Talphera, Inc.
- Open
- 1.21
- Day high
- 1.21
- Day low
- 1.20
- Prev close
- 1.19
- Volume
- 7K
- Mkt cap
- $63M
- P/E (TTM)
- —
- EPS (TTM)
- —
- P/B
- 4.4
- P/S
- —
- Yield
- —
- Per share
- —
Talphera, Inc. (TLPH) is a Healthcare company listed on NASDAQ. The stock is up 111% over the past year. Drillr has 1 published research article covering TLPH.
Talphera, Inc. (TLPH) financials & analyst ratings
Fundamentals (TTM)
Analyst consensus · 2 analysts
Source: exchange market data + company filings. Figures are trailing-twelve-month or as most recently reported. For informational purposes only — not investment advice.
TLPH earnings date, history & EPS estimates
| Report date | EPS est | EPS actual | Surprise | Revenue | Rev. surprise |
|---|---|---|---|---|---|
| Aug 12, 2026 | $-0.06 | $-0.06 | +4.0% | — | — |
| May 13, 2026 | $-0.07 | $-0.04 | +42.9% | — | — |
| Mar 23, 2026 | $-0.07 | $-0.06 | +20.0% | — | — |
| Nov 12, 2025 | $-0.07 | $-0.11 | -46.7% | $1000 | — |
| Aug 14, 2025 | $-0.12 | $-0.10 | +16.7% | — | — |
| Mar 31, 2025 | $-0.21 | $-0.07 | +66.7% | — | — |
| Aug 14, 2024 | $-0.22 | $-0.15 | +31.8% | — | — |
| Dec 6, 2023 | $-0.28 | $-0.08 | +71.4% | $281000 | — |
| Aug 10, 2023 | $-0.53 | $-0.41 | +22.6% | $253000 | +237.3% |
| Mar 30, 2019 | — | $-3.47 | — | $265000 | — |
TLPH insider trading activity (SEC Form 4)
| Date | Insider | Type | Shares | Price |
|---|---|---|---|---|
| Jun 24, 2026 | Bozilenko Marinadirector | Grant | 30,700 | $0.98 |
| Jun 24, 2026 | ADAMS ADRIANdirector | Grant | 30,700 | $0.98 |
| Jun 24, 2026 | ADAMS ADRIANdirector | Grant | 5,100 | — |
| Jun 24, 2026 | WAN MARK Adirector | Grant | 5,100 | — |
| Jun 24, 2026 | WAN MARK Adirector | Grant | 30,700 | $0.98 |
| Jun 24, 2026 | Todisco Josephdirector | Grant | 5,100 | — |
| Jun 24, 2026 | Todisco Josephdirector | Grant | 30,700 | $0.98 |
| Jun 24, 2026 | JAIN ABHINAVdirector | Grant | 5,100 | — |
| Jun 24, 2026 | JAIN ABHINAVdirector | Grant | 30,700 | $0.98 |
| Jun 24, 2026 | HOFFMAN STEPHEN Jdirector | Grant | 5,100 | — |
| Jun 24, 2026 | HOFFMAN STEPHEN Jdirector | Grant | 30,700 | $0.98 |
| Jun 24, 2026 | Broadfoot Jill Mariedirector | Grant | 5,100 | — |
| Jun 24, 2026 | Broadfoot Jill Mariedirector | Grant | 30,700 | $0.98 |
| Jun 24, 2026 | Bozilenko Marinadirector | Grant | 5,100 | — |
| May 21, 2026 | Aslam Shakilofficer: Chief Medical Officer | Tax | 4,518 | $0.82 |
Source: TLPH SEC Form 4 filings, latest Jun 24, 2026. For informational purposes only — not investment advice.
See the full TLPH insider & 13F page →Talphera, Inc. company profile
Overview
Talphera, Inc. (NASDAQ:TLPH) is a specialty pharmaceutical company founded in 2005 and headquartered in San Mateo, California. Originally incorporated as AcelRx Pharmaceuticals, the company rebranded to Talphera in January 2024 following a strategic transformation. The company went public in 2011 and has evolved from developing pain management solutions to focusing exclusively on therapies for medically supervised settings, particularly critical care environments. Talphera divested its primary commercial asset, DSUVIA (a pain medication), in 2023 to concentrate resources on developing nafamostat-based anticoagulation therapies for hospital intensive care units.
Business
Talphera operates in the specialty pharmaceutical industry, developing therapies specifically designed for use in hospitals and other medically supervised environments. The company's core focus is on critical care medicine, particularly addressing complications that arise in intensive care units (ICUs). The company's lead product candidate is Niyad, a lyophilized (freeze-dried) formulation of nafamostat mesylate. Nafamostat is an anticoagulant - a medication that prevents blood from clotting. Niyad is being developed specifically for use in Continuous Renal Replacement Therapy (CRRT), a life-support treatment used in ICUs for patients with severe kidney failure. CRRT works by continuously filtering a patient's blood outside their body through an artificial kidney machine, similar to dialysis but performed around the clock for critically ill patients. The challenge that Niyad addresses is significant: when blood circulates through external tubing and filters in CRRT machines, it naturally tends to clot, which can block the system and interrupt life-saving treatment. Currently, hospitals use anticoagulants like heparin or citrate to prevent this clotting, but these medications can cause serious side effects including bleeding complications or metabolic disturbances. Nafamostat has been used safely in Japan and South Korea for over 30 years and offers a potentially safer alternative with fewer systemic side effects. Beyond Niyad, Talphera has a smaller pipeline including LTX-608 (an anti-inflammatory compound being explored for COVID-19 and other inflammatory conditions), Fedsyra (a pre-filled ephedrine syringe for blood pressure support), and PFS-02 (a pre-filled phenylephrine syringe). However, these represent minimal revenue contributions, with Niyad comprising essentially 100% of the company's development focus and future revenue potential.
Revenue model
Talphera's business model is built around developing and commercializing specialty pharmaceuticals for hospital use, with revenue expected to come primarily from product sales to healthcare institutions. The company currently generates minimal revenue, with only $27,000 in Q1 2025, primarily from royalties on its divested DSUVIA product. The primary revenue opportunity lies in Niyad's potential commercial launch, estimated to reach peak sales of $100 million annually in the CRRT market alone, with additional potential in outpatient dialysis settings. The company's pricing strategy targets $47-49 per vial, with an estimated usage of 10 vials per day over 6 days of therapy per patient. The paying customers would be hospitals, particularly those with large ICUs that frequently use CRRT for critically ill patients with kidney failure. Several factors could significantly impact Talphera's margins and market success. Positive factors include the potential for Niyad to become the first FDA-approved regional anticoagulant specifically for CRRT, creating a significant competitive advantage. The drug's 30-year safety track record in international markets and FDA Breakthrough Device designation could accelerate adoption. Supply shortages of current anticoagulants like heparin and citrate could create additional market opportunities. The concentrated hospital market allows for focused sales efforts with high-value customers. Negative factors include the inherent conservatism of critical care physicians who may be reluctant to switch from established treatments, potential competition from existing generic anticoagulants, and the risk that clinical trials may not demonstrate sufficient superiority to justify adoption. Manufacturing and regulatory compliance costs for a specialized hospital product could pressure margins, while the limited patient population restricts overall market size compared to broader pharmaceutical markets.
Competitive moat
Talphera's competitive moat appears moderate but potentially strengthening, primarily built around regulatory exclusivity and specialized market knowledge rather than fundamental competitive advantages. The company's strongest moat element is its potential to become the first FDA-approved regional anticoagulant specifically designed for CRRT, which would provide significant regulatory barriers to entry and first-mover advantages in a specialized market. The FDA's Breakthrough Device designation for Niyad provides expedited regulatory pathways and signals regulatory support, creating temporary competitive protection. Additionally, nafamostat's 30-year international safety record provides clinical validation that competitors would need years to replicate with alternative compounds. The specialized nature of the CRRT market, requiring deep understanding of critical care nephrology and intensive care unit workflows, creates knowledge barriers that could deter larger pharmaceutical companies from entering this relatively small market. However, the moat faces significant vulnerabilities. The underlying compound, nafamostat mesylate, is not patent-protected as it has been used internationally for decades, meaning competitors could potentially develop their own formulations once Talphera demonstrates market viability. Existing anticoagulants like heparin and citrate are well-established, inexpensive, and familiar to physicians, creating switching costs and inertia that Niyad must overcome. Large pharmaceutical companies with greater resources could potentially enter the market if Talphera proves its commercial viability. The company's moat strength will ultimately depend on execution - successfully completing clinical trials, achieving FDA approval, and building strong relationships with nephrologists and intensivists. Without patent protection on the underlying molecule, Talphera's competitive advantage relies heavily on being first to market and establishing clinical adoption before competitors can respond.
Risks & safety
Talphera presents a high-risk investment profile with limited margin of safety, characteristic of a clinical-stage pharmaceutical company burning cash while developing its lead product candidate. **Cash and Solvency:** - Current cash position of $5.4 million as of Q1 2025 ($9.8 million pro forma after recent financing) - Quarterly cash burn of approximately $2.9 million in Q1 2025, down from $4.2 million in Q1 2024 - Expected annual cash operating expenses of $17-19 million for 2025 - Secured PIPE financing of up to $14.8 million in three tranches, providing runway into 2026 - Zero debt, eliminating solvency risk from leverage - Current ratio of 3.1x indicates strong short-term liquidity **Valuation Metrics:** - Market capitalization of approximately $10.5 million - Price-to-book ratio of 2.3x - Negative earnings and EBITDA make traditional valuation metrics inapplicable - Enterprise value significantly below estimated peak revenue potential of $100 million **Other Considerations:** - Single-asset risk with Niyad representing essentially all value - Clinical trial execution risk with ongoing NEPHRO study - Regulatory approval uncertainty despite Breakthrough Device designation - Limited diversification with minimal revenue from other sources
Recent development
Talphera has undergone significant strategic transformation over the past few years, fundamentally reshaping its business model and focus. The most significant change was the company's rebranding from AcelRx Pharmaceuticals to Talphera in January 2024, coinciding with the divestiture of its commercial pain management product DSUVIA to Alora Pharmaceuticals in April 2023. This strategic pivot allowed the company to reduce annual operating expenses by approximately $14 million while retaining royalty interests in DSUVIA sales. The company has concentrated its resources entirely on developing Niyad for CRRT anticoagulation, receiving FDA Investigational Device Exemption (IDE) approval in October 2023 to begin its registrational NEPHRO study. This 70-patient clinical trial (reduced from the original 166 patients after FDA approval) represents the company's path to potential FDA approval and commercialization. Key operational developments include significant leadership changes, with Dr. Shakil Aslam joining as Chief Development Officer in May 2024, bringing specialized nephrology expertise and industry relationships. Dr. Pam Palmer, the company's co-founder and Chief Medical Officer, retired in October 2024 but continues to advise on the NEPHRO study completion. The company has made substantial progress in clinical trial optimization, implementing automated patient identification systems, expanding from surgical ICUs to medical ICUs, and focusing on sites with nephrologists as principal investigators rather than surgeons. These changes have improved patient screening efficiency and enrollment potential. Financing activities have been crucial, with the company completing an $18 million equity raise from existing investors Nantahala Capital and Rosalind Advisors, plus an $8 million royalty monetization with Xoma Royalty. Most recently, the company secured a $14.8 million PIPE financing structured in three tranches tied to clinical milestones and stock price performance.
TLPH company profile · for informational purposes only — not investment advice.
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