Talphera Announces Second Quarter 2026 Financial Results and Provides Corporate Update

Rhea-AI Summary

Talphera (Nasdaq: TLPH) reported second quarter 2026 results and a corporate update on nafamostat. The NEPHRO CRRT registrational study of lead candidate Niyad reached 75% enrollment and is expected to complete this year, with all target clinical sites now activated.

Draft 2026 KDIGO acute kidney guidelines, after public comment, cited nafamostat as an acceptable CRRT anticoagulant, a change from prior recommendations. Updated market research estimates about 200,000 U.S. CRRT procedures in 2027, a 21% increase over Talphera’s prior estimate. The company regained Nasdaq $1 bid-price compliance.

For Q2 2026, cash and investments were $17.1 million. Combined R&D and SG&A expenses were $3.9 million, up from $3.7 million a year earlier. Net loss attributable to common shareholders was $4.3 million, or $0.06 per share, versus $3.5 million, or $0.10 per share, in Q2 2025.

Positive

• NEPHRO CRRT study 75% enrolled, expected to complete in 2026
• KDIGO 2026 guideline cites nafamostat as acceptable CRRT anticoagulant
• CRRT market estimate 200,000 U.S. procedures in 2027, +21% vs prior
• Nasdaq compliance regained with $1 bid price rule met
• Cash and investments $17.1 million at June 30, 2026
• Loss per share $0.06 vs $0.10 in Q2 2025

Negative

• Net loss from continuing operations $4.3 million vs $3.5 million YoY
• Total operating expenses $3.9 million vs $3.7 million in Q2 2025
• Cash, cash equivalents and investments down to $17.1 million from $20.4 million
• Shares outstanding 75.5 million vs 34.5 million, indicating dilution
• Total stockholders’ equity declined to $14.4 million from $17.0 million

Market Context

The earnings-tagged record averaged -5.55%, providing a company-specific benchmark for this 2Q26 rep...

Analysis

The earnings-tagged record averaged -5.55%, providing a company-specific benchmark for this 2Q26 report. The active S-3 is a resale registration, not company proceeds; operating expenses and enrollment progress are key items to monitor.

Key Figures

Study enrollment: 75% U.S. CRRT procedures: 200,000 procedures Procedure estimate increase: 21% +5 more

8 metrics

Study enrollment 75% NEPHRO CRRT clinical study

U.S. CRRT procedures 200,000 procedures 2027 annual estimate; 21% above prior estimate

Procedure estimate increase 21% 2027 U.S. CRRT procedures versus prior estimate

Cash and investments $17.1 million As of June 30, 2026

Combined R&D and SG&A $3.9 million Q2 2026 versus $3.7 million in Q2 2025

Net loss $4.3 million Q2 2026 versus $3.5 million in Q2 2025

Loss per share $0.06 Basic and diluted Q2 2026 versus $0.10 in Q2 2025

Study enrollment target 70 adult patients NEPHRO CRRT study design

Previous Earnings Reports

5 past events · Latest: May 13 (Neutral)

Same Type Pattern 5 events

Date	Event	Sentiment	24h Move	Catalyst
May 13	Q1 earnings report	Neutral	-0.4%	Enrollment progress and financing tranche accompanied Q1 results; price reaction was negative.
Mar 23	Full-year earnings	Negative	-3.8%	Financing tranche, enrollment progress, and cash update accompanied annual results; shares declined.
Nov 12	Q3 earnings report	Negative	-18.6%	Private placement, reduced expense guidance, and delayed study timing accompanied results; shares fell.
Aug 14	Q2 earnings report	Positive	-1.0%	Financing and improved loss metrics accompanied study update; shares declined despite positive items.
May 14	Q1 earnings report	Positive	-3.9%	FDA patient reduction, financing, and improved loss accompanied results; shares declined.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Pattern Detected

All five tag-matched earnings events had negative 24-hour reactions, averaging -5.55%, despite mixed reported catalysts.

Key Terms

crrt, investigational device exemption, activated clotting time, breakthrough device designation, +1 more

5 terms

crrt medical

"acceptable regional anticoagulant during CRRT"

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.

investigational device exemption regulatory

"currently being studied under an investigational device exemption (IDE)"

An investigational device exemption (IDE) is a regulatory permission that allows a medical device maker to test an unapproved device in people so the device’s safety and effectiveness can be studied. For investors, an IDE matters because it marks a formal step toward regulatory approval—like getting a temporary test-drive permit—and influences clinical cost, timelines, and the likelihood a device will reach the market and generate revenue.

activated clotting time medical

"mean post-filter activated clotting time using Niyad versus placebo"

Activated clotting time is a laboratory measure of how long a blood sample takes to form a clot after a standardized trigger; clinicians use it to monitor and adjust blood-thinning treatment during surgeries and other procedures. Investors care because it directly affects the safety, dosing and market acceptance of anticoagulant drugs, diagnostic tests and procedural devices—like a speedometer that helps doctors steer treatment and determine whether a product meets clinical and regulatory expectations.

breakthrough device designation regulatory

"received Breakthrough Device Designation status from the U.S. Food and Drug Administration"

A breakthrough device designation is a regulatory program that gives promising medical devices for serious or life‑threatening conditions priority support and faster review from a health authority (e.g., the U.S. FDA). Think of it as a “fast lane” or VIP pass through development and review: it can shorten time to market, lower regulatory uncertainty, and boost a company’s commercial prospects — but it is not an approval by itself.

serine protease inhibitor medical

"a broad spectrum, synthetic serine protease inhibitor"

A serine protease inhibitor is a drug or molecule that blocks a type of enzyme—called a serine protease—that cuts other proteins as part of normal body processes like blood clotting, digestion, immune response or viral replication. Investors care because these inhibitors can be developed into medicines that alter disease pathways; their success affects a company’s clinical progress, regulatory risk and potential market value much like a key that can lock an important biological ‘scissor’ from doing damage or causing disease.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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NEPHRO CRRT clinical study of nafamostat is 75% enrolled; expected to be complete this year

Draft 2026 KDIGO guidelines added nafamostat as an acceptable CRRT anticoagulant, a positive change from previous guidelines

Updated market research indicates an estimated 200,000 annual U.S. CRRT procedures, a 21% increase over prior estimates; investor event planned as enrollment nears completion

Cash and investments of $17.1 million at June 30, 2026

Conference call and webcast to be held on Wednesday August 12, 2026 at 4:30 pm ET

SAN MATEO, Calif., Aug. 12, 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 financial results for the second quarter of 2026 and provided a corporate update on the development of nafamostat.

"Reaching 75% enrollment in the NEPHRO CRRT study keeps us on track for completion by year-end," stated Vince Angotti, CEO of Talphera. "Site realignment is complete, with all target clinical sites now activated. We are particularly pleased with the high level of engagement from our principal investigators and study site personnel."

"In addition, the evolving treatment landscape continues to reinforce the potential role for nafamostat in CRRT. The KDIGO 2026 Clinical Practice Guideline for Acute Kidney Injury (AKI) and Acute Kidney Disease (AKD) is currently pending final publication following the close of its public comment period in May. The guideline references nafamostat as an acceptable regional anticoagulant during CRRT. This is a positive change from KDIGO's last published AKI guidelines," continued Mr. Angotti. "Separately, our updated market research on CRRT treatment patterns indicates that approximately 200,000 CRRT procedures will be performed in 2027 in the U.S., an increase of 21% over our prior estimate. As we near completion of enrollment, we look forward to hosting an investor event to share these findings and discuss the commercial opportunity for nafamostat, if approved, including the potential favorable implications of the evolving KDIGO guidelines."

Second Quarter 2026 and Recent Highlights

• 75% enrollment in the NEPHRO CRRT clinical study which is expected to be completed this year.
• Completed our clinical site realignment, with all target clinical sites now activated.
• KDIGO published its 2026 guideline and completed a public comment period, citing nafamostat as an acceptable CRRT anticoagulation alternative, a positive change from the last published recommendations. KDIGO (Kidney Disease: Improving Global Outcomes) is the global non-profit organization developing and implementing evidence-based clinical practice guidelines in kidney disease.
• Completed updated market research indicating approximately 200,000 annual U.S. CRRT procedures in 2027, a 21% increase over prior estimates.
• Regained Nasdaq compliance with the $1 bid price rule.

Second Quarter 2026 Financial Information

• The cash and investments balance was $17.1 million as of June 30, 2026.
• Combined R&D and SG&A expenses for the second quarter of 2026 totaled $3.9 million compared to $3.7 million for the second quarter of 2025. Excluding non-cash stock-based compensation expense, these amounts were $3.7 million for the second quarter of 2026, compared to $3.5 million for the second quarter of 2025. The increase in combined R&D and SG&A expenses in the second quarter of 2026 was primarily due to higher Niyad development expenses, reflecting increased enrollment.
• Net loss attributable to common shareholders for the second quarter of 2026 was $4.3 million, or $0.06 per basic and diluted share, compared to a net loss of $3.5 million, or $0.10 per basic and diluted share, for the second quarter of 2025.

Conference Call and Webcast

Talphera will hold a conference call and webcast at 4:30 p.m. Eastern Time/1:30 p.m. Pacific Time today to discuss the results and provide an update on the Company's business. 

Conference Call and Webcast Information

• Date: Wednesday, August 12, 2026 at 4:30 PM ET/1:30 PM PT
• Participant Dial-in (North America): 1-800-836-8184
• Participant Dial-in (International): 1-646-357-8785
• Conference ID: 50873
• Webcast Access: Click here 

The event can also be accessed in the Upcoming Events page in the Investors section of the Talphera website at www.talphera.com.

A replay of the webcast will be available on the Talphera website for 90 days after the event.

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 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 the NEPHRO CRRT clinical study will be completed later this year, Talphera's belief that the KDIGO 2026 Clinical Practice Guideline for Acute Kidney Injury (AKI) and Acute Kidney Disease (AKD) has potential favorable implications for the commercial opportunity for nafamostat, Talphera's updated market research on CRRT treatment patterns and its favorable impact on the market opportunity for nafamostat, and Talphera's belief that nafamostat will fill an unmet need in the market as a regional anticoagulant for CRRT.  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				Six Months Ended
	June 30				June 30
	2026		2025		2026		2025
Statement of Operations Data
Revenue	$                  -		$                      -		$          -		$       27
Operating costs and expenses:
Research and development (1)	1,690		1,500		3,340		2,669
Selling, general and administrative (1)	2,234		2,193		4,532		3,967
Total operating costs and expenses	3,924		3,693		7,872		6,636
Loss from operations	(3,924)		(3,693)		(7,872)		(6,609)
Other (expense) income, net:
Interest income and other income, net	172		83		341		152
(Loss) gain on change in fair value of warrant liability	(560)		121		663		302
Total other (expense) income, net	(388)		204		1,004		454
Net loss from continuing operations	(4,312)		(3,489)		(6,868)		(6,155)
Net income from discontinued operations	-		-		-		73
Net loss	$         (4,312)		$             (3,489)		$ (6,868)		$ (6,082)
Net loss per share attributable to stockholders:
Basic and diluted, continuing operations	$           (0.06)		$               (0.10)		$   (0.09)		$   (0.20)
Basic and diluted, discontinued operations	$                  -		$                      -		$          -		$          -
Basic and diluted loss per share	$           (0.06)		$               (0.10)		$   (0.09)		$   (0.20)
Shares used in computing net loss per share of common stock, basic and diluted	75,527		34,530		72,690		30,422
(1)   Includes the following non-cash stock-based compensation expense:
Research and development	$               71		$                   55		$     135		$     132
Selling, general and administrative	172		111		322		230
Total	$             243		$                 166		$     457		$     362

 

Selected Balance Sheet Data
(in thousands)
	June 30, 2026		December 31, 2025(1)
	(Unaudited)		(Unaudited)
Cash, cash equivalents and investments	$        17,076		$             20,381
Total assets	26,806		29,719
Total liabilities	12,400		12,684
Total stockholders' equity	14,406		17,035

(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, 2025.

 

Reconciliation of Non-GAAP Financial Measures
(Operating Expenses less stock-based compensation expense)
	Three Months Ended				Six Months Ended
	June 30				June 30
	(in thousands)				(in thousands)
	(unaudited)				(unaudited)
	2026		2025		2026		2025
Operating expenses (GAAP):
Research and development	$ 1,690		$ 1,500		$ 3,340		$ 2,669
Selling, general and administrative	2,234		2,193		4,532		3,967
Total operating expenses	3,924		3,693		7,872		6,636
Less stock-based compensation expense	243		166		457		362
Operating expenses (non-GAAP)	$ 3,681		$ 3,527		$ 7,415		$ 6,274

 

 

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SOURCE Talphera, Inc.

FAQ

How did Talphera (TLPH) perform financially in Q2 2026?

Talphera reported a Q2 2026 net loss of $4.3 million, or $0.06 per share. According to Talphera, operating expenses were $3.9 million, slightly higher than $3.7 million a year earlier, with no reported revenue in the quarter.

What is the cash position of Talphera (TLPH) as of June 30, 2026?

Talphera reported $17.1 million in cash, cash equivalents and investments as of June 30, 2026. According to Talphera, this compares with $20.4 million at December 31, 2025, reflecting cash usage to fund research, development and operating activities.

What progress did Talphera report on the NEPHRO CRRT nafamostat study in Q2 2026?

Talphera reported that the NEPHRO CRRT study reached 75% enrollment and is expected to complete in 2026. According to Talphera, clinical site realignment is finished, all target sites are activated, and the trial will evaluate 70 adult CRRT patients at up to 14 U.S. ICUs.

How do the 2026 KDIGO guidelines affect Talphera’s nafamostat program?

Draft 2026 KDIGO guidelines cite nafamostat as an acceptable regional anticoagulant for CRRT. According to Talphera, this represents a positive change versus previous KDIGO AKI recommendations and may support the potential clinical and commercial positioning of Niyad, if approved.

What CRRT market size did Talphera (TLPH) highlight for nafamostat in the U.S.?

Talphera’s updated research estimates about 200,000 CRRT procedures in the U.S. in 2027. According to Talphera, this is a 21% increase over its prior estimate and will be discussed at a planned investor event as NEPHRO CRRT enrollment nears completion.

Did Talphera regain Nasdaq listing compliance in 2026 and what was the issue?

Talphera reported it has regained Nasdaq compliance with the $1 bid price rule. According to Talphera, the company is now again in good standing with this specific Nasdaq requirement, which relates to maintaining a minimum bid price for its common stock.

What are Niyad and nafamostat in Talphera’s development pipeline?

Niyad is Talphera’s lead nafamostat-based anticoagulant for CRRT, under an FDA IDE with Breakthrough Device status. According to Talphera, nafamostat is a synthetic serine protease inhibitor with anticoagulant and anti-inflammatory activity, also formulated as LTX-608 for potential IV indications.