TALPHERA, INC.
TLPH evidence brief
What we can confirm
What it means
What to watch
Prepared research question
What matters most for TLPH—catalysts, financial risk and supporting evidence?
Traceable citations · Unknowns marked
BioSniper AI · TLPH
Talphera, Inc. is a biopharmaceutical company developing nafamostat-based product candidates, including Niyad for regional anticoagulation in hemodialysis and LTX-608 for acute indications, with a going concern warning and limited cash runway.
Key risk: Going concern risk
BioSniper Score
Based on 5 of 6 signals
Financial data as of Jun 30, 2026.
Tracking 2 pipeline candidates · 1 clinical trial for TALPHERA, INC..
Talphera, Inc. is a biopharmaceutical company developing nafamostat-based product candidates, including Niyad for regional anticoagulation in hemodialysis and LTX-608 for acute indications, with a going concern warning and limited cash runway.
- Talphera is developing Niyad, a nafamostat-based regional anticoagulant for the dialysis circuit in chronic kidney disease patients undergoing intermittent hemodialysis [sec_mda · as of 2025-11-12].
- The company also acquired LTX-608, a nafamostat formulation for direct IV infusion, intended for ARDS, DIC, acute pancreatitis, or as an anti-viral agent [sec_mda · as of 2025-11-12].
- As of June 30, 2026, Talphera reported cash & equivalents of $0.7M, no revenue, a net loss of $4.3M, and shareholders' equity of $17.0M [sec].
- Management expects to need additional capital to fund planned operations for at least the next twelve months and has expressed substantial doubt about the company's ability to continue as a going concern [sec_mda · as of 2026-08-12].
- The company's ability to complete its clinical trial for Niyad and develop other nafamostat candidates is a key factor affecting future capital requirements [sec_mda · as of 2026-08-12].
What works
- Talphera's product candidates are based on nafamostat, a molecule with known anticoagulant, anti-inflammatory, and potential anti-viral activities, providing a well-understood mechanism [sec_mda · as of 2025-11-12].
- The company has identified multiple potential indications for its nafamostat formulations, including Niyad for hemodialysis and LTX-608 for acute conditions, diversifying its pipeline [sec_mda · as of 2025-11-12].
What to weigh
- Talphera has a very limited cash position of $0.7M as of June 30, 2026, and expects to need additional capital to fund operations for the next twelve months [sec; sec_mda · as of 2026-08-12].
- The company has expressed substantial doubt about its ability to continue as a going concern, and its plans to raise additional funds are not entirely in place [sec_mda · as of 2026-08-12].
- Talphera has no approved products and no revenue, with a net loss of $4.3M in the latest quarter, indicating a high cash burn rate [sec].
- The company faces risks related to patient enrollment delays, serious adverse effects, and the need to obtain regulatory approvals for its product candidates [sec_mda · as of 2026-03-23].
From the filings
Quoted directly from source documents.
Talphera expects to need additional capital to fund operations for at least the next twelve months.
“Considering our current cash resources and current and expected levels of operating expenses for the next twelve months, we expect to need additional capital to fund our planned operations for at least the next twelve months.”
SEC MD&A · August 12, 2026
There is substantial doubt about the company's ability to continue as a going concern.
“There is substantial doubt regarding our ability to continue as a going concern.”
SEC MD&A · March 23, 2026
Niyad is intended as a regional anticoagulant for the dialysis circuit in chronic kidney disease patients.
“The second intended indication for Niyad is as a regional anticoagulant for the dialysis circuit for chronic kidney disease patients undergoing intermittent hemodialysis in dialysis centers.”
SEC MD&A · November 12, 2025
Talphera acquired LTX-608 for development in acute indications.
“the Company acquired LTX-608, a nafamostat formulation for direct IV infusion, that it intends to develop for the treatment of one or more of the following indications: ARDS, DIC, acute pancreatitis or as an anti-viral agent.”
SEC MD&A · November 12, 2025
Risks & what to watch (4)›
Key risks
- Going concern risk — Substantial doubt about ability to continue as a going concern; needs additional capital soon [sec_mda · as of 2026-08-12].
- Cash runway insufficient — Only $0.7M cash as of June 30, 2026, with no revenue and ongoing losses [sec].
- Clinical trial delays — Risk of delays or difficulties in enrolling patients for Niyad trial [sec_mda · as of 2026-03-23].
- Regulatory approval uncertainty — No approved products; all candidates require FDA or other regulatory approvals [sec_mda · as of 2026-03-23].
What to watch
- Ability to raise additional capital through equity offerings, debt, or partnerships to extend cash runway [sec_mda · as of 2026-08-12].
- Progress and enrollment in the clinical trial for Niyad, the lead product candidate [sec_mda · as of 2026-08-12].
- Development updates for LTX-608 and other nafamostat formulations [sec_mda · as of 2025-11-12].
- Any regulatory submissions or interactions with the FDA regarding Niyad or LTX-608 [sec_mda · as of 2026-08-12].
Sources: SEC MD&A · Generated August 13, 2026 · How we verify sources →
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Evidence & data
Score breakdownBased on 5 of 6 signals · derived from public data
12.6 months
D/E 0.86
Lead: Phase 3
2 candidates
No upcoming catalysts tracked
1 buy · 0 sells (180d)
Runway
Pipeline
Regulatory
Financials
Institutional Holdings
Source: SEC Form 13F · as of Mar 2026Institutional holders
39
Total value held
$5.9M
| Holder | Shares | Value |
|---|---|---|
| rock springs capital management lp | 3,589,186 | $2.7M |
| cantor fitzgerald, l. p. | 887,481 | $663K |
| vanguard capital management llc | 883,222 | $660K |
| dauntless investment group, llc | 435,234 | $325K |
| geode capital management, llc | 419,980 | $314K |
| shay capital llc | 250,083 | $187K |
| renaissance technologies llc | 237,755 | $178K |
| citadel advisors llc | 216,451 | $162K |
| vanguard fiduciary trust co | 192,405 | $144K |
| diadema partners lp | 153,563 | $115K |
Showing top 10 of 39 institutional holders of TALPHERA, INC.. Open the full 13F history after sign-in.
Short Interest
as of May 22, 2026- % of float
- 2.5%
- Days to cover
- 7.5
- Shares short
- 1,039,297
- Daily short volume
- -
Short percent of float and days-to-cover reflect reported short positioning. Daily short volume is the exchange-reported short share of a single day's trading volume and is noisier. See the most-shorted biotech ranking →
TLPH short interestFrequently asked questions
What is the AI investment thesis for TALPHERA, INC.?
Talphera, Inc. is a biopharmaceutical company developing nafamostat-based product candidates, including Niyad for regional anticoagulation in hemodialysis and LTX-608 for acute indications, with a going concern warning and limited cash runway.
What is TALPHERA, INC.'s lead drug candidate?
TALPHERA, INC.'s most advanced tracked candidate is ltx-608 (Preclinical) for Antiviral treatment, or treatment of ARDS, DIC or acute pancreatitis.
Who is the CEO of TALPHERA, INC.?
Mr. Vincent J. Angotti is the chief executive officer of TALPHERA, INC. (TLPH).
Where is TALPHERA, INC. headquartered?
TALPHERA, INC. (TLPH) is headquartered in San Mateo, CA, United States.
What therapeutic areas does TALPHERA, INC. focus on?
TALPHERA, INC. develops therapies across Infectious Disease, Respiratory, Hematology, Nephrology, Gastroenterology.
The AI overview and BioSniper Score are neutral, data-derived signals built from public SEC filings, ClinicalTrials.gov and FDA records — not investment advice.