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Talphera (TLPH)
NASDAQ:TLPH
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Talphera
(NASDAQ:TLPH)
34Underperform
Positive Factors
Product Potential
There is a positive outlook on Niyad (nafamostat) and its potential as a regional anticoagulant for the extracorporeal circuit (ECC).
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, which should allow the trial to complete faster and reduce potential total cash expenses.
Negative Factors
Enrollment Challenges
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)
Market Cap
$8.74M
Dividend YieldN/A
Average Volume (3M)51.39K
Price to Earnings (P/E)―
Beta (1Y)1.43
Revenue Growth-100.00%
EPS Growth65.76%
CountryUS
Employees15
SectorHealthcare
Sector Strength78
IndustryDrug Manufacturers - Specialty & Generic
Share Statistics
EPS (TTM)-0.51
Shares Outstanding17,098,345
10 Day Avg. Volume76,666
30 Day Avg. Volume51,393
Financial Highlights & Ratios
PEG RatioN/A
Price to Book (P/B)N/A
Price to Sales (P/S)38.46
Price to Cash Flow (P/CF)-0.90
P/FCF Ratio0.00
Enterprise Value/Market CapN/A
Enterprise Value/RevenueN/A
Enterprise Value/Gross ProfitN/A
Enterprise Value/EbitdaN/A
Forecast
1Y Price Target
$4.33Price Target Upside783.67% Upside
Rating ConsensusStrong Buy
Number of Analyst Covering3
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 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
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.20
Very Negative
Balance Sheet
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.35
Negative
Cash Flow
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.25
Negative
| Breakdown | |||||
| TTM | Dec 2023 | Dec 2022 | Dec 2021 | Dec 2020 | Dec 2019 |
|---|---|---|---|---|---|
| Income Statement | Total Revenue | ||||
| 281.00K | 651.00K | 1.77M | 2.82M | 5.42M | 2.29M | 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 | -18.40M | 47.76M | -35.10M | -40.38M | -53.24M |
| Balance Sheet | Cash, Cash Equivalents and Short-Term Investments | ||||
| 3.68M | 9.38M | 15.77M | 46.63M | 42.89M | 66.14M | Total Assets |
| 6.83M | 20.39M | 47.49M | 77.89M | 66.30M | 91.36M | Total Debt |
| 12.01M | 0.00 | 5.36M | 18.62M | 25.60M | 121.79M | Net Debt |
| 8.95M | -5.72M | -9.91M | 10.96M | -1.68M | 107.11M | Total Liabilities |
| 72.72M | 6.29M | 25.67M | 113.79M | 122.05M | 132.77M | Stockholders Equity |
| -65.89M | 14.11M | 21.81M | -35.89M | -55.75M | -41.42M |
| Cash Flow | Free 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 | -528.00K | 36.45M | -26.12M | 34.14M | -36.56M | Financing Cash Flow |
| 11.98M | 3.47M | -507.00K | 41.51M | 16.96M | 14.45M |
Talphera Technical Analysis
Negative
0.49
Price Trends
0.59
Negative
0.63
Negative
0.77
Negative
Market Momentum
>-0.01
Positive
40.47
Neutral
31.66
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 0.49 is below the 20-day moving average (MA) of 0.58, below the 50-day MA of 0.59, and below the 200-day MA of 0.77, indicating a bearish trend. The MACD of >-0.01 indicates Positive momentum. The RSI at 40.47 is Neutral, neither overbought nor oversold. The STOCH value of 31.66 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 (48)
Financial Indicators
Name | Overall Rating | Market Cap | P/E Ratio | ROE | Dividend Yield | Revenue Growth | EPS Growth |
|---|---|---|---|---|---|---|---|
52 Neutral | $9.16M | ― | -279.80% | ― | 23.21% | 57.43% | |
48 Neutral | $6.27B | 1.17 | -48.19% | 2.68% | 17.28% | 1.24% | |
46 Neutral | $8.40M | ― | -52.79% | ― | 82.77% | -87.95% | |
42 Neutral | $9.04M | ― | -132.33% | ― | ― | 19.21% | |
34 Underperform | $8.74M | ― | -117.65% | ― | -100.00% | 65.76% | |
31 Underperform | $9.34M | ― | -33.24% | ― | 24.77% | 13.53% |
* Healthcare Sector Average
Performance Comparison
TLPH
Talphera
0.49
-0.70
-58.82%
RLMD
Relmada Therapeutics
0.25
-4.55
-94.79%
IMRN
Immuron
1.72
-1.04
-37.68%
MSPR
Lionheart Acquisition II
1.34
-33.91
-96.20%
INBS
Intelligent Bio Solutions
1.15
-2.47
-68.23%
NEUP
Neuphoria Therapeutics
4.65
-7.59
-62.01%
Talphera Earnings Call Summary
Earnings Call Date: Mar 31, 2025 | % Change Since: -2.00% | Next Earnings Date: May 19, 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.Highlights
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.
Lowlights
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.