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TLPH

TALPHERA, INC.

Biopharma developer (SEC filing verified)·Phase 3·San Mateo, CA, United States·CEO: Mr. Vincent J. Angotti
Infectious DiseaseRespiratoryHematologyNephrologyGastroenterology

TLPH evidence brief

What we can confirm

BioSniper Score:
6.8 / 10
Market Cap:
$61.8M
Lead Asset:
ltx-608 (Preclinical)

What it means

The company data is ready for cross-source review; unsupported conclusions remain unknown.

What to watch

Market Cap: $61.8M · Lead Asset: ltx-608 (Preclinical)
BioSniper AIPage evidence connected

Prepared research question

What matters most for TLPH—catalysts, financial risk and supporting evidence?

Run cited research

Traceable citations · Unknowns marked

BioSniper AI · TLPH

Talphera, Inc. (TLPH) is a specialty pharmaceutical company developing Niyad, a regional anticoagulant for dialysis circuits, and LTX-608, a nafamostat formulation for IV infusion, with its resources currently focused on Niyad development [sec_mda · as of 2026-05-13].

Key risk: Cash runway

6.8/10

BioSniper Score

Based on 3 of 6 signals

Limited data coverage

Market Cap

$61.8M

Cash Runway

—

Lead Asset

ltx-608 (Preclinical)

Next Catalyst

—

Financial data as of Jun 30, 2026.

Tracking 2 pipeline candidates · 1 clinical trial for TALPHERA, INC..

AI OverviewAI overview is shown in English only.

Talphera, Inc. (TLPH) is a specialty pharmaceutical company developing Niyad, a regional anticoagulant for dialysis circuits, and LTX-608, a nafamostat formulation for IV infusion, with its resources currently focused on Niyad development [sec_mda · as of 2026-05-13].

  • Cash and equivalents were $0.7M as of 2026-06-30 [sec].
  • Total revenue was $0.0M as of 2026-06-30 [sec].
  • Net income was -$4.3M as of 2026-06-30 [sec].
  • Shareholders' equity was $14.4M as of 2026-06-30 [sec].
  • The NEPHRO-CRRT registrational study had reached 75% enrollment as of August 2026, with completion expected later in 2026 [news · published 2026-08-13].

What works

  • Talphera has a focused pipeline with Niyad, a regional anticoagulant for the dialysis circuit, and LTX-608 for multiple indications, targeting medically supervised settings [sec_mda · as of 2026-05-13].
  • The NEPHRO-CRRT study for Niyad is 75% enrolled and on track for completion in 2026, with a potential PMA filing in H1 2027 [news · published 2026-08-13].
  • Updated market research indicates 200,000 annual CRRT procedures, supporting potential demand for Niyad [news · published 2026-08-13].

What to weigh

  • Cash and equivalents were only $0.7M as of 2026-06-30, indicating a very limited cash runway [sec].
  • The company has no current revenue ($0.0M as of 2026-06-30) and a net loss of -$4.3M [sec].
  • SEC filings repeatedly state 'substantial doubt regarding our ability to continue as a going concern' and the need for additional financing [sec_mda · as of 2026-03-23].
  • The company faces risks including maintaining Nasdaq listing and managing cash burn [sec_mda · as of 2026-08-12].

From the filings

Quoted directly from source documents.

  • Cash and equivalents as of June 30, 2026

    “Cash and cash equivalents--End of period | | $ | 742”

    SEC MD&A · August 12, 2026

  • NEPHRO-CRRT study enrollment at 75%

    “reached 75% enrollment in its NEPHRO-CRRT registrational study”

    News · August 13, 2026

  • Going concern risk

    “There is substantial doubt regarding our ability to continue as a going concern.”

    SEC MD&A · March 23, 2026

  • Company focus on Niyad

    “All resources are currently focused on developing Niyad.”

    SEC MD&A · May 13, 2026

Risks & what to watch (4)›

Key risks

  • Cash runway — Cash of $0.7M as of 2026-06-30 is very low, raising going-concern risk [sec].
  • No revenue — Zero revenue as of 2026-06-30, with net loss of -$4.3M [sec].
  • Nasdaq listing risk — Ability to maintain Nasdaq listing is identified as a risk factor [sec_mda · as of 2026-08-12].
  • Clinical execution — Niyad PMA filing depends on completing NEPHRO-CRRT study and regulatory approval [news · published 2026-08-13].

What to watch

  • Completion of NEPHRO-CRRT enrollment later in 2026 [news · published 2026-08-13].
  • Potential Niyad PMA filing in H1 2027 [news · published 2026-08-13].
  • Ability to raise additional capital to address cash runway concerns [sec_mda · as of 2026-08-12].
  • Any updates on LTX-608 development or discontinuation decisions [sec_mda · as of 2026-05-13].

Sources: News · SEC MD&A · Generated October 10, 2026 · How we verify sources →

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Evidence & data

Score breakdownBased on 3 of 6 signals · derived from public data

Cash RunwayN/A

Cash runway data unavailable

Financial Health7.4

D/E 0.86

Pipeline Maturity8.5

Lead: Phase 3

Pipeline Breadth4.6

2 candidates

Catalyst MomentumN/A

No upcoming catalysts tracked

Insider SignalN/A

No insider transactions in the last 180 days

Pipeline

Regulatory

Financials

Institutional Holdings

Source: SEC Form 13F · as of Mar 2026

Institutional holders

45

Total value held

$16.2M

Showing top 10 of 45 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 interest

Governance

Frequently asked questions

What is the AI investment thesis for TALPHERA, INC.?

Talphera, Inc. (TLPH) is a specialty pharmaceutical company developing Niyad, a regional anticoagulant for dialysis circuits, and LTX-608, a nafamostat formulation for IV infusion, with its resources currently focused on Niyad development [sec_mda · as of 2026-05-13].

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.

923 companies304,844 SEC filings22,644 clinical trials100% citation-verification pass rate (7d)How we verify →

The AI overview and BioSniper Score are neutral, data-derived signals built from public SEC filings, ClinicalTrials.gov and FDA records — not investment advice.