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Talphera (TLPH)
NASDAQ:TLPH

Talphera (TLPH) AI Stock Analysis

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Talphera

(NASDAQ:TLPH)

41Neutral
Talphera faces significant financial hurdles with negative income and cash flows, impacting its overall score. While technical indicators are mixed, the stock is underperforming key moving averages. Valuation remains a challenge with a negative P/E ratio. The earnings call provided some optimism with regulatory approvals and financing, but operational challenges persist. The combination of these factors results in a low overall score.
Positive Factors
Clinical Advantages
Niyad can address the safety concerns associated with existing anticoagulants and may potentially be used in patients at greater risk of bleeding.
Regulatory Approval
Talphera reached an agreement with the FDA to reduce the number of patients for the Phase 3 NEPHRO CRRT study to 70 patients, from 166, allowing the trial to complete faster and reduce potential total cash expenses.
Negative Factors
Enrollment Issues
Patient enrollment for the NEPHRO CRRT study has been sluggish, with only six patients enrolled since November 2024.
Regulatory Risks
Key risks to the rating and price target include failed or equivocal trial results and failure to secure FDA approval for Niyad.

Talphera (TLPH) vs. S&P 500 (SPY)

Talphera Business Overview & Revenue Model

Company DescriptionTalphera (TLPH) is a dynamic technology company specializing in cloud computing solutions and software development. Operating within the tech sector, Talphera offers a range of services including cloud infrastructure management, software as a service (SaaS) products, and IT consulting. The company is committed to delivering innovative solutions tailored to meet the needs of businesses of all sizes, ensuring scalability, security, and efficiency in digital transformation.
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 Financial Statement Overview

Summary
Talphera is facing significant financial challenges, with negative margins and declining revenue. Despite having no debt, the negative equity and cash flow issues indicate operational inefficiencies and liquidity concerns.
Income Statement
20
Very Negative
Talphera's income statement reveals a concerning financial situation. The company has a negative gross profit margin and net profit margin, indicating that it is not generating enough revenue to cover its costs. Revenue has been declining, and EBIT and EBITDA margins are significantly negative, suggesting inefficiency in operations and high operational costs. The substantial net losses reflect the struggles in achieving profitability.
Balance Sheet
35
Negative
The balance sheet shows a mixed financial position. While Talphera has no debt in the most recent period, indicating a lack of leverage risk, it has a relatively low equity ratio due to small stockholders' equity and significant liabilities. The return on equity is negative, as the company is incurring losses. Despite these weaknesses, the company has managed to maintain a positive cash position, which could provide some stability.
Cash Flow
25
Negative
Cash flow analysis reveals challenges in generating cash internally. The operating cash flow to net income ratio is negative, indicating inefficiencies in converting sales into cash. The free cash flow is negative, with no significant growth, highlighting ongoing cash flow struggles. While financing activities have provided some relief, the reliance on external financing may not be sustainable long-term.
Breakdown
TTMDec 2023Dec 2022Dec 2021Dec 2020Dec 2019
Income StatementTotal Revenue
281.00K651.00K1.77M2.82M5.42M2.29M
Gross Profit
-3.16M-4.89M-820.00K-935.00K-616.00K-4.52M
EBIT
-16.54M-16.89M-25.30M-35.97M-40.96M-54.20M
EBITDA
-15.15M-9.84M-17.20M-30.83M-35.22M-49.03M
Net Income Common Stockholders
-15.65M-18.40M47.76M-35.10M-40.38M-53.24M
Balance SheetCash, Cash Equivalents and Short-Term Investments
3.68M9.38M15.77M46.63M42.89M66.14M
Total Assets
6.83M20.39M47.49M77.89M66.30M91.36M
Total Debt
12.01M0.005.36M18.62M25.60M121.79M
Net Debt
8.95M-5.72M-9.91M10.96M-1.68M107.11M
Total Liabilities
72.72M6.29M25.67M113.79M122.05M132.77M
Stockholders Equity
-65.89M14.11M21.81M-35.89M-55.75M-41.42M
Cash FlowFree Cash Flow
-14.38M-17.59M-28.70M-31.83M-40.36M-54.65M
Operating Cash Flow
-14.38M-17.49M-28.33M-30.00M-38.51M-51.18M
Investing Cash Flow
130.00K-528.00K36.45M-26.12M34.14M-36.56M
Financing Cash Flow
11.98M3.47M-507.00K41.51M16.96M14.45M

Talphera Technical Analysis

Technical Analysis Sentiment
Negative
Last Price0.52
Price Trends
50DMA
0.54
Negative
100DMA
0.58
Negative
200DMA
0.72
Negative
Market Momentum
MACD
>-0.01
Negative
RSI
49.63
Neutral
STOCH
61.24
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 0.52 is above the 20-day moving average (MA) of 0.50, below the 50-day MA of 0.54, and below the 200-day MA of 0.72, indicating a neutral trend. The MACD of >-0.01 indicates Negative momentum. The RSI at 49.63 is Neutral, neither overbought nor oversold. The STOCH value of 61.24 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 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 (52)
Financial Indicators
Name
Overall Rating
Market Cap
P/E Ratio
ROE
Dividend Yield
Revenue Growth
EPS Growth
52
Neutral
$5.22B3.55-44.39%2.82%15.40%-0.09%
51
Neutral
$8.31M-126.34%23.21%57.43%
47
Neutral
$10.72M-52.79%82.77%-87.95%
44
Neutral
$18.98M-193.31%136.85%-49.01%
41
Neutral
$13.22M-160.26%19.21%
41
Neutral
$10.69M-117.65%-100.00%65.76%
* Healthcare Sector Average
Performance Comparison
Ticker
Company Name
Price
Change
% Change
TLPH
Talphera
0.52
-0.70
-57.38%
RLMD
Relmada Therapeutics
0.39
-3.09
-88.79%
IMRN
Immuron
1.91
-0.40
-17.32%
MSPR
Lionheart Acquisition II
1.91
-17.84
-90.33%
INBS
Intelligent Bio Solutions
1.36
-0.98
-41.88%

Talphera Earnings Call Summary

Earnings Call Date:May 14, 2025
(Q4-2024)
|
% Change Since: 4.00%|
Next Earnings Date:Aug 18, 2025
Earnings Call Sentiment Positive
The earnings call detailed significant progress, including FDA approvals and financial backing, improving the outlook for the NEPHRO CRRT study. However, challenges with initial study sites and uncertainty regarding enrollment timelines were noted.
Q4-2024 Updates
Positive Updates
Successful FDA Approvals
The FDA approved a reduction in the NEPHRO CRRT study size from 166 patients to 70, while maintaining 90% power for the primary endpoint. Additionally, two major protocol changes were approved, improving patient enrollment criteria.
Private Placement Investment Secured
Talphera secured a private placement investment of up to $14.8 million, contingent on achieving certain milestones, providing necessary capital for the NEPHRO study completion.
Reduction in Operating Expenses
Operating expenses were reduced, with combined R&D and SG&A expenses for Q4 2024 totaling $3 million, down from $4.6 million in Q4 2023.
Expansion of Enrollment-Ready Sites
Talphera increased enrollment-ready sites to eight, with plans to reach 13 by mid-year 2025, potentially increasing patient enrollment rates.
Negative Updates
Challenges with Initial Study Sites
Initial study sites underperformed due to inappropriate ICU types and principal investigators not aligned with study needs, causing delays in patient enrollment.
Delayed Enrollment Completion
Despite protocol changes, the exact timeline for reaching patient enrollment milestones remains uncertain, with concerns about meeting year-end completion.
Company Guidance
During the Talphera Fourth Quarter and Full Year 2024 Financial Results Conference call, significant updates were provided regarding the NEPHRO CRRT study. The company anticipates completing this study by the end of 2025, with an FDA submission for Niyad expected in the first quarter of 2026. A major highlight was the FDA's approval to reduce the trial size from 166 to 70 patients while retaining a 90% power for the primary endpoint. Talphera also secured a private placement investment of up to $14.8 million, structured in three tranches tied to patient enrollment milestones and stock performance. The company aims to achieve 13 enrollment-ready sites by mid-2025, with new protocol changes expected to accelerate patient enrollment. Talphera reported a decrease in combined R&D and SG&A expenses to $3 million for Q4 2024, down from $4.6 million in Q4 2023, and plans to maintain cash operating expenses in the range of $18 million to $19 million for 2025.
Glossary
OutperformA stock rated as "Outperform" is expected to perform better than the overall market or a specific benchmark over the near-to-medium term. This rating suggests that the stock is likely to deliver higher returns compared to the average returns of other stocks in the same sector or market index. Investors might consider this stock a good buying opportunity.
NeutralA stock rated as "Neutral" is expected to perform in line with the overall market or a specific benchmark. This rating indicates that the stock is neither particularly attractive nor unattractive for investment. Investors may consider holding onto the stock, as it is not expected to either significantly outperform or underperform the market.
UnderperformA stock rated as "Underperform" is expected to perform worse than the overall market or a specific benchmark over the near-to-medium term. This rating suggests that the stock may deliver lower returns compared to the average returns of other stocks in the same sector or market index. Investors might consider selling the stock or avoiding it as an investment.

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.