tiprankstipranks
Trending News
More News >
Talphera (TLPH)
NASDAQ:TLPH

Talphera (TLPH) AI Stock Analysis

Compare
1,929 Followers

Top Page

TL

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
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 patients, from 166, which should allow the trial to complete faster and reduce potential total cash expenses.
Study Progress
Management's expectation to complete the study by the end of 2025 suggests confidence in the trial's progress and timeline.
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)

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:May 14, 2025
(Q1-2025)
|
% Change Since: -11.76%|
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.

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 Profit-1.88M0.00-4.89M-820.00K-935.00K-616.00K
EBITDA-11.50M-15.25M-9.84M-17.20M-30.83M-35.22M
Net Income-11.64M-13.00M-18.40M47.76M-35.10M-40.38M
Balance Sheet
Total Assets18.24M18.24M20.39M47.49M77.89M66.30M
Cash, Cash Equivalents and Short-Term Investments8.86M8.86M9.38M15.77M46.63M42.89M
Total Debt0.000.000.005.36M18.62M25.60M
Total Liabilities10.23M10.23M6.29M25.67M113.79M122.05M
Stockholders Equity8.00M8.00M14.11M21.81M-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 Flow6.51M3.78M-528.00K36.45M-26.12M34.14M
Financing Cash Flow25.00K12.04M3.47M-507.00K41.51M16.96M

Talphera Technical Analysis

Technical Analysis Sentiment
Negative
Last Price0.45
Price Trends
50DMA
0.49
Negative
100DMA
0.53
Negative
200DMA
0.64
Negative
Market Momentum
MACD
-0.01
Positive
RSI
41.38
Neutral
STOCH
27.49
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 0.45 is below the 20-day moving average (MA) of 0.48, below the 50-day MA of 0.49, and below the 200-day MA of 0.64, indicating a bearish trend. The MACD of -0.01 indicates Positive momentum. The RSI at 41.38 is Neutral, neither overbought nor oversold. The STOCH value of 27.49 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 (55)
Financial Indicators
Name
Overall Rating
Market Cap
P/E Ratio
ROE
Dividend Yield
Revenue Growth
EPS Growth
62
Neutral
$12.65M-126.34%3.87%91.76%
55
Neutral
€4.87B18.24-49.50%1.94%13.92%-4.82%
49
Neutral
$9.83M-52.79%82.77%-87.95%
41
Neutral
$20.91M-160.26%19.21%
41
Neutral
$9.25M-106.83%-100.00%65.76%
39
Underperform
$8.90M-458.99%34.74%-53.67%
$13.20M-59.91%
* Healthcare Sector Average
Performance Comparison
Ticker
Company Name
Price
Change
% Change
TLPH
Talphera
0.45
-0.45
-50.00%
RLMD
Relmada Therapeutics
0.63
-2.56
-80.25%
IMRN
Immuron
1.78
-0.32
-15.24%
MSPR
MSP Recovery
1.02
-8.95
-89.77%
INBS
Intelligent Bio Solutions
1.83
0.05
2.81%
NEUP
Neuphoria Therapeutics
7.13
-1.15
-13.89%
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