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PolyPid Ltd. (PYPD)
:PYPD
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PolyPid
(NASDAQ:PYPD)
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Rating:41Neutral
Price Target:―
PolyPid's score reflects significant financial challenges, including consistent losses and negative equity. While the company's clinical advancements and financing efforts are promising, they are not sufficient to offset the financial risks. The stock exhibits neutral technical indicators and an unattractive valuation, limiting its appeal to investors.
Positive Factors
Clinical Trial Progress
The positive recommendation from the DSMB indicates promising efficacy signals for D-PLEX100, enhancing its potential for regulatory approval and commercialization.
Financing and Cash Runway
The successful financing extends operational runway, providing financial stability to advance clinical trials and regulatory activities.
Market Potential for D-PLEX100
The large addressable market for D-PLEX100 in surgical procedures offers significant revenue potential upon successful commercialization and approval.
Negative Factors
Consistent Financial Losses
Ongoing financial losses highlight challenges in achieving profitability, which could impact long-term sustainability and require continued external financing.
Negative Equity
Negative equity suggests solvency issues, limiting financial flexibility and increasing reliance on external funding to support operations.
Increased R&D Expenses
Rising R&D costs, while necessary for product development, exacerbate financial strain and may delay the path to profitability if not managed effectively.
PolyPid (PYPD) vs. SPDR S&P 500 ETF (SPY)
Market Cap
$62.80M
Dividend YieldN/A
Average Volume (3M)77.22K
Price to Earnings (P/E)―
Beta (1Y)0.06
Revenue GrowthN/A
EPS Growth61.23%
CountryUS
Employees57
SectorHealthcare
Sector Strength45
IndustryBiotechnology
Share Statistics
EPS (TTM)-0.37
Shares Outstanding15,897,201
10 Day Avg. Volume48,560
30 Day Avg. Volume77,220
Financial Highlights & Ratios
PEG Ratio<0.01
Price to Book (P/B)2.34
Price to Sales (P/S)0.00
P/FCF Ratio-0.82
Enterprise Value/Market Cap0.83
Enterprise Value/RevenueN/A
Enterprise Value/Gross ProfitN/A
Enterprise Value/Ebitda-2.30
Forecast
1Y Price Target
$11.00Price Target Upside205.56% Upside
Rating ConsensusStrong Buy
Number of Analyst Covering3
EPS Forecast (FY)-2.21
Revenue Forecast (FY)N/A
PolyPid Business Overview & Revenue Model
Company DescriptionPolyPid Ltd. is a clinical-stage biopharmaceutical company focused on developing, manufacturing, and commercializing novel, locally administered therapies to improve surgical outcomes. The company operates predominantly in the healthcare sector, specializing in products that provide controlled and extended release of medications at surgical sites. PolyPid's core product candidate, D-PLEX100, is designed to deliver antibiotics directly to targeted areas to prevent surgical infections.
How the Company Makes MoneyPolyPid generates revenue primarily through the development and commercialization of its proprietary PLEX technology, which facilitates the extended release of drugs at surgical sites. The company's revenue model is focused on advancing its product pipeline through clinical trials towards regulatory approval and subsequent commercialization. Revenue streams include potential sales of its lead product candidate D-PLEX100 upon approval, as well as future licensing and partnership deals with other pharmaceutical companies. These partnerships may involve co-development, marketing, and distribution agreements, enhancing PolyPid's market reach and revenue potential.
PolyPid Earnings Call Summary
Earnings Call Date:Nov 12, 2025
(Q3-2025)
| % Change Since: |
Next Earnings Date:Feb 11, 2026
Earnings Call Sentiment Positive
The earnings call for PolyPid Ltd.'s third quarter of 2025 highlighted significant progress towards regulatory approval and commercial readiness for DPLEX 100, with strong validation from market studies and reduced financial losses. However, increased administrative and marketing expenses posed challenges. Overall, the positive aspects considerably outweigh the negatives.Q3-2025 Updates
Positive Updates
Successful Pre-NDA and European Readiness
PolyPid Ltd. is on track with its pre-NDA meeting scheduled for early December with the FDA and plans to submit the NDA for DPLEX 100 in early 2026, leveraging Fast Track and Breakthrough Therapy designations. The company is also preparing for the submission of the European Marketing Authorization Application following the NDA.
Positive Phase III Trial Results
The SHIELD II trial demonstrated a 58% reduction in surgical site infections with DPLEX 100, resulting in strong interest from surgeons and pharmacy directors and indicating significant commercial potential.
Financial Performance Improvements
PolyPid Ltd. reported a reduced net loss of $7.5 million for the quarter, compared to $7.8 million in the prior year, and increased cash reserves to $18.8 million, up from $15.6 million at year-end 2024.
Market Access Study Validation
A new US market study confirmed strong interest in DPLEX 100 from surgeons and hospital pharmacy directors, with 80% of surgeons likely to use it for eligible patients and 70% of pharmacy directors likely to add it to the formulary.
Negative Updates
Increased General and Administrative Expenses
General and administrative expenses rose to $1.8 million from $1.2 million in the third quarter of 2024, impacting overall financial performance.
Higher Marketing and Business Development Costs
Marketing and business development expenses increased to $400,000 from $200,000 in the same period last year, contributing to the overall rise in operational expenses.
Company Guidance
During PolyPid Ltd.'s third quarter 2025 conference call, the company provided detailed guidance on its strategic initiatives, focusing on regulatory, commercial, and manufacturing readiness for its late-stage product candidate, DPLEX 100. Key metrics highlighted include the scheduled pre-NDA meeting with the FDA in early December, the anticipated NDA submission in early 2026, and ongoing preparations for the European Marketing Authorization Application. The company also reported a successful GMP inspection by the Israeli Ministry of Health, marking its fourth consecutive positive assessment, which supports commercial manufacturing readiness for both the European and potential upcoming FDA inspections. Financially, PolyPid Ltd. reported a net loss of $7.5 million for the quarter, with research and development expenses totaling $5.3 million. Cash reserves stood at $18.8 million, expected to fund operations well into 2026. The company continues advancing US partnership discussions and completed a market study highlighting strong commercial potential for DPLEX 100, with 80% of surveyed surgeons likely to use it post-launch and 70% of pharmacy directors indicating a high likelihood of adding it to their formulary.PolyPid Financial Statement Overview
Summary
PolyPid's financial health is concerning with no revenue generation, consistent losses, and negative equity. The company is highly reliant on external financing to maintain operations, which poses a risk to sustainability.Income Statement
PolyPid has consistently reported no revenue over the past five years, indicating challenges in commercializing its products. The gross and net profit margins are negative, reflecting significant losses. EBIT and EBITDA margins are also unfavorable, suggesting ongoing operational inefficiencies.10
Very Negative
Balance Sheet
The company exhibits a concerning financial structure with negative stockholders' equity in the latest year, indicating that liabilities exceed assets. The debt-to-equity ratio is not applicable due to negative equity, but the overall high level of debt relative to assets suggests potential solvency issues.15
Very Negative
Cash Flow
PolyPid's cash flow shows negative operating cash flow and free cash flow, indicating insufficient cash generation from operations. This trend persists over the years, albeit with some improvement in recent years. However, reliance on financing activities to support cash needs poses a risk.20
Very Negative
| Breakdown | TTM | Dec 2024 | Dec 2023 | Dec 2022 | Dec 2021 | Dec 2020 |
|---|---|---|---|---|---|---|
Income Statement | ||||||
| Total Revenue | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 |
| Gross Profit | 0.00 | 0.00 | 0.00 | -1.72M | -1.12M | -1.01M |
| EBITDA | -22.74M | -26.41M | -21.05M | -36.37M | -41.48M | -35.86M |
| Net Income | -23.86M | -29.02M | -23.86M | -39.52M | -40.71M | -35.32M |
Balance Sheet | ||||||
| Total Assets | 15.37M | 25.22M | 15.37M | 25.97M | 44.23M | 75.85M |
| Cash, Cash Equivalents and Short-Term Investments | 5.61M | 15.64M | 5.61M | 12.59M | 32.20M | 44.48M |
| Total Debt | 11.78M | 9.62M | 11.78M | 13.73M | 0.00 | 0.00 |
| Total Liabilities | 17.47M | 17.54M | 17.47M | 20.14M | 8.28M | 3.07M |
| Stockholders Equity | -2.10M | 7.68M | -2.10M | 5.83M | 35.96M | 72.78M |
Cash Flow | ||||||
| Free Cash Flow | 0.00 | -22.04M | -17.43M | -36.08M | -35.38M | -22.77M |
| Operating Cash Flow | 0.00 | -21.96M | -17.24M | -34.32M | -32.39M | -21.60M |
| Investing Cash Flow | 0.00 | -330.00K | 3.80M | 16.57M | 36.90M | -40.77M |
| Financing Cash Flow | 0.00 | 32.42M | 9.98M | 16.43M | 1.03M | 62.77M |
PolyPid Technical Analysis
Positive
3.60
Price Trends
3.53
Positive
3.50
Positive
3.23
Positive
Market Momentum
0.06
Negative
67.82
Neutral
86.02
Negative
Evaluating momentum and price trends is crucial in stock analysis to make informed investment decisions. For PYPD, the sentiment is Positive. The current price of 3.6 is below the 20-day moving average (MA) of 3.71, above the 50-day MA of 3.53, and above the 200-day MA of 3.23, indicating a bullish trend. The MACD of 0.06 indicates Negative momentum. The RSI at 67.82 is Neutral, neither overbought nor oversold. The STOCH value of 86.02 is Negative, not indicating any strong overbought or oversold conditions. Overall, these indicators collectively point to a Positive sentiment for PYPD.
PolyPid Risk Analysis
PolyPid disclosed 78 risk factors in its most recent earnings report. PolyPid 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
PolyPid Peers Comparison
UnderperformOutperform
Sector (51)
Name | Overall Rating | Market Cap | P/E Ratio | ROE | Dividend Yield | Revenue Growth | EPS Growth |
|---|---|---|---|---|---|---|---|
52 Neutral | $33.84M | -0.81 | -21.16% | ― | -92.42% | 62.37% | |
51 Neutral | $7.86B | -0.30 | -43.30% | 2.27% | 22.53% | -2.21% | |
44 Neutral | $15.28M | -0.25 | ― | ― | ― | 80.54% | |
41 Neutral | $62.80M | ― | -390.53% | ― | ― | 61.23% | |
38 Underperform | $26.60M | ― | -53.42% | ― | ― | 18.73% |
* Healthcare Sector Average
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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.