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Talphera (TLPH)
NASDAQ:TLPH
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Talphera
(NASDAQ:TLPH)
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Rating:51Neutral
Price Target:
$0.88
▼(-19.91% Downside)
The score is held back primarily by very weak financial performance (minimal revenue, ongoing losses, and continued cash burn). The latest earnings call adds support through improved liquidity and reduced expense guidance, but trial delays and conditional financing keep execution risk elevated. Technicals are mixed with some longer-term improvement but softer near-term signals, while valuation remains unattractive due to negative earnings and no dividend.
Positive Factors
Regulatory Advantage
Breakthrough Device designation materially shortens regulatory review and enables faster FDA interaction. This reduces time-to-market and regulatory uncertainty for Niyad, improving the probability of approval and creating a durable competitive edge versus slower-to-approve alternatives.
Strategic Financing & Partnership
A $17M first tranche and a $5M strategic CorMedix investment both bolster liquidity and validate the program. CorMedix’s board seat and right of first negotiation strengthen commercial/exit optionality and potential partnership or acquisition pathways over the medium term.
Improved Runway from Cash & Cost Cuts
A $21.3M cash position combined with lower 2025 cash operating expense guidance ($14–$15M) extends runway into anticipated late-2026 regulatory milestones. This provides durable funding visibility to complete pivotal work absent immediate commercial revenue.
Negative Factors
Weak Financial Performance & Cash Burn
Minimal revenue and persistent ~-$11M annual cash burn leave the company dependent on external capital to fund operations. Without commercial sales, profitability and free-cash-flow remain unattainable until regulatory approval and successful market launch, raising long-term dilution risk.
Financing Contingencies & Leverage
Reliance on a contingent $12M tranche tied to clinical success and a stock-price trigger increases execution and market-risk exposure. Rising debt and past zero-debt comparisons indicate higher leverage, making future operations sensitive to financing conditions and potential dilution.
Clinical Execution Risk from Trial Delays
Slower site activations and enrollment delays materially extend timelines to pivotal readouts and approval. Prolonged clinical timelines increase cumulative burn, heighten the need for further financing, and raise the probability of operational setbacks before commercialization can generate sustainable revenue.
Talphera (TLPH) vs. SPDR S&P 500 ETF (SPY)
Market Cap
$37.14M
Dividend YieldN/A
Average Volume (3M)2.97M
Price to Earnings (P/E)―
Beta (1Y)0.73
Revenue Growth-90.04%
EPS Growth44.40%
CountryUS
Employees13
SectorHealthcare
Sector Strength45
IndustryDrug Manufacturers - Specialty & Generic
Share Statistics
EPS (TTM)-0.11
Shares Outstanding46,609,620
10 Day Avg. Volume675,544
30 Day Avg. Volume2,969,035
Financial Highlights & Ratios
PEG Ratio0.02
Price to Book (P/B)1.69
Price to Sales (P/S)0.00
P/FCF Ratio-1.07
Enterprise Value/Market Cap0.52
Enterprise Value/Revenue686.70
Enterprise Value/Gross Profit-7.80
Enterprise Value/Ebitda-1.76
Forecast
1Y Price Target
$3.25Price Target Upside195.45% Upside
Rating ConsensusModerate Buy
Number of Analyst Covering2
EPS Forecast (FY)N/A
Revenue Forecast (FY)N/A
Talphera Business Overview & Revenue Model
Company DescriptionTalphera, 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 under an investigational device exemption as an anticoagulant for the extracorporeal circuit. It is also developing LTX-608, an anti-inflammatory and antiviral potential for the treatment of multiple conditions, including COVID-19, disseminated intravascular coagulation (DIC), acute respiratory distress syndrome (ARDS), and acute pancreatitis; Fedsyra, a pre-filled ephedrine syringe; and PFS-02, a pre-filled phenylephrine syringe. The company was formerly known as AcelRx Pharmaceuticals, Inc. and changed its name to Talphera, Inc. in January 2024. Talphera, Inc. was incorporated in 2005 and is headquartered in San Mateo, California.
How the Company Makes MoneyTalphera generates revenue primarily through its cloud computing and SaaS offerings. The company provides subscription-based services for its software products, which include productivity tools, data analytics platforms, and customer relationship management (CRM) systems. Additionally, Talphera offers customized IT consulting services, charging clients based on project scope and duration. Significant partnerships with major technology firms enhance its service offerings and extend its market reach, contributing to its earnings. The company's revenue model emphasizes recurring income through subscription renewals and long-term consulting contracts, ensuring a stable and predictable cash flow.
Talphera Earnings Call Summary
Earnings Call Date:Nov 12, 2025
(Q3-2025)
| % Change Since: |
Next Earnings Date:Mar 05, 2026
Earnings Call Sentiment Neutral
The earnings call presented a mix of positive and negative aspects. While there are significant achievements in financial stability, regulatory clarity, and enrollment progress, the delays in site activation and enrollment challenges pose notable concerns.Q3-2025 Updates
Positive Updates
Successful Financing
Completed the first closing of $17 million in a two-tranche financing, including a strategic investment by CorMedix, which provides a 60-day exclusive negotiation period for a potential acquisition.
Positive Enrollment in Nephro Study
Enrollment at existing target profile sites continues to impress, with accelerated enrollment rate following restructuring of the study.
Clear Regulatory Path
NIAID has a breakthrough designation from the FDA, providing efficient access for quick reviews and responses.
Cost Efficiency
Cash operating expenses for 2025 decreased to $3.4 million from $3.7 million in 2024 due to reductions in personnel and SG&A expenses.
Strong Financial Position
Cash balance at September 30, 2025, was $21.3 million, expected to provide sufficient capital until at least anticipated NIAID PMA approval in late 2026.
Negative Updates
Delays in Site Activation
The initiation of six additional target profile sites has been slower than anticipated, delaying the study completion to the first half of next year.
Enrollment Challenges
The new target sites are enrolling patients at a similar rate to the existing ones, and delays in site activation further impact enrollment speed.
Federal Funding Volatility
Some sites, like the Veterans Affairs Medical Center, experienced delays due to cuts in personnel, affecting their timeline by three to four months.
Company Guidance
During the third quarter 2025 financial results call, Talphera, Inc. provided updates on its financial position and progress in the nephro study. The company completed the first closing of $17 million in a two-tranche financing, including a $5 million strategic minority investment from CorMedix. Additionally, $12 million was invested by institutional investors, with a commitment for another $12 million contingent on achieving the nephro study's primary endpoint and maintaining a stock price above $0.69 per share for five consecutive days. The study's enrollment rate improved at existing sites, but delays in activating new sites pushed expected completion to the first half of 2026. Talphera's cash balance as of September 30, 2025, was $21.3 million, with cash operating expenses for the year expected to range between $14 million and $15 million, down from previous guidance due to study delays. The company remains confident in the Nefamostat program's low clinical, regulatory, and commercial risks, aiming for FDA approval of NIAID by late 2026.Talphera Financial Statement Overview
Summary
Financials remain weak: TTM revenue is minimal (~$0.03M) with a sizable net loss (~$12.4M) and materially negative operating/free cash flow (~-$11.2M), indicating ongoing cash burn. Positives include narrower losses versus 2023 and a balance sheet with positive equity (~$19.2M) and assets exceeding debt, but rising leverage and continued burn keep financing risk elevated.Income Statement
Profitability remains very weak in TTM (Trailing-Twelve-Months), with a net loss of about $12.4M on minimal revenue (~$0.03M), implying heavy ongoing operating costs relative to the current commercial base. While revenue shows a positive growth rate in TTM, the business is still not operating at a sustainable scale and margins are highly pressured. The one notable bright spot is that losses have narrowed versus 2023 (net loss improved from roughly $18.4M to ~$12.4M), but overall earnings quality and consistency remain poor.14
Very Negative
Balance Sheet
The balance sheet is mixed. On the positive side, TTM (Trailing-Twelve-Months) stockholders’ equity is positive (~$19.2M) and assets (~$30.7M) exceed debt (~$6.5M), suggesting the company is not currently balance-sheet insolvent. However, leverage has risen versus 2023 (when reported debt was $0) and the company is generating negative returns for shareholders (negative return on equity in recent periods). This combination points to ongoing dilution/financing risk if losses continue.45
Neutral
Cash Flow
Cash generation is a key weakness: operating cash flow and free cash flow are both meaningfully negative in TTM (Trailing-Twelve-Months) (about -$11.2M), indicating continued cash burn to fund operations. Cash burn has improved versus 2024 (operating cash flow moved from roughly -$12.7M to -$11.2M), but free cash flow growth is still negative in TTM and the company remains dependent on external funding or cash reserves to sustain operations.18
Very Negative
| Breakdown | TTM | Dec 2024 | Dec 2023 | Dec 2022 | Dec 2021 | Dec 2020 |
|---|---|---|---|---|---|---|
Income Statement | ||||||
| Total Revenue | 28.00K | 0.00 | 651.00K | 0.00 | 378.00K | 5.42M |
| Gross Profit | -2.46M | -6.72M | -4.89M | -1.65M | -2.63M | -616.00K |
| EBITDA | -10.90M | -15.16M | -16.79M | 61.90M | -16.14M | -35.22M |
| Net Income | -12.39M | -13.00M | -18.40M | 42.52M | -35.10M | -40.38M |
Balance Sheet | ||||||
| Total Assets | 30.74M | 18.24M | 20.39M | 47.49M | 77.89M | 66.30M |
| Cash, Cash Equivalents and Short-Term Investments | 21.29M | 8.86M | 9.38M | 15.77M | 46.63M | 42.89M |
| Total Debt | 6.50M | 6.53M | 0.00 | 10.02M | 18.62M | 25.60M |
| Total Liabilities | 11.56M | 10.24M | 6.29M | 25.67M | 113.79M | 122.05M |
| Stockholders Equity | 19.18M | 8.00M | 14.11M | 21.81M | -35.89M | -55.75M |
Cash Flow | ||||||
| Free Cash Flow | -11.18M | -12.68M | -17.59M | -28.70M | -31.83M | -40.36M |
| Operating Cash Flow | -11.18M | -12.68M | -17.49M | -28.33M | -30.00M | -38.51M |
| Investing Cash Flow | -17.82M | 3.78M | -528.00K | 36.45M | -26.12M | 34.14M |
| Financing Cash Flow | 21.34M | 12.04M | 3.47M | -507.00K | 41.51M | 16.96M |
Talphera Technical Analysis
Negative
1.10
Price Trends
1.11
Negative
1.13
Negative
0.81
Negative
Market Momentum
-0.08
Positive
22.08
Positive
15.85
Positive
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 0.98, below the 50-day MA of 1.11, and above the 200-day MA of 0.81, indicating a bearish trend. The MACD of -0.08 indicates Positive momentum. The RSI at 22.08 is Positive, neither overbought nor oversold. The STOCH value of 15.85 is Positive, not indicating any strong overbought or oversold conditions. Overall, these indicators collectively point to a Negative sentiment for TLPH.
Talphera Risk Analysis
Talphera disclosed 49 risk factors in its most recent earnings report. Talphera reported the most risks in the "Finance & Corporate" 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 | $37.14M | -2.08 | -86.48% | ― | -90.04% | 44.40% | |
49 Neutral | $9.87M | -0.24 | -44.42% | ― | -1.50% | 80.17% | |
44 Neutral | $5.94M | -0.62 | -24.34% | ― | 13.24% | 98.80% | |
40 Underperform | $6.24M | -1.44 | -93.87% | ― | -0.74% | 81.49% |
* Healthcare Sector Average
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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.