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PolyPid Ltd. (PYPD)
NASDAQ:PYPD
US Market

PolyPid (PYPD) AI Stock Analysis

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PYPD

PolyPid

(NASDAQ:PYPD)

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Neutral 56 (OpenAI - 5.2)
Rating:56Neutral
Price Target:
$4.50
▼(-3.23% Downside)
The score is held back primarily by weak financial fundamentals (no revenue, continued losses/cash burn, and financing risk). Offsetting this is a favorable earnings-call outlook with clear regulatory timelines and commercial readiness progress, while technicals show an uptrend but appear overbought. Valuation is difficult to anchor given negative earnings and no dividend.
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)

PolyPid Business Overview & Revenue Model

Company DescriptionPolyPid Ltd., a late-stage biopharma company, develops, manufactures, and commercializes products based on polymer-lipid encapsulation matrix (PLEX) platform to address unmet medical needs. Its lead product candidate is D-PLEX100, which is in Phase III clinical trial for the prevention of sternal (bone) surgical site infections (SSIs), as well as for the prevention of abdominal (soft tissue) SSIs. PolyPid Ltd. was incorporated in 2008 and is headquartered in Petah Tikva, Israel.
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.
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.
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.
BreakdownTTMDec 2024Dec 2023Dec 2022Dec 2021Dec 2020
Income Statement
Total Revenue0.000.000.000.000.000.00
Gross Profit0.000.000.00-1.72M-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 Assets15.37M25.22M15.37M25.97M44.23M75.85M
Cash, Cash Equivalents and Short-Term Investments5.61M15.64M5.61M12.59M32.20M44.48M
Total Debt11.78M9.62M11.78M13.73M0.000.00
Total Liabilities17.47M17.54M17.47M20.14M8.28M3.07M
Stockholders Equity-2.10M7.68M-2.10M5.83M35.96M72.78M
Cash Flow
Free Cash Flow0.00-22.04M-17.43M-36.08M-35.38M-22.77M
Operating Cash Flow0.00-21.96M-17.24M-34.32M-32.39M-21.60M
Investing Cash Flow0.00-330.00K3.80M16.57M36.90M-40.77M
Financing Cash Flow0.0032.42M9.98M16.43M1.03M62.77M

PolyPid Technical Analysis

Technical Analysis Sentiment
Positive
Last Price4.65
Price Trends
50DMA
3.93
Positive
100DMA
3.67
Positive
200DMA
3.39
Positive
Market Momentum
MACD
0.21
Negative
RSI
72.67
Negative
STOCH
85.80
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 4.65 is above the 20-day moving average (MA) of 4.18, above the 50-day MA of 3.93, and above the 200-day MA of 3.39, indicating a bullish trend. The MACD of 0.21 indicates Negative momentum. The RSI at 72.67 is Negative, neither overbought nor oversold. The STOCH value of 85.80 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

Overall Rating
UnderperformOutperform
Sector (51)
Financial Indicators
Name
Overall Rating
Market Cap
P/E Ratio
ROE
Dividend Yield
Revenue Growth
EPS Growth
56
Neutral
$73.92M-1.56-390.53%61.23%
52
Neutral
$24.85M-0.80-380.13%54.41%
51
Neutral
$7.86B-0.30-43.30%2.27%22.53%-2.21%
48
Neutral
$18.69M-0.24-54.40%18.73%
46
Neutral
$183.76M-1.25-21.16%-92.42%62.37%
* Healthcare Sector Average
Performance Comparison
Ticker
Company Name
Price
Change
% Change
PYPD
PolyPid
4.65
1.72
58.70%
CTXR
Citius Pharmaceuticals
0.90
-2.59
-74.21%
SABS
SAB Biotherapeutics
3.86
0.20
5.46%
LIMN
Liminatus Pharma
0.82
-10.54
-92.78%
TAOX
Tao Synergies
5.34
2.00
59.88%
APLM
Apollomics
22.52
11.68
107.75%

PolyPid Corporate Events

PolyPid Calls February 2026 Extraordinary Meeting to Approve Board Chair Compensation
Dec 31, 2025

On December 31, 2025, PolyPid Ltd. reported that it has convened an Extraordinary General Meeting of Shareholders to be held on February 4, 2026, at its Petach Tikva headquarters, with a single agenda item: approval of the compensation terms of Ms. Brooke Story, chair of the company’s board of directors. Shareholders of record at the close of business on January 5, 2026, will be entitled to receive notice and vote, either in person or by proxy, with the board recommending support for the proposed resolution, underscoring the company’s focus on formalizing board leadership compensation as part of its ongoing corporate governance framework.

The most recent analyst rating on (PYPD) stock is a Hold with a $4.50 price target. To see the full list of analyst forecasts on PolyPid stock, see the PYPD Stock Forecast page.

PolyPid Appoints Brooke Story as Chairman Amid Strategic Growth
Dec 16, 2025

PolyPid Ltd. announced the appointment of Brooke Story as Chairman of the Board of Directors, effective December 11, 2025. With over 25 years of MedTech leadership experience, including senior roles at Becton, Dickinson and Company and Medtronic PLC, Story’s expertise in surgical markets and corporate strategy is expected to enhance PolyPid’s strategic, commercial, and transaction capabilities. This appointment comes at a crucial time as PolyPid prepares for the New Drug Application submission of D-PLEX100, potentially transforming its clinical success into commercial reality and creating significant enterprise value.

The most recent analyst rating on (PYPD) stock is a Buy with a $9.00 price target. To see the full list of analyst forecasts on PolyPid stock, see the PYPD Stock Forecast page.

PolyPid Gains FDA Support for D-PLEX100 NDA Submission
Dec 3, 2025

On December 3, 2025, PolyPid announced receiving positive feedback from the FDA regarding its pre-NDA meeting for D-PLEX100, a product designed to prevent surgical site infections. The FDA’s agreement on the adequacy of PolyPid’s clinical data package, including successful Phase 3 trial results, supports the company’s plan to submit a rolling NDA in early 2026. This development validates PolyPid’s regulatory strategy and positions the company to potentially bring a transformative treatment to market, enhancing its standing in the biopharmaceutical industry.

The most recent analyst rating on (PYPD) stock is a Buy with a $9.00 price target. To see the full list of analyst forecasts on PolyPid stock, see the PYPD Stock Forecast page.

PolyPid Expands Share Offering to Strengthen Financial Position
Nov 26, 2025

On November 26, 2025, PolyPid Ltd. announced an increase in the maximum aggregate offering price of its ordinary shares from $8,250,000 to $15,000,000 under its Sales Agreement with Oppenheimer & Co. Inc. This strategic financial move is aimed at bolstering the company’s capital base, potentially enhancing its market position and providing additional resources to advance its business objectives.

The most recent analyst rating on (PYPD) stock is a Buy with a $9.00 price target. To see the full list of analyst forecasts on PolyPid stock, see the PYPD Stock Forecast page.

PolyPid Advances D-PLEX₁₀₀ Towards FDA Submission and Commercial Readiness
Nov 12, 2025

PolyPid Ltd. announced its third-quarter 2025 financial results and provided a corporate update, highlighting significant advancements in its regulatory strategy and commercial readiness for D-PLEX₁₀₀. The company is preparing for a pre-NDA meeting with the FDA in December and aims to submit an NDA in early 2026. Strategic partnership discussions in the U.S. have progressed following positive Phase 3 trial results. The company also completed a successful GMP inspection by the Israeli Ministry of Health, marking a key milestone towards commercial manufacturing readiness. Financially, PolyPid reported a net loss of $7.5 million for the quarter but reduced its long-term debt significantly, with cash reserves expected to support operations into 2026.

The most recent analyst rating on (PYPD) stock is a Buy with a $10.00 price target. To see the full list of analyst forecasts on PolyPid stock, see the PYPD Stock Forecast page.

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: Dec 30, 2025