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

Rhea-AI Summary

Talphera (Nasdaq: TLPH) reported Q4 and full‑year 2025 results and a corporate update on March 23, 2026. Key items: 50% enrollment (35 of 70) in the NEPHRO CRRT registrational study, closing of a $4.1M financing tranche, and $20.4M cash and investments at December 31, 2025.

Q4 combined R&D and SG&A were $3.5M, net loss attributable to common shareholders was $3.8M (or $0.06 per share). 2026 cash operating expenses are guided to $17–18M. A virtual investor day was held March 23, 2026.

Positive

• NEPHRO CRRT enrollment at 35 of 70 patients (50%)
• Closed $4.1M third tranche of private placement financing
• Cash and investments of $20.4M at December 31, 2025
• All 12 clinical sites now able to enroll patients

Negative

• Q4 net loss widened to $3.8M from $1.9M
• Combined Q4 R&D and SG&A increased to $3.5M
• 2026 operating expense guidance up to $17–18M from ~$13M

News Market Reaction – TLPH

-3.81%

10 alerts

-3.81% News Effect

-16.2% Trough in 6 hr 17 min

-$2M Valuation Impact

$39M Market Cap

0.7x Rel. Volume

On the day this news was published, TLPH declined 3.81%, reflecting a moderate negative market reaction. Argus tracked a trough of -16.2% from its starting point during tracking. Our momentum scanner triggered 10 alerts that day, indicating notable trading interest and price volatility. This price movement removed approximately $2M from the company's valuation, bringing the market cap to $39M at that time.

Data tracked by StockTitan Argus on the day of publication.

Key Figures

Cash & investments: $20.4 million Q4 2025 R&D+SG&A: $3.5 million Q4 2025 net loss: $3.8 million ($0.06/share) +5 more

8 metrics

Cash & investments $20.4 million Balance at December 31, 2025

Q4 2025 R&D+SG&A $3.5 million Combined R&D and SG&A vs $3.0M in Q4 2024

Q4 2025 net loss $3.8 million ($0.06/share) Net loss vs $1.9M ($0.07/share) in Q4 2024

2026 cash opex guidance $17–18 million 2026 SG&A and R&D, ex stock-based comp; up from ~$13M in 2025

Private placement tranche $4.1 million Third tranche closed upon 35-patient enrollment milestone

Additional proceeds Approximately $1.6 million Second and third closings waivers in October 2025

Study enrollment 35 of 70 patients (50%) NEPHRO CRRT registrational study milestone

Active clinical sites 12 sites All clinical sites now able to enroll patients

Market Reality Check

Price: $0.8012 Vol: Volume 361,059 is 1.37x t...

normal vol

$0.8012 Last Close

Volume Volume 361,059 is 1.37x the 20-day average of 262,927, showing elevated interest ahead of the earnings update. normal

Technical Shares at 0.8329 are trading slightly below the 200-day MA of 0.86, despite today’s earnings and trial update.

Peers on Argus

TLPH was up about 3% while sector peers showed mixed moves, with some modest gai...

TLPH was up about 3% while sector peers showed mixed moves, with some modest gains and at least one decliner, and no peers flagged in the momentum scanner. This points to a stock-specific reaction to the earnings and NEPHRO CRRT updates rather than a broad sector rotation.

Previous Earnings Reports

5 past events · Latest: Nov 12 (Positive)

Same Type Pattern 5 events

Date	Event	Sentiment	Move	Catalyst
Nov 12	Q3 2025 earnings	Positive	-18.6%	Reported Q3 2025 results, cash of $21.3M, and sizable private placement.
Aug 14	Q2 2025 earnings	Positive	-1.0%	Q2 2025 results, NEPHRO enrollment at 15 patients, improved losses and lower opex.
May 14	Q1 2025 earnings	Positive	-3.9%	Q1 2025 results, FDA-approved NEPHRO size reduction and new financing facility.
Mar 31	FY 2024 earnings	Positive	+7.1%	Q4/FY 2024 results, NEPHRO patient reduction approval and $14.8M financing access.
Nov 13	Q3 2024 earnings	Negative	-25.6%	Q3 2024 results with higher net loss and increased R&D and SG&A expenses.

Pattern Detected

Recent earnings releases often highlighted NEPHRO CRRT progress and financing but saw mostly negative next-day moves, with an average around -8.41%. Today’s pre-announcement strength contrasts with that pattern and comes as cash has risen from $8.9M (Dec 2024) to $20.4M (Dec 2025) alongside advancing enrollment.

Recent Company History

Over the last five earnings-related updates since Nov 2024, Talphera has steadily advanced the NEPHRO CRRT program while shoring up its balance sheet. The FDA-approved reduction of trial size from 166 to 70 patients and multiple private placements (up to $14.8M and later a $29.0M facility) supported progress. Cash moved from $8.9M at Dec 31, 2024 to $21.3M at Sep 30, 2025. Today’s update continues this trajectory with $20.4M at year-end 2025 and 50% enrollment in NEPHRO CRRT.

Historical Comparison

-8.4% avg move · Past five earnings releases saw an average move of -8.41%, often despite operational progress, frami...

earnings

-8.4%

Average Historical Move earnings

Past five earnings releases saw an average move of -8.41%, often despite operational progress, framing today’s update against a history of cautious market reactions.

Earnings updates since late 2024 show a consistent narrative: FDA approval to shrink NEPHRO CRRT from 166 to 70 patients, growing enrollment (from 15 to 35 of 70 by March 2026), and repeated financings of up to $14.8M and $29.0M. Cash climbed from $8.9M at year-end 2024 to over $20M by year-end 2025, supporting completion of the registrational study.

Regulatory & Risk Context

Active S-3 Shelf

Shelf Active

Active S-3 Shelf Registration 2025-10-28

An active S-3 resale registration filed on Oct 28, 2025 covers up to 1,023,890 existing common shares and 1,706,484 shares from pre-funded warrants. Talphera itself is not selling securities and receives no proceeds from these sales, though it bears registration costs. This structure enables existing holders to sell into the market without expanding the company’s direct capital-raising capacity under this filing.

Market Pulse Summary

This announcement combines a standard earnings update with meaningful NEPHRO CRRT milestones. Talphe...

Analysis

This announcement combines a standard earnings update with meaningful NEPHRO CRRT milestones. Talphera reported $20.4M in cash and investments at year-end 2025, 50% enrollment in the 70-patient registrational study, and closure of a $4.1M financing tranche. Offsetting this, Q4 2025 net loss widened to $3.8M and 2026 cash operating expenses are guided to $17–18M. Investors may watch enrollment pace, cash usage versus guidance, and regulatory steps toward PMA filing.

Key Terms

crrt, nafamostat, private placement financing, stock-based compensation, +2 more

6 terms

crrt medical

"nafamostat potentially approved for use during CRRT, given their dissatisfaction"

Continuous Renal Replacement Therapy (CRRT) is a hospital treatment that uses a machine to slowly and continuously filter a patient’s blood when the kidneys have failed, similar to a home water filter running all day instead of a quick rinse. For investors, CRRT signals demand for critical-care equipment, supplies and specialized staffing, and changes in its use or reimbursement can affect revenues and costs for medical-device makers, hospitals and dialysis service providers.

nafamostat medical

"they see nafamostat potentially filling an unmet need"

Nafamostat is a short-acting prescription medication that blocks specific enzymes involved in blood clotting and inflammation, and has been studied as an antiviral in hospital settings. For investors it matters because its value depends on clinical trial results, regulatory approvals, and hospital adoption—think of it as a specialized tool whose commercial success rests on proving effectiveness and safety against competing treatments and standards of care.

private placement financing financial

"Closed $4.1 million third tranche of the March 2025 private placement financing"

Private placement financing is when a company raises money by selling stocks, bonds or other securities directly to a small group of chosen investors instead of offering them on the public market. For investors it matters because these deals can change ownership stakes, bring fresh cash for growth or debt reduction, and affect how easy it is to buy or sell those securities later—think of it like inviting a few private backers into a business rather than opening the door to the whole neighborhood.

stock-based compensation financial

"Excluding non-cash stock-based compensation expense, these amounts were $3.3 million"

Stock-based compensation is when a company pays employees, directors or consultants with shares or the right to buy shares instead of or in addition to cash. It matters to investors because issuing stock or options spreads ownership thinner (like cutting a pie into more slices), which can reduce each existing share’s claim on profits and can also change reported earnings; investors watch it to assess true cost of running the business and how management is incentivized.

premarket approval (pma) regulatory

"expected to be incurred prior to the filing of a Premarket Approval (PMA) with the FDA"

Premarket Approval (PMA) is the strict regulatory review process used by the U.S. authority for high-risk medical devices to prove they are safe and effective before they can be sold. For investors, a granted PMA is like receiving a key to a locked market: it can open exclusive sales opportunities, reduce near-term competition, and justify higher valuations, while also signaling that the company has cleared a costly, time-consuming hurdle.

fda regulatory

"prior to the filing of a Premarket Approval (PMA) with the FDA"

The FDA is the U.S. federal agency that evaluates and approves medical drugs, devices, biological therapies and certain foods; think of it as the gatekeeper that decides whether a medical product is safe and effective for patients. For investors, FDA decisions determine whether a company can sell a product, affect expected revenue and introduce regulatory risk, so approvals, rejections or safety warnings can quickly move a company's valuation and stock price.

AI-generated analysis. Not financial advice.

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 /PRNewswire/ -- 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.

 

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

 

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SOURCE Talphera, Inc.

FAQ

What is the NEPHRO CRRT enrollment update for Talphera (TLPH) as of March 23, 2026?

Talphera reported 50% enrollment (35 of 70 patients) in the NEPHRO CRRT registrational study. According to the company, all 12 clinical sites are active, supporting accelerated enrollment toward expected study completion in 2026.

How much financing did Talphera (TLPH) close related to NEPHRO CRRT enrollment?

Talphera closed a $4.1 million third tranche of its March 2025 private placement financing. According to the company, closing occurred upon achieving the 35‑patient enrollment milestone and satisfying agreed closing conditions.

What was Talphera's cash position at December 31, 2025 and how might it impact operations?

Talphera held $20.4 million in cash and investments at December 31, 2025. According to the company, these funds support ongoing NEPHRO CRRT activities and near‑term development expenses while additional financing and milestones progress.

What were Talphera's Q4 2025 expenses and net loss per share (TLPH)?

Combined R&D and SG&A for Q4 2025 were $3.5 million, with a net loss attributable to common shareholders of $3.8 million or $0.06 per share. According to the company, higher costs related to Niyad development contributed to the increase.

What guidance did Talphera (TLPH) give for 2026 operating expenses?

Talphera expects 2026 cash operating expenses of $17–18 million, excluding stock‑based compensation. According to the company, the increase from ~ $13 million in 2025 is driven by the NEPHRO CRRT trial, CMC work, and validation batches ahead of a PMA filing.