Talphera (TLPH)
NASDAQ:TLPH
Want to see TLPH full AI Analyst Report?
Top Page
Talphera
(NASDAQ:TLPH)
Select Model
Select Model
Rating:51Neutral
Price Target:
$0.80
▼(-26.91% Downside)
Action:Reiterated
Date:05/14/26
The score is held down primarily by very weak fundamentals (minimal revenue, large losses, and ongoing cash burn). Offsetting factors include a currently low-leverage balance sheet and a generally positive earnings-call outlook on clinical milestones, while technicals show modest improvement. Valuation remains challenged due to negative earnings, and the Nasdaq bid-price notice adds a meaningful near-term risk.
Positive Factors
Low leverage / clean balance sheet
Zero reported debt and positive equity give Talphera structural financial flexibility to fund clinical execution or seek non-dilutive partners. Over 2–6 months this balance-sheet buffer reduces immediate solvency risk and supports the company through trial readouts and regulatory activities.
Negative Factors
Minimal revenue; large net loss
Virtually no operating revenue and a multi‑million net loss indicate Talphera is not yet a self-sustaining commercial business. Over several months this margin profile means continued reliance on external capital or milestone financing, and little current capacity to absorb unexpected development delays.
Read all positive and negative factors
Positive Factors
Negative Factors
Low leverage / clean balance sheet
Zero reported debt and positive equity give Talphera structural financial flexibility to fund clinical execution or seek non-dilutive partners. Over 2–6 months this balance-sheet buffer reduces immediate solvency risk and supports the company through trial readouts and regulatory activities.
Read all positive factors
Talphera (TLPH) vs. SPDR S&P 500 ETF (SPY)
Market Cap
$42.35M
Dividend YieldN/A
Average Volume (3M)2.97M
Price to Earnings (P/E)―
Beta (1Y)0.74
Revenue Growth-96.30%
EPS Growth32.21%
CountryUS
Employees13
SectorHealthcare
Sector Strength45
IndustryDrug Manufacturers - Specialty & Generic
Share Statistics
EPS (TTM)-0.33
Shares Outstanding51,899,647
10 Day Avg. Volume675,544
30 Day Avg. Volume2,969,035
Financial Highlights & Ratios
PEG Ratio0.11
Price to Book (P/B)2.84
Price to Sales (P/S)1726.72
P/FCF Ratio-4.25
Enterprise Value/Market Cap0.31
Enterprise Value/Revenue12.92K
Enterprise Value/Gross Profit12.92K
Enterprise Value/Ebitda-0.83
Forecast
1Y Price Target
$3.17Price Target Upside187.88% Upside
Rating ConsensusStrong Buy
Number of Analyst Covering3
EPS Forecast (FY)-0.28
Revenue Forecast (FY)N/A
Talphera Business Overview & Revenue Model
Company Description
Talphera, Inc., a specialty pharmaceutical company, focuses on the development and commercialization of therapies for use in medically supervised settings. Its lead product candidate is Niyad, a lyophilized formulation of nafamostat, which is unde...
How the Company Makes Money
null...
Talphera Earnings Call Summary
Earnings Call Date:May 13, 2026
(Q1-2026)
| % Change Since: |
Next Earnings Date:Aug 19, 2026
Earnings Call Sentiment Positive
The call conveyed strong clinical and operational momentum: enrollment has surpassed the 50% milestone, sites and KOLs reported favorable feedback on dosing simplicity and stability, and management expects a rapid top-line read in H2 2026 with a PMA plan for 2027. However, the company faces higher operating expenses and depends on two conditional financing tranches (~$16M) to fund the path to potential approval, with enrollment variability and financing contingency as primary risks. Overall, positive progress is balanced against execution and financing risk, but the highlights outweigh the lowlights.Positive Updates
Enrollment Progress & Milestones
Achieved the 50% enrollment milestone in early March 2026 and have since "well exceeded" 50%; company expects to complete enrollment in 2026 and to file a PMA for Niyad in 2027. 9 of 12 activated sites aligned with the new target profile and have enrolled over 90% of patients to date.
Negative Updates
Increase in Operating Expenses
Cash operating expenses (R&D + SG&A) for Q1 2026 were $3.9M vs $2.9M in Q1 2025, an increase of $1.0M (+34.5%). Excluding non-cash stock-based compensation, cash operating expenses were $3.7M vs $2.7M, an increase of $1.0M (+37.0%). Management attributed the increase to higher Niyad development costs (driven by increased enrollment) and higher G&A.
Read all updates
Q1-2026 Updates
Positive
Negative
Enrollment Progress & Milestones
Achieved the 50% enrollment milestone in early March 2026 and have since "well exceeded" 50%; company expects to complete enrollment in 2026 and to file a PMA for Niyad in 2027. 9 of 12 activated sites aligned with the new target profile and have enrolled over 90% of patients to date.
Read all positive updates
Company Guidance
Management guided that Talphera expects to complete enrollment in the NEPHRO CRRT study in 2026, will announce last‑patient‑out and then top‑line data within about one month (guiding to a second‑half‑2026 readout), and is targeting a PMA filing for Niyad in 2027; they do not plan interim enrollment updates prior to LPO. Key financial metrics: cash of $21.1M at March 31, 2026, a $4.1M tranche closed in Q1 (from the March 2025 placement) and two remaining conditional tranches totaling ≈$16M expected to close around the topline data, which management believes, together with cash on hand, funds the company through a potential PMA approval next year; Q1 cash operating expenses (R&D + SG&A) were $3.9M vs $2.9M in Q1 2025 (or $3.7M vs $2.7M excluding non‑cash stock‑based compensation). Clinical metrics cited include having well exceeded the 50% enrollment milestone, 9 of 12 activated sites aligned with the new target profile that have enrolled >90% of patients, up to 14 FDA‑granted sites with two additional sites to be added, a 24‑hour primary endpoint (72‑hour secondary), and pharmacodynamic results showing ~70% of patients reach target ACT at first dose, ~25% require one titration and a few require two, with all in range by the end of the first hour.Talphera Financial Statement Overview
Summary
Income Statement
12
Very Negative
Balance Sheet
58
Neutral
Cash Flow
18
Very Negative
| Breakdown | TTM | Dec 2025 | Mar 2025 | Dec 2023 | Dec 2022 | Dec 2021 |
|---|---|---|---|---|---|---|
Income Statement | ||||||
| Total Revenue | 1.00K | 28.00K | 0.00 | 651.00K | 0.00 | 378.00K |
| Gross Profit | 1.00K | 28.00K | -6.72M | -4.89M | -1.65M | -2.63M |
| EBITDA | -15.64M | -14.36M | -15.16M | -16.79M | 61.90M | -16.14M |
| Net Income | -14.25M | -14.29M | -13.00M | -18.40M | 42.52M | -35.10M |
Balance Sheet | ||||||
| Total Assets | 30.16M | 29.72M | 18.24M | 20.39M | 47.49M | 77.89M |
| Cash, Cash Equivalents and Short-Term Investments | 21.11M | 20.38M | 8.86M | 9.38M | 15.77M | 46.63M |
| Total Debt | 0.00 | 6.50M | 6.53M | 0.00 | 10.02M | 18.62M |
| Total Liabilities | 11.68M | 12.68M | 10.24M | 6.29M | 25.67M | 113.79M |
| Stockholders Equity | 18.48M | 17.04M | 8.00M | 14.11M | 21.81M | -35.89M |
Cash Flow | ||||||
| Free Cash Flow | -11.29M | -11.36M | -12.68M | -17.59M | -28.70M | -31.83M |
| Operating Cash Flow | -11.29M | -11.36M | -12.68M | -17.49M | -28.33M | -30.00M |
| Investing Cash Flow | -17.06M | -14.35M | 3.78M | -528.00K | 36.45M | -26.12M |
| Financing Cash Flow | 26.79M | 22.74M | 12.04M | 3.47M | -507.00K | 41.51M |
Talphera Technical Analysis
Negative
1.10
Price Trends
0.81
Positive
0.86
Negative
0.95
Negative
Market Momentum
>-0.01
Positive
47.68
Neutral
35.51
Neutral
Evaluating momentum and price trends is crucial in stock analysis to make informed investment decisions. For TLPH, the sentiment is Negative. The current price of 1.1 is above the 20-day moving average (MA) of 0.85, above the 50-day MA of 0.81, and above the 200-day MA of 0.95, indicating a neutral trend. The MACD of >-0.01 indicates Positive momentum. The RSI at 47.68 is Neutral, neither overbought nor oversold. The STOCH value of 35.51 is Neutral, not indicating any strong overbought or oversold conditions. Overall, these indicators collectively point to a Negative sentiment for TLPH.
Talphera Risk Analysis
Talphera disclosed 45 risk factors in its most recent earnings report. Talphera reported the most risks in the "Tech & Innovation" category.
Finance & Corporate - Financial and accounting risks. Risks related to the execution of corporate activity and strategy
Latest Risks Added 0 New Risks
Talphera Peers Comparison
UnderperformOutperform
Sector (51)
Name | Overall Rating | Market Cap | P/E Ratio | ROE | Dividend Yield | Revenue Growth | EPS Growth |
|---|---|---|---|---|---|---|---|
51 Neutral | $7.86B | -0.30 | -43.30% | 2.27% | 22.53% | -2.21% | |
51 Neutral | $42.35M | -2.43 | -92.98% | ― | -96.30% | 32.21% | |
47 Neutral | $8.31M | -3.11 | -40.66% | ― | 2.00% | 94.31% | |
44 Neutral | $1.27M | -0.21 | -24.34% | ― | -2.05% | 89.29% | |
42 Neutral | $1.79M | -14.53 | -93.87% | ― | -6.14% | -24.22% |
* Healthcare Sector Average
TLPH
Talphera
0.82
0.34
70.71%
SISI
Shineco
0.30
-21.24
-98.59%
YCBD
cbdMD
0.79
-0.10
-11.01%
SBFM
Sunshine Biopharma
0.25
-1.17
-82.11%
IMCC
IM Cannabis Corp
0.29
-3.19
-91.72%
Talphera Corporate Events
Delistings and Listing ChangesRegulatory Filings and Compliance
Talphera Receives Nasdaq Notice on Minimum Bid Price
Negative
Mar 13, 2026
On March 11, 2026, Talphera, Inc. disclosed that it had received a notice from Nasdaq stating the company was no longer in compliance with the exchange’s $1.00 minimum bid price requirement, after its shares traded below that threshold for 3...
Glossary
BuyA stock rated as a "Buy" is expected to perform better than the overall market or a specific benchmark over the near-to-medium term. This rating suggests the stock is likely to deliver higher returns compared to other stocks in the same sector or market index. Note: This is not investment advice; please consult a financial advisor before making investment decisions.
HoldA stock rated as a "Hold" is expected to perform in line with the overall market or a specific benchmark. This rating indicates that the stock is neither particularly compelling nor unfavorable for investment. Note: This is not investment advice; please consult a financial advisor before making investment decisions.
SellA stock rated as a "Sell" is expected to perform worse than the overall market or a specific benchmark over the near-to-medium term. This rating suggests the stock may deliver lower returns compared to other stocks in the same sector or market index. Note: This is not investment advice; please consult a financial advisor before making investment decisions.
Disclaimer
This AI Analyst Stock Report is automatically generated by our AI systems using advanced algorithms and publicly available financial, technical, and market data. While the information provided aims to be accurate and insightful, it is intended for informational purposes only and should not be considered financial advice. Any content created by an AI (Artificial Intelligence) system may contain inaccuracies and/or contain errors. Investing in stocks carries inherent risks, and past performance is not indicative of future results. This report does not account for your personal financial circumstances, objectives, or risk tolerance. Always conduct your own research or consult with a qualified financial advisor before making investment decisions. The analysis and recommendations provided are based on historical and current data and may not fully reflect future market conditions or unexpected developments. Neither the creators of this report nor its affiliated entities guarantee the accuracy, completeness, or reliability of the information presented. Use this report at your own discretion and risk.