHRO CRRT study and related CMC expenses and validation batches expected to be incurred prior to the filing of a Premarket Approval (PMA) with the FDA.

Virtual Investor and Analyst Day Information

Talphera will hold a Virtual Investor and Analyst Day webcast at 11:00 a.m. Eastern Time/8:00 a.m. Pacific Time today to provide a business update and hear two principal investigators in the NEPHRO CRRT study provide their experiences with CRRT, the current anticoagulants being used during CRRT today and how they see nafamostat filling an unmet need in that market.

Investors and analysts who wish to participate in the webcast should register here or by visiting the Investors section of the Company's website at www.talphera.com and clicking on the webcast link posted within Investors/News & Events/Upcoming Events section.

About Talphera, Inc.

Talphera, Inc. is a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for use in medically supervised settings. Talphera's lead product candidate, Niyad® is a lyophilized formulation of nafamostat and is currently being studied under an investigational device exemption (IDE) as an anticoagulant for the extracorporeal circuit, and has received Breakthrough Device Designation status from the U.S. Food and Drug Administration (FDA).

This release is intended for investors only. For additional information about Talphera, please visit www.talphera.com.

About Niyad and Nafamostat

Nafamostat is a broad spectrum, synthetic serine protease inhibitor with anticoagulant, anti-inflammatory and potential anti-viral activities. Niyad® is a lyophilized formulation of nafamostat and is currently being studied under an IDE, as an anticoagulant for the extracorporeal circuit, and has received Breakthrough Device Designation Status from the FDA. Talphera’s registrational study of Niyad is named the NEPHRO CRRT (Nafamostat Efficacy in Phase 3 Registrational Continuous Renal Replacement Therapy) study. An ICD-10 procedural code, XY0YX37, has been issued for the extracorporeal introduction of nafamostat. The ICD-10 code is a specific/billable code that can be used to indicate a procedure. LTX-608 is a proprietary nafamostat formulation for direct IV infusion that may be investigated and developed for the treatment of acute respiratory distress syndrome (ARDS), disseminated intravascular coagulation (DIC), acute pancreatitis or as an anti-viral treatment, amongst other potential targets.

About the NEPHRO CRRT Study

The NEPHRO CRRT Study, which has received central IRB approval, is designed as a prospective, double-blinded trial to be conducted at up to 14 U.S. hospital intensive care units. The study will enroll and evaluate 70 adult patients undergoing renal replacement therapy, who cannot tolerate heparin or are at risk for bleeding. The primary endpoint of the study is mean post-filter activated clotting time using Niyad versus placebo over the first 24 hours. Key secondary endpoints include the mean post-filter activated clotting time over 72 hours, filter lifespan, number of filter changes over 72 hours, number of transfusions over 72 hours and dialysis efficacy (based on urea concentration) over the first 24 hours.

Forward-looking statements

This press release contains forward-looking statements based upon Talphera's current expectations and assumptions. These and any other forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking terminology such as “believe,” “expect,” “anticipate,” “may,” “if,” “intends,” “plans,” “potential,” ”projected,” “will,” or the negative of these words or other comparable terminology, and include: Talphera’s expectation that the two new high profile sites will support increased enrollment rates for an expected study completion later in 2026, that Talphera’s expected cash operating expenses will be in the $17 million to $18 million range for 2026. Talphera’s discussion of its strategy, plans and intentions also include forward-looking statements, which are predictions, projections and other statements about future events that are based on current expectations and assumptions. These forward-looking statements involve risks and uncertainties that could cause actual results to differ materially from those projected, anticipated or implied by such statements, including: (i) risks relating to Talphera's product development activities, including that clinical studies may not be fully enrolled or completed and/or confirm any safety, efficacy or other potential developmental product characteristics described or assumed in this press release; (ii) Talphera’s developmental product candidates may not be beneficial to patients or healthcare providers or be successfully commercialized; (iii) risks relating to Talphera’s ability to obtain regulatory approvals for its developmental product candidates; (iv) risks related to the ability of Talphera and its business partners to implement development plans, commercial launch plans, forecasts and other business expectations; and (v) risks related to Talphera's liquidity and its ability to maintain capital resources sufficient to conduct its clinical studies. Although it is not possible to predict or identify all such risks and uncertainties, they may include, but are not limited to, those described under the caption “Risk Factors” and elsewhere in Talphera's annual, quarterly and current reports (i.e., Form 10-K, Form 10-Q and Form 8-K) as filed or furnished with the SEC and any subsequent public filings. You are cautioned not to place undue reliance on any such forward-looking statements, which speak only as of the date such statements were first made. To the degree financial information is included in this press release, it is in summary form only and must be considered in the context of the full details provided in Talphera's most recent annual, quarterly or current report as filed or furnished with the SEC. Talphera's SEC reports are available at www.talphera.com under the “Investors” tab. Except to the extent required by law, Talphera undertakes no obligation to publicly release the result of any revisions to these forward-looking statements to reflect new information, events or circumstances after the date hereof, or to reflect the occurrence of unanticipated events.

Investor Contacts:

Talphera

Raffi Asadorian, CFO

650-216-3500

investors@talphera.com

LifeSci Advisors

Kevin Gardner

617-283-2856

kgardner@lifesciadvisors.com

### 

Selected Financial Data

(in thousands, except per share data)

(unaudited)

		Three Months Ended								Year Ended
		December 31								December 31
		2025				2024				2025				2024
Statement of Operations Data
Revenue		$	-			$	-			$	28			$	-
Operating costs and expenses:
Research and development (1)			1,561				1,323				6,033				6,718
Selling, general and administrative (1)			1,892				1,673				7,479				8,534
Total operating costs and expenses			3,453				2,996				13,512				15,252
Loss from operations			(3,453	)			(2,996	)			(13,484	)			(15,252	)
Other expense, net:
Interest income and other income, net			203				103				436				679
Gain on sale of future payments			-				-				-				1,246
(Loss) gain on change in fair value of warrant liability			(522	)			1,023				(1,315	)			717
Non-cash interest expense on liability related to sale of future payments			-				-				-				(394	)
Total other expense, net			(319	)			1,126				(879	)			2,248
Net loss from continuing operations			(3,772	)			(1,870	)			(14,363	)			(13,004	)
Net income from discontinued operations			-				-				73				-
Net loss		$	(3,772	)		$	(1,870	)		$	(14,290	)		$	(13,004	)
Net loss per share attributable to stockholders:
Basic and diluted, continuing operations		$	(0.06	)		$	(0.07	)		$	(0.34	)		$	(0.50	)
Basic and diluted, discontinued operations		$	-			$	-			$	0.00			$	-
Basic and diluted loss per share		$	(0.06	)		$	(0.07	)		$	(0.34	)		$	(0.50	)
Shares used in computing net loss per share of common stock, basic and diluted			66,954				26,238				42,411				25,846
(1) Includes the following non-cash stock-based compensation expense:
Research and development		$	57			$	91			$	246			$	375
Selling, general and administrative			128				139				453				614
Total		$	185			$	230			$	699			$	989

Selected Balance Sheet Data

(in thousands)

		December 31, 2025				December 31, 2024(1)
		(Unaudited)				(Unaudited)
Cash, cash equivalents and investments		$	20,381			$	8,863
Total assets			29,719				18,236
Total liabilities			12,684				10,235
Total stockholders' equity			17,035				8,001

⁽¹⁾ Derived from the audited financial statements as of that date included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2024.

Reconciliation of Non-GAAP Financial Measures

(Operating Expenses less stock-based compensation expense)

		Three Months Ended								Year Ended
		December 31								December 31
		(unaudited)								(unaudited)
		2025				2024				2025				2024
Operating expenses (GAAP):
Research and development		$	1,561			$	1,323			$	6,033			$	6,718
Selling, general and administrative			1,892				1,673				7,479				8,534
Total operating expenses			3,453				2,996				13,512				15,252
Less stock-based compensation expense			185				230				699				989
Operating expenses (non-GAAP)		$	3,268			$	2,766			$	12,813			$	14,263

FAQ

How did Talphera (TLPH) perform financially in Q4 2025?

Talphera reported no revenue and a net loss of $3.8 million in Q4 2025, compared with a $1.9 million net loss in Q4 2024. Operating expenses were $3.5 million, primarily research and development and selling, general and administrative costs supporting its clinical programs.

What were Talphera’s full year 2025 results?

For full year 2025, Talphera generated revenue of $28,000 and recorded a net loss of $14.3 million versus a $13.0 million net loss in 2024. Total operating expenses decreased to about $13.5 million, reflecting lower research and development and selling, general and administrative spending year over year.

How much cash did Talphera (TLPH) have at December 31, 2025?

At December 31, 2025, Talphera held $20.4 million in cash, cash equivalents and investments, up from $8.9 million a year earlier. Total assets were $29.7 million and stockholders’ equity was $17.0 million, providing resources to fund ongoing clinical development activities.

What progress has Talphera made in the NEPHRO CRRT study?

Talphera reached 50% enrollment in the 70-patient NEPHRO CRRT registrational study, enrolling 35 patients and activating all 12 clinical sites. The company expects study completion in 2026, supported by high-enrolling target profile sites and principal investigators engaged with Niyad’s potential role during CRRT.

What is Niyad and its regulatory status for Talphera (TLPH)?

Niyad is Talphera’s lead product candidate, a lyophilized formulation of nafamostat being studied under an investigational device exemption as an anticoagulant for the extracorporeal circuit. It has received Breakthrough Device Designation from the FDA, and an ICD-10 procedural code, XY0YX37, has been issued for nafamostat introduction.

What guidance did Talphera provide for 2026 expenses?

Talphera expects 2026 cash operating expenses to range between $17 million and $18 million. This guidance reflects planned spending on the NEPHRO CRRT registrational study, continued development of nafamostat-based programs, and general corporate costs as the company advances its pipeline.

Did Talphera announce any financing linked to its clinical milestones?

Yes. Talphera closed a financing tranche of $4.1 million after achieving 50% enrollment in the NEPHRO CRRT clinical study. This tranche, together with existing cash and investments, supports the company’s efforts to complete the trial and continue broader development of its nafamostat programs.

Filing Exhibits & Attachments

5 documents

Press Releases

• EX-99.1 EXHIBIT 99.1 152.3 KB

Other Documents

• EX-101 XBRL TAXONOMY EXTENSION SCHEMA 3.5 KB
• EX-101 XBRL TAXONOMY EXTENSION DEFINITION LINKBASE 11.5 KB
• EX-101 XBRL TAXONOMY EXTENSION LABEL LINKBASE 15.5 KB
• EX-101 XBRL TAXONOMY EXTENSION PRESENTATION LINKBASE 11.7 KB