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Talphera (TLPH)
NASDAQ:TLPH

Talphera (TLPH) AI Stock Analysis

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TLPH

Talphera

(NASDAQ:TLPH)

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Neutral 51 (OpenAI - 5.2)
Rating:51Neutral
Price Target:
$1.00
▼(-9.09% 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)

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
Talphera's financial performance is concerning, with negative net income and declining revenue. Despite a reduction in debt and some equity improvement, the company faces operational inefficiencies and negative cash flows.
Income Statement
14
Very Negative
Talphera's income statement reveals significant challenges with consistently negative net income and declining revenue. The company has experienced a decrease in total revenue from $5.42 million in 2020 to $0 in 2024, indicating a severe contraction in sales. Gross profit margins have also been negative, demonstrating inefficiencies in production or sales. EBIT and EBITDA margins are substantially negative, highlighting ongoing operational difficulties.
Balance Sheet
45
Neutral
The balance sheet shows a reduction in total debt over recent years, leading to a current Debt-to-Equity ratio of zero, which is positive. However, the company has struggled with equity deficits in previous years, though it has improved to positive equity in 2024. The Equity Ratio remains low, suggesting limited financial stability. The return on equity is not calculable given the fluctuating and negative net income history.
Cash Flow
18
Very Negative
Cash flow analysis reveals consistent negative free cash flow, indicating challenges in generating operational cash. However, there is some improvement in operating cash flow from 2023 to 2024, albeit still negative. The company's reliance on financing activities to support cash flows is evident, highlighting a potential risk if external funding sources become restricted.
BreakdownTTMDec 2024Dec 2023Dec 2022Dec 2021Dec 2020
Income Statement
Total Revenue28.00K0.00651.00K0.00378.00K5.42M
Gross Profit-2.46M-6.72M-4.89M-1.65M-2.63M-616.00K
EBITDA-10.90M-15.16M-16.79M61.90M-16.14M-35.22M
Net Income-12.39M-13.00M-18.40M42.52M-35.10M-40.38M
Balance Sheet
Total Assets30.74M18.24M20.39M47.49M77.89M66.30M
Cash, Cash Equivalents and Short-Term Investments21.29M8.86M9.38M15.77M46.63M42.89M
Total Debt6.50M6.53M0.0010.02M18.62M25.60M
Total Liabilities11.56M10.24M6.29M25.67M113.79M122.05M
Stockholders Equity19.18M8.00M14.11M21.81M-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-17.82M3.78M-528.00K36.45M-26.12M34.14M
Financing Cash Flow21.34M12.04M3.47M-507.00K41.51M16.96M

Talphera Technical Analysis

Technical Analysis Sentiment
Negative
Last Price1.10
Price Trends
50DMA
1.20
Negative
100DMA
1.09
Negative
200DMA
0.78
Positive
Market Momentum
MACD
-0.04
Positive
RSI
37.62
Neutral
STOCH
15.62
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 below the 20-day moving average (MA) of 1.11, below the 50-day MA of 1.20, and above the 200-day MA of 0.78, indicating a neutral trend. The MACD of -0.04 indicates Positive momentum. The RSI at 37.62 is Neutral, neither overbought nor oversold. The STOCH value of 15.62 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

Overall Rating
UnderperformOutperform
Sector (51)
Financial Indicators
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
$46.26M-2.65-86.48%-90.04%44.40%
47
Neutral
$10.17M-0.24-44.42%-1.50%80.17%
44
Neutral
$5.99M-0.66-24.34%13.24%98.80%
40
Underperform
$7.08M-1.75-93.87%-0.74%81.49%
* Healthcare Sector Average
Performance Comparison
Ticker
Company Name
Price
Change
% Change
TLPH
Talphera
1.00
0.33
49.25%
SISI
Shineco
0.21
-84.29
-99.75%
YCBD
cbdMD
0.92
-3.10
-77.04%
SBFM
Sunshine Biopharma
1.22
-1.68
-57.93%
IMCC
IM Cannabis Corp
1.38
-0.81
-37.12%

Talphera Corporate Events

Executive/Board ChangesShareholder MeetingsStock Split
Talphera Holds Annual Meeting with Key Decisions
Neutral
Oct 24, 2025

On October 23, 2025, Talphera held its Annual Meeting where several key proposals were voted on by shareholders. Vincent J. Angotti, Stephen J. Hoffman, M.D., Ph.D., and Abhinav Jain were elected as Class II directors to serve until the 2028 Annual Meeting. The selection of BPM LLP as the independent registered public accounting firm was ratified, and the compensation for the company’s named executive officers was approved. Additionally, the company decided to hold an annual advisory vote on executive compensation. The 2020 Equity Incentive Plan and the 2011 Employee Stock Purchase Plan were both approved. An amendment to the company’s Certificate of Incorporation was also approved, allowing for a potential reverse stock split to maintain compliance with Nasdaq’s minimum bid price requirements, although the company had already regained compliance as of October 20, 2025.

The most recent analyst rating on (TLPH) stock is a Buy with a $3.00 price target. To see the full list of analyst forecasts on Talphera stock, see the TLPH Stock Forecast page.

Delistings and Listing ChangesRegulatory Filings and Compliance
Talphera Regains Nasdaq Compliance After Grace Period
Positive
Oct 22, 2025

Talphera faced a compliance issue with Nasdaq’s minimum bid price requirement as its stock price fell below $1.00 for 30 consecutive business days, leading to a transfer from The Nasdaq Global Select Market to The Nasdaq Capital Market. After receiving an additional 180-day grace period, Talphera successfully regained compliance on October 20, 2025, as its stock price met the required threshold for 10 consecutive business days.

The most recent analyst rating on (TLPH) stock is a Buy with a $3.00 price target. To see the full list of analyst forecasts on Talphera stock, see the TLPH Stock Forecast page.

Executive/Board ChangesM&A Transactions
Talphera Appoints Joseph Todisco to Board of Directors
Neutral
Oct 16, 2025

On October 14, 2025, Talphera, Inc. appointed Joseph Todisco as a Class III member of its board of directors and member of the compensation committee, with his term expiring at the 2026 annual meeting of stockholders. Mr. Todisco, currently the CEO of CorMedix Inc., has a rich background in the pharmaceutical industry, having held senior roles at Amneal Pharmaceuticals and co-founding Gemini Laboratories. His appointment is linked to a securities purchase agreement with CorMedix, which grants CorMedix the right to designate a board member as long as they hold at least 25% of their purchased shares. Additionally, CorMedix has a Right of First Negotiation for acquiring Talphera, contingent on the results of the NEPHRO CRRT clinical study for Talphera’s product candidate Niyad.

The most recent analyst rating on (TLPH) stock is a Buy with a $3.00 price target. To see the full list of analyst forecasts on Talphera stock, see the TLPH Stock Forecast page.

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.Date of analysis: Jan 09, 2026