Education
About Us
Working with TipRanks
Follow Us
Talphera (TLPH)
NASDAQ:TLPH
Top Page
Talphera
(NASDAQ:TLPH)
Rating:41Neutral
Price Target:―
Positive Factors
Clinical Trials
The study's updated protocol and higher volume clinical sites are expected to significantly accelerate enrollment in the coming months.
Financial Position
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, which should allow the trial to complete faster and reduce potential total cash expenses.
Negative Factors
Patient Enrollment
Patient enrollment for the NEPHRO CRRT study has been sluggish, with only six patients enrolled since November 2024.
Trial 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. SPDR S&P 500 ETF (SPY)
Market Cap
$10.57M
Dividend YieldN/A
Average Volume (3M)40.11K
Price to Earnings (P/E)―
Beta (1Y)1.18
Revenue Growth-100.00%
EPS Growth65.76%
CountryUS
Employees13
SectorHealthcare
Sector Strength43
IndustryDrug Manufacturers - Specialty & Generic
Share Statistics
EPS (TTM)-0.10
Shares Outstanding20,503,464
10 Day Avg. Volume38,233
30 Day Avg. Volume40,110
Financial Highlights & Ratios
PEG Ratio-0.10
Price to Book (P/B)2.36
Price to Sales (P/S)0.00
P/FCF Ratio-0.78
Enterprise Value/Market Cap0.47
Enterprise Value/Revenue0.35
Enterprise Value/Gross Profit3.45
Enterprise Value/Ebitda-0.09
Forecast
1Y Price Target
$4.50Price Target Upside800.00% Upside
Rating ConsensusModerate Buy
Number of Analyst Covering2
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'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
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.10
Very Negative
Balance Sheet
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.30
Negative
Cash Flow
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.20
Very Negative
| Breakdown | |||||
| TTM | Dec 2024 | Dec 2023 | Dec 2022 | Dec 2021 | Dec 2020 |
|---|---|---|---|---|---|
| Income Statement | Total Revenue | ||||
| 6.71M | 0.00 | 651.00K | 1.77M | 2.82M | 5.42M | Gross Profit |
| 1.43M | 0.00 | -4.89M | -820.00K | -935.00K | -616.00K | EBIT |
| -13.93M | -15.25M | -16.89M | -25.30M | -35.97M | -40.96M | EBITDA |
| -11.75M | -15.25M | -9.84M | -17.20M | -30.83M | -35.22M | Net Income Common Stockholders |
| -11.64M | -13.00M | -18.40M | 47.76M | -35.10M | -40.38M |
| Balance Sheet | Cash, Cash Equivalents and Short-Term Investments | ||||
| 5.39M | 8.86M | 9.38M | 15.77M | 46.63M | 42.89M | Total Assets |
| 14.99M | 18.24M | 20.39M | 47.49M | 77.89M | 66.30M | Total Debt |
| 0.00 | 0.00 | 0.00 | 5.36M | 18.62M | 25.60M | Net Debt |
| -5.39M | -8.86M | -5.72M | -9.91M | 10.96M | -1.68M | Total Liabilities |
| 9.40M | 10.23M | 6.29M | 25.67M | 113.79M | 122.05M | Stockholders Equity |
| 5.60M | 8.00M | 14.11M | 21.81M | -35.89M | -55.75M |
| Cash Flow | Free Cash Flow | ||||
| -13.27M | -12.68M | -17.59M | -28.70M | -31.83M | -40.36M | Operating Cash Flow |
| -13.27M | -12.68M | -17.49M | -28.33M | -30.00M | -38.51M | Investing Cash Flow |
| 6.51M | 3.78M | -528.00K | 36.45M | -26.12M | 34.14M | Financing Cash Flow |
| 25.00K | 12.04M | 3.47M | -507.00K | 41.51M | 16.96M |
Talphera Technical Analysis
Negative
0.50
Price Trends
0.53
Negative
0.57
Negative
0.71
Negative
Market Momentum
>-0.01
Negative
45.77
Neutral
41.18
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 0.5 is below the 20-day moving average (MA) of 0.51, below the 50-day MA of 0.53, and below the 200-day MA of 0.71, indicating a bearish trend. The MACD of >-0.01 indicates Negative momentum. The RSI at 45.77 is Neutral, neither overbought nor oversold. The STOCH value of 41.18 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 (53)
Financial Indicators
Name | Overall Rating | Market Cap | P/E Ratio | ROE | Dividend Yield | Revenue Growth | EPS Growth |
|---|---|---|---|---|---|---|---|
53 Neutral | $5.14B | 3.06 | -43.57% | 2.81% | 16.81% | -0.12% | |
49 Neutral | $9.62M | ― | -52.79% | ― | 82.77% | -87.95% | |
49 Neutral | $8.85M | ― | -126.34% | ― | 3.87% | 35.37% | |
41 Neutral | $19.82M | ― | -160.26% | ― | ― | 19.21% | |
41 Neutral | $10.57M | ― | -106.83% | ― | -100.00% | 65.76% | |
31 Underperform | $12.70M | ― | -458.99% | ― | 34.74% | -53.67% | |
| $9.49M | ― | -59.91% | ― | ― | ― |
* Healthcare Sector Average
Performance Comparison
TLPH
Talphera
0.50
-0.54
-51.92%
RLMD
Relmada Therapeutics
0.62
-2.49
-80.06%
IMRN
Immuron
1.83
-0.48
-20.78%
MSPR
MSP Recovery
1.39
-16.25
-92.12%
INBS
Intelligent Bio Solutions
1.29
-1.01
-43.91%
NEUP
Neuphoria Therapeutics
6.23
-5.41
-46.48%
Talphera Earnings Call Summary
Earnings Call Date:May 14, 2025
(Q1-2025)
| % Change Since: -1.96%|
Next Earnings Date:Aug 18, 2025
Earnings Call Sentiment Positive
The call highlights significant progress in study adjustments and financial management, with strong engagement from new clinical sites. However, challenges with legacy site performance and patient enrollment were notable issues.Q1-2025 Updates
Positive Updates
FDA Approval for NEPHRO CRRT Trial Adjustments
The trial received FDA approval for a significantly decreased study size from 166 to 70 patients, removal of certain exclusion criteria, and activation of additional high-volume sites to accelerate enrollment.
Successful PIPE Financing
Completed a PIPE financing structured in three equal tranches of $4.925 million, with conditions that are expected to be achieved within the year.
Cost Reduction and Financial Management
Reduced cash operating expenses from $4.2 million in Q1 2024 to $2.9 million in Q1 2025, with further reductions in personnel expenses and other administrative costs.
High Engagement with New Clinical Sites
Added 3 new sites with 5 more expected by mid-year, all fitting the new target profile, enhancing engagement and efficiency in contracting.
Negative Updates
Legacy Sites Underperformance
The 4 legacy sites are not expected to contribute significantly to the study, with the majority of enrollment coming from new sites.
Challenges in Patient Enrollment
Despite broader enrollment criteria, legacy sites have not translated increased activity into new patient enrollments due to patient population characteristics.
Company Guidance
During the Talphera First Quarter 2025 Financial Results Conference Call, the company provided key guidance metrics, emphasizing a strategic focus on enhancing the NEPHRO CRRT trial. Notably, the trial size was reduced from 166 to 70 patients, and the company activated additional high-volume sites, which include 3 new sites with 5 more expected by mid-year, to expedite patient enrollment. Talphera also completed a PIPE financing, structured in three tranches, with a total commitment of $14.8 million contingent on enrollment milestones. Financially, the company reduced its cash operating expense guidance to a range of $17 million to $19 million for 2025, down from prior estimates, and reported a first-quarter cash balance of $5.4 million. These changes, alongside the potential compassionate use IDE discussions, are intended to support the completion of the study by year-end, with an FDA approval for Niyad anticipated in 2026.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.