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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)

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Neutral 49 (OpenAI - 5.2)
Rating:49Neutral
Price Target:
$1.50
▲(11.11% Upside)
Action:Reiterated
Date:07/11/26
The score is held down primarily by very weak financial performance (minimal recent revenue, large losses, and continued cash burn), even though leverage is currently low. Technicals show strong momentum but are overbought, which tempers the near-term setup. Earnings-call updates are constructive on clinical execution and timelines, but funding is partly contingent on conditional tranches, keeping risk meaningfully elevated.
Positive Factors
Low leverage / clean balance sheet
Zero reported debt and positive equity provide durable financial flexibility for a clinical-stage company. A clean balance sheet lowers refinancing pressure, supports negotiating leverage or partnerships, and reduces the probability that near-term development delays immediately force distressed financing choices.
Negative Factors
Persistent cash burn
Sustained negative operating and free cash flows create a structural funding requirement for continued development. Without durable revenue, the company must repeatedly access capital, which can be dilutive or costly, and raises the risk that clinical or timing hiccups force suboptimal financing choices.
Read all positive and negative factors
Positive Factors
Negative Factors
Low leverage / clean balance sheet
Zero reported debt and positive equity provide durable financial flexibility for a clinical-stage company. A clean balance sheet lowers refinancing pressure, supports negotiating leverage or partnerships, and reduces the probability that near-term development delays immediately force distressed financing choices.
Read all positive factors

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

Talphera Business Overview & Revenue Model

Company Description
Talphera, Inc. is a specialty pharmaceutical company focused on developing and commercializing therapeutic products intended for use in carefully monitored medical environments. Their lead experimental candidate is Niyad, a lyophilized (freeze-dri...
How the Company Makes Money
null...

Talphera Earnings Call Summary

Earnings Call Date:May 13, 2026
(Q1-2026)
|
% Change Since: |
Next Earnings Date:Aug 19, 2026
Earnings Call Sentiment Positive
The call conveyed strong clinical and operational momentum: enrollment has surpassed the 50% milestone, sites and KOLs reported favorable feedback on dosing simplicity and stability, and management expects a rapid top-line read in H2 2026 with a PMA plan for 2027. However, the company faces higher operating expenses and depends on two conditional financing tranches (~$16M) to fund the path to potential approval, with enrollment variability and financing contingency as primary risks. Overall, positive progress is balanced against execution and financing risk, but the highlights outweigh the lowlights.
Positive Updates
Enrollment Progress & Milestones
Achieved the 50% enrollment milestone in early March 2026 and have since "well exceeded" 50%; company expects to complete enrollment in 2026 and to file a PMA for Niyad in 2027. 9 of 12 activated sites aligned with the new target profile and have enrolled over 90% of patients to date.
Negative Updates
Increase in Operating Expenses
Cash operating expenses (R&D + SG&A) for Q1 2026 were $3.9M vs $2.9M in Q1 2025, an increase of $1.0M (+34.5%). Excluding non-cash stock-based compensation, cash operating expenses were $3.7M vs $2.7M, an increase of $1.0M (+37.0%). Management attributed the increase to higher Niyad development costs (driven by increased enrollment) and higher G&A.
Read all updates
Q1-2026 Updates
Negative
Enrollment Progress & Milestones
Achieved the 50% enrollment milestone in early March 2026 and have since "well exceeded" 50%; company expects to complete enrollment in 2026 and to file a PMA for Niyad in 2027. 9 of 12 activated sites aligned with the new target profile and have enrolled over 90% of patients to date.
Read all positive updates
Company Guidance
Management guided that Talphera expects to complete enrollment in the NEPHRO CRRT study in 2026, will announce last‑patient‑out and then top‑line data within about one month (guiding to a second‑half‑2026 readout), and is targeting a PMA filing for Niyad in 2027; they do not plan interim enrollment updates prior to LPO. Key financial metrics: cash of $21.1M at March 31, 2026, a $4.1M tranche closed in Q1 (from the March 2025 placement) and two remaining conditional tranches totaling ≈$16M expected to close around the topline data, which management believes, together with cash on hand, funds the company through a potential PMA approval next year; Q1 cash operating expenses (R&D + SG&A) were $3.9M vs $2.9M in Q1 2025 (or $3.7M vs $2.7M excluding non‑cash stock‑based compensation). Clinical metrics cited include having well exceeded the 50% enrollment milestone, 9 of 12 activated sites aligned with the new target profile that have enrolled >90% of patients, up to 14 FDA‑granted sites with two additional sites to be added, a 24‑hour primary endpoint (72‑hour secondary), and pharmacodynamic results showing ~70% of patients reach target ACT at first dose, ~25% require one titration and a few require two, with all in range by the end of the first hour.

Talphera Financial Statement Overview

Summary
Fundamentals are weak despite a currently clean capital structure: the income statement shows extremely low TTM revenue (~$1K) alongside a large net loss (~$14.3M), and cash flow remains deeply negative with TTM operating cash flow/free cash flow around -$11.3M (ongoing burn). The key offset is a balance sheet with $0 debt and positive equity (~$18.5M), but persistent losses and multi-year cash burn keep financial risk elevated.
Income Statement
12
Very Negative
Balance Sheet
58
Neutral
Cash Flow
18
Very Negative
BreakdownTTMDec 2025Mar 2025Dec 2023Dec 2022Dec 2021
Income Statement
Total Revenue1.00K28.00K0.00651.00K0.00378.00K
Gross Profit1.00K28.00K-6.72M-4.89M-1.65M-2.63M
EBITDA-14.25M-14.36M-12.51M-10.06M61.90M-12.88M
Net Income-14.25M-14.29M-13.00M-18.40M42.52M-35.10M
Balance Sheet
Total Assets30.16M29.72M18.24M20.39M47.49M77.89M
Cash, Cash Equivalents and Short-Term Investments21.11M20.38M8.86M9.38M15.77M46.63M
Total Debt0.006.50M6.53M0.0010.02M18.62M
Total Liabilities11.68M12.68M10.24M6.29M25.67M113.79M
Stockholders Equity18.48M17.04M8.00M14.11M21.81M-35.89M
Cash Flow
Free Cash Flow-11.29M-11.36M-12.68M-17.59M-28.70M-31.83M
Operating Cash Flow-11.29M-11.36M-12.68M-17.49M-28.33M-30.00M
Investing Cash Flow-17.06M-14.35M3.78M-528.00K36.45M-26.12M
Financing Cash Flow26.79M22.74M12.04M3.47M-507.00K41.51M

Talphera Technical Analysis

Technical Analysis Sentiment
Positive
Last Price1.35
Price Trends
50DMA
1.07
Positive
100DMA
0.94
Positive
200DMA
1.02
Positive
Market Momentum
MACD
0.06
Positive
RSI
53.41
Neutral
STOCH
46.03
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 1.35 is above the 20-day moving average (MA) of 1.32, above the 50-day MA of 1.07, and above the 200-day MA of 1.02, indicating a neutral trend. The MACD of 0.06 indicates Positive momentum. The RSI at 53.41 is Neutral, neither overbought nor oversold. The STOCH value of 46.03 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 45 risk factors in its most recent earnings report. Talphera reported the most risks in the "Tech & Innovation" 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
52
Neutral
$304.96M-16.21-0.07%12.19%1.97%
52
Neutral
$384.59M-8.74174.92%9.56%24.52%
52
Neutral
$175.40M-16.95-35.57%15.00%3.18%
51
Neutral
$7.86B-0.30-43.30%2.27%22.53%-2.21%
49
Neutral
$66.43M-3.56-92.98%-96.30%32.21%
49
Neutral
$1.40B-0.77-50.65%11.50%-3.62%-932.84%
45
Neutral
$5.27M-0.58-88.38%36.68%38.00%
* Healthcare Sector Average
Performance Comparison
Ticker
Company Name
Price
Change
% Change
TLPH
Talphera
1.28
0.88
217.62%
SNOA
Sonoma Pharmaceuticals
1.10
-1.98
-64.29%
PRGO
Perrigo Company
10.11
-14.73
-59.29%
ORGO
Organogenesis Holdings
2.37
-2.23
-48.48%
EOLS
Evolus
5.84
-3.27
-35.89%
DERM
Journey Medical Corp
6.37
-0.77
-10.78%

Talphera Corporate Events

Executive/Board ChangesShareholder Meetings
Talphera Shareholders Approve Directors and Governance Proposals
Positive
Jun 23, 2026
At its annual meeting held on June 22, 2026, Talphera shareholders elected Marina Bozilenko, Joseph Todisco and Mark Wan as Class III directors to serve until the 2029 annual meeting, while the remaining board members will continue in their curren...
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: Jul 11, 2026