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PolyPid Ltd. (PYPD)
NASDAQ:PYPD
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PolyPid
(NASDAQ:PYPD)
Rating:41Neutral
Price Target:―
Positive Factors
Financial Position
The company has strengthened its cash position through additional financing, extending operations into the third quarter of 2025.
Regulatory Support
D-PLEX100 has received Fast Track and Breakthrough designations, which supports a faster regulatory review process.
Trial Progress
The SHIELD II trial has successfully enrolled the initial target of 630 subjects, indicating strong trial progress.
Negative Factors
Regulatory Uncertainty
PolyPid management is preparing to engage for a pre-NDA meeting with the FDA to discuss a planned rolling NDA submission via D-PLEX100's Breakthrough Therapy designation.
Trial Size Increase
The DSMB's recommendation to increase the trial size to 800 subjects suggests a meaningful signal of benefit for D-PLEX100.
PolyPid (PYPD) vs. SPDR S&P 500 ETF (SPY)
Market Cap
$29.55M
Dividend YieldN/A
Average Volume (3M)24.54K
Price to Earnings (P/E)―
Beta (1Y)0.02
Revenue GrowthN/A
EPS Growth34.97%
CountryUS
Employees57
SectorHealthcare
Sector Strength43
IndustryBiotechnology
Share Statistics
EPS (TTM)-0.70
Shares Outstanding10,190,904
10 Day Avg. Volume44,222
30 Day Avg. Volume24,537
Financial Highlights & Ratios
PEG Ratio-0.01
Price to Book (P/B)1.91
Price to Sales (P/S)0.00
P/FCF Ratio0.00
Enterprise Value/Market CapN/A
Enterprise Value/RevenueN/A
Enterprise Value/Gross ProfitN/A
Enterprise Value/EbitdaN/A
Forecast
1Y Price Target
$11.33Price Target Upside306.09% Upside
Rating ConsensusStrong Buy
Number of Analyst Covering4
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 Financial Statement Overview
Summary
PolyPid's financial health is concerning, with no revenue, consistent losses, negative equity, and reliance on external financing. These factors indicate significant financial instability and operational inefficiencies.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 | ||||
| Dec 2023 | Dec 2022 | Dec 2021 | Dec 2020 | Dec 2019 |
|---|---|---|---|---|
| Income Statement | Total Revenue | |||
| 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | Gross Profit |
| -1.82M | -1.72M | -1.12M | -1.01M | -947.00K | EBIT |
| -22.87M | -38.89M | -42.88M | -26.27M | -18.56M | EBITDA |
| -20.26M | -36.37M | -41.48M | -35.86M | -5.94M | Net Income Common Stockholders |
| -23.86M | -39.52M | -40.71M | -35.32M | 4.75M |
| Balance Sheet | Cash, Cash Equivalents and Short-Term Investments | |||
| 5.61M | 12.59M | 32.20M | 44.48M | 26.62M | Total Assets |
| 15.37M | 25.97M | 44.23M | 75.85M | 33.77M | Total Debt |
| 11.78M | 13.73M | 0.00 | 0.00 | 0.00 | Net Debt |
| 6.17M | 5.18M | -9.82M | -4.32M | -3.94M | Total Liabilities |
| 17.47M | 20.11M | 8.01M | 3.07M | 2.83M | Stockholders Equity |
| -2.10M | 5.86M | 36.23M | 72.78M | 30.93M |
| Cash Flow | Free Cash Flow | |||
| -17.43M | -36.08M | -35.38M | -22.77M | -18.24M | Operating Cash Flow |
| -17.24M | -34.32M | -32.39M | -21.60M | -17.36M | Investing Cash Flow |
| 3.80M | 16.57M | 36.90M | -40.77M | -23.56M | Financing Cash Flow |
| 9.98M | 16.43M | 1.03M | 62.77M | 37.65M |
PolyPid Technical Analysis
Negative
2.79
Price Trends
2.74
Positive
2.88
Negative
3.13
Negative
Market Momentum
0.03
Negative
50.92
Neutral
25.56
Neutral
Evaluating momentum and price trends is crucial in stock analysis to make informed investment decisions. For PYPD, the sentiment is Negative. The current price of 2.79 is above the 20-day moving average (MA) of 2.77, above the 50-day MA of 2.74, and below the 200-day MA of 3.13, indicating a neutral trend. The MACD of 0.03 indicates Negative momentum. The RSI at 50.92 is Neutral, neither overbought nor oversold. The STOCH value of 25.56 is Neutral, not indicating any strong overbought or oversold conditions. Overall, these indicators collectively point to a Negative 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 (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% | |
46 Neutral | $35.25M | ― | -1205.58% | ― | 203.23% | 13.57% | |
46 Neutral | $40.74M | ― | -22.89% | ― | ― | 75.74% | |
45 Neutral | $34.67M | ― | -60.44% | ― | -76.29% | ― | |
41 Neutral | $29.55M | ― | -853.05% | ― | ― | 34.97% | |
41 Neutral | $22.68M | ― | -79.46% | ― | -95.30% | -135.89% | |
41 Neutral | $19.16M | ― | -66.15% | ― | 43.03% | 81.75% |
* Healthcare Sector Average
Performance Comparison
PYPD
PolyPid
2.79
-1.74
-38.41%
PLUR
Pluri
4.50
-1.67
-27.07%
CLGN
Collplant Holdings
2.01
-4.21
-67.68%
GRCE
Grace Therapeutics
2.97
0.32
12.08%
VYNE
VYNE Therapeutics
1.00
-1.63
-61.98%
ALGS
Aligos Therapeutics
5.67
-9.33
-62.20%
PolyPid Earnings Call Summary
Earnings Call Date:May 14, 2025
(Q1-2025)
| % Change Since: 2.95%|
Next Earnings Date:Aug 06, 2025
Earnings Call Sentiment Neutral
The earnings call highlighted significant progress and positive indicators for D-PLEX100, with successful trial enrollment and strong market potential. However, financial challenges such as increased net loss and R&D expenses present notable concerns.Q1-2025 Updates
Positive Updates
Successful Conclusion of SHIELD 2 Enrollment
PolyPid successfully concluded enrollment of the SHIELD 2 Phase 3 trial assessing the efficacy of D-PLEX100 for preventing surgical site infections in abdominal colorectal surgery.
Positive Indicators for D-PLEX100
The independent Data Safety Monitoring Board recommended concluding the SHIELD 2 trial at 800 patients, suggesting positive efficacy signals from D-PLEX100.
Strong U.S. Market Potential for D-PLEX100
The total addressable market for D-PLEX100 in the U.S. is estimated at over 12 million surgeries annually, with 4.4 million being abdominal soft tissue surgeries.
Advanced Partnering Discussions
PolyPid is in advanced discussions with multiple potential partners for U.S. commercialization of D-PLEX100, with significant partnering interest.
Solid Financial Position
PolyPid has $8 million in cash and cash equivalents, sufficient to fund operations into the third quarter of 2025.
Negative Updates
Increased Net Loss
PolyPid reported a net loss of $8.3 million for the first quarter of 2025, compared to $6.4 million in the same period of 2024.
Rising Research and Development Expenses
R&D expenses increased to $6.1 million in Q1 2025 from $5.1 million in Q1 2024, driven by the ramp-up of the SHIELD 2 Phase 3 trial.
Uncertain Pricing Strategy for D-PLEX100
PolyPid has not finalized the pricing strategy for D-PLEX100, with current assumptions being refined based on pending top line data.
Company Guidance
During PolyPid's First Quarter 2025 earnings call, detailed guidance was provided regarding the anticipated progress of the company's flagship product, D-PLEX100. The management highlighted the successful enrollment of 800 patients in the SHIELD 2 Phase 3 trial, with top-line data expected by the end of June 2025. The company is preparing for potential New Drug Application (NDA) and Marketing Authorization Application (MAA) submissions in early 2026. Financially, PolyPid reported cash and cash equivalents of $8 million as of March 31, 2025, projecting a cash runway into the third quarter of 2025, supported by a $15 million financing round completed in December 2024. There is potential for an additional $27 million from warrant exercises. Research and development expenses increased to $6.1 million due to the ramp-up of the SHIELD 2 trial, contributing to a net loss of $8.3 million for the quarter. The company is also actively engaged in U.S. and European partnership discussions to support the commercialization of D-PLEX100, with a focus on securing a partner with a dedicated hospital product sales force.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.