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Talphera (TLPH)
NASDAQ:TLPH
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Talphera (TLPH) AI Stock Analysis

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TLPH

Talphera

(NASDAQ:TLPH)

Rating:41Neutral
Price Target:
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
Funding
The private placement with Nantahala Capital, Rosalind Advisors, and CEO Vince Angotti provides Talphera with significant funding, supporting its initiatives and potentially strengthening its financial position.
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, which should allow the trial to complete faster and reduce potential total cash expenses.
Study Progress
Recent sites initiated have been enrolling patients faster and more steadily than prior legacy sites.
Negative Factors
Patient Enrollment
Patient enrollment for the NEPHRO CRRT study has been sluggish, with only six patients enrolled since November 2024.
Study Timeline
Management's expectation to complete the study by the end of 2025 suggests confidence in the trial's progress and timeline.

Talphera (TLPH) vs. SPDR S&P 500 ETF (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 Earnings Call Summary

Earnings Call Date:Aug 14, 2025
(Q2-2025)
|
% Change Since: 13.95%|
Next Earnings Date:Nov 17, 2025
Earnings Call Sentiment Positive
The earnings call presented a positive outlook due to the significant progress in accelerating NEPHRO study enrollment, reducing cash operating expenses, and advancing regulatory interactions. However, challenges with supply chain issues and reliance on future financing were noted. Despite these challenges, the overall sentiment is positive due to the significant progress and strategic adjustments made.
Q2-2025 Updates
Positive Updates
Acceleration of NEPHRO Study Enrollment
The NEPHRO study enrollment has more than doubled since May, with a strong acceleration in the enrollment rate over the last 6 weeks, primarily from new target profile sites. The number of enrolled patients increased significantly due to strategic changes, including reducing the study size and adjusting site profiles.
Reduction in Cash Operating Expenses
Talphera reduced its 2025 expected cash operating expense guidance to $16-17 million from the previous $17-19 million. The cash operating expenses for Q2 2025 were $3.7 million, a decrease from $4.3 million in Q2 2024, mainly due to reductions in personnel and administrative expenses.
Progress in Compassionate Use IDE
Talphera is advancing a compassionate use IDE for nafamostat with institutions interested in using it for patients not responding well to other anticoagulants. This indicates growing interest and potential market demand for nafamostat.
Breakthrough Designation from FDA
Nafamostat has a breakthrough designation from the FDA, which facilitates efficient access to the agency and quick review and response times, minimizing regulatory risks.
Negative Updates
Challenges with Legacy Study Sites
The initial NEPHRO study sites were not optimized for CRRT studies, leading to low enrollment rates. These sites were more focused on cardiac and surgical ICUs rather than medical ICUs, which are more relevant for CRRT.
Heparin and Citrate Supply Chain Issues
There have been ongoing supply chain issues with heparin and citrate, which are used as anticoagulants. This creates unpredictability and potential shortages for healthcare providers.
Dependence on Future Financing
The company requires additional financing to reach the PMA filing stage. The ability to secure future tranches of funding depends on achieving patient enrollment milestones and potentially meeting stock price conditions.
Company Guidance
In the Talphera Second Quarter 2025 Financial Results Conference Call, the company provided significant updates on their NEPHRO clinical study, highlighting an acceleration in patient enrollment. The study size was reduced from 166 to 70 patients, facilitating faster enrollment, with nine patients enrolled over the last six weeks. Additionally, six new clinical sites are expected to start enrolling by the end of the third quarter. The company's cash operating expenses for the second quarter of 2025 were reported at $3.7 million, down from the previous year's $4.3 million. Talphera also reduced its 2025 cash operating expense guidance to $16-$17 million. The company had a cash balance of $6.8 million as of June 30, 2025, which, along with expected proceeds from milestone-driven financing tranches, is projected to support operations through study completion.

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
10
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
30
Negative
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
20
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 Revenue27.00K0.00651.00K1.77M2.82M5.42M
Gross Profit1.32M-6.72M340.00K-820.00K-935.00K-616.00K
EBITDA-11.38M-15.25M-9.84M61.90M-30.83M-35.22M
Net Income-11.30M-13.00M-18.40M47.76M-35.10M-40.38M
Balance Sheet
Total Assets16.52M18.24M20.39M47.49M77.89M66.30M
Cash, Cash Equivalents and Short-Term Investments6.79M8.86M9.38M15.77M46.63M42.89M
Total Debt6.50M6.53M0.005.36M103.91M25.60M
Total Liabilities9.89M10.23M6.29M25.67M113.79M122.05M
Stockholders Equity6.63M8.00M14.11M21.81M-35.89M-55.75M
Cash Flow
Free Cash Flow-11.61M-12.68M-17.59M-28.70M-31.83M-40.36M
Operating Cash Flow-11.61M-12.68M-17.49M-28.33M-30.00M-38.51M
Investing Cash Flow600.00K3.78M-528.00K36.45M-26.12M34.14M
Financing Cash Flow4.38M12.04M3.47M-507.00K41.51M16.96M

Talphera Technical Analysis

Technical Analysis Sentiment
Positive
Last Price0.49
Price Trends
50DMA
0.45
Positive
100DMA
0.48
Positive
200DMA
0.57
Negative
Market Momentum
MACD
<0.01
Negative
RSI
65.87
Neutral
STOCH
32.23
Neutral
Evaluating momentum and price trends is crucial in stock analysis to make informed investment decisions. For TLPH, the sentiment is Positive. The current price of 0.49 is above the 20-day moving average (MA) of 0.43, above the 50-day MA of 0.45, and below the 200-day MA of 0.57, indicating a neutral trend. The MACD of <0.01 indicates Negative momentum. The RSI at 65.87 is Neutral, neither overbought nor oversold. The STOCH value of 32.23 is Neutral, not indicating any strong overbought or oversold conditions. Overall, these indicators collectively point to a Positive 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
$7.77B-0.12-39.07%2.21%22.68%-1.42%
46
Neutral
$12.07M-52.79%82.77%-87.95%
46
Neutral
$13.11M-186.64%-1.90%87.72%
41
Neutral
$20.62M-175.12%23.17%
41
Neutral
$9.19M-117.56%-93.22%36.97%
37
Underperform
$4.71M-2151.29%76.98%-52.89%
* Healthcare Sector Average
Performance Comparison
Ticker
Company Name
Price
Change
% Change
TLPH
Talphera
0.49
-0.41
-45.56%
RLMD
Relmada Therapeutics
0.61
-2.16
-77.98%
IMRN
Immuron
1.83
-0.86
-31.97%
MSPR
MSP Recovery
0.47
-6.31
-93.07%
INBS
Intelligent Bio Solutions
1.47
0.29
24.58%
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: May 02, 2025