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PolyPid Ltd. (PYPD)
NASDAQ:PYPD
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PolyPid
(NASDAQ:PYPD)
41Neutral
Positive Factors
Clinical Trials
The completion of enrollment in the SHIELD II Phase 3 trial is seen as a significant milestone for PolyPid, indicating progress towards its goals.
Financial Position
The company's balance sheet strength is considered favorable, supported by a recent financing transaction that raised $14.5 million in gross proceeds.
Regulatory Pathway
If the Phase 3 data prove positive, PolyPid plans to submit a New Drug Application to the FDA, utilizing both Fast Track and Breakthrough Therapy designations, which could expedite the review process.
Negative Factors
Market Competition
PolyPid anticipates a broad abdominal-surgery label, with the potential to be limited to large incisions.
Market Trends
Post-COVID trends for SSIs have been a 3% increase according to the CDC.
PolyPid (PYPD) vs. S&P 500 (SPY)
Market Cap
$27.62M
Dividend YieldN/A
Average Volume (3M)14.41K
Price to Earnings (P/E)―
Beta (1Y)0.05
Revenue GrowthN/A
EPS Growth34.97%
CountryUS
Employees57
SectorHealthcare
Sector Strength46
IndustryBiotechnology
Share Statistics
EPS (TTM)-1.13
Shares Outstanding10,190,904
10 Day Avg. Volume22,088
30 Day Avg. Volume14,415
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 Upside309.03% 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
Positive
2.77
Price Trends
2.76
Positive
2.89
Negative
3.16
Negative
Market Momentum
0.01
Negative
52.30
Neutral
40.00
Neutral
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 2.77 is above the 20-day moving average (MA) of 2.70, above the 50-day MA of 2.76, and below the 200-day MA of 3.16, indicating a neutral trend. The MACD of 0.01 indicates Negative momentum. The RSI at 52.30 is Neutral, neither overbought nor oversold. The STOCH value of 40.00 is Neutral, 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 (52)
Financial Indicators
Name | Overall Rating | Market Cap | P/E Ratio | ROE | Dividend Yield | Revenue Growth | EPS Growth |
|---|---|---|---|---|---|---|---|
52 Neutral | $5.15B | 3.56 | -42.52% | 2.83% | 14.56% | -0.50% | |
46 Neutral | $37.31M | ― | -22.89% | ― | ― | 75.74% | |
43 Neutral | $20.53M | ― | -56.54% | ― | 18.16% | 86.65% | |
41 Neutral | $27.62M | ― | -1038.73% | ― | ― | 34.97% | |
41 Neutral | $22.11M | ― | -79.46% | ― | -95.30% | -135.89% | |
40 Underperform | $44.84M | ― | -1205.58% | ― | 89.92% | 21.39% | |
30 Underperform | $27.39M | ― | -60.44% | ― | -76.29% | ― |
* Healthcare Sector Average
Performance Comparison
PYPD
PolyPid
2.77
-1.70
-38.03%
PLUR
Pluri
5.75
-0.47
-7.56%
CLGN
Collplant Holdings
1.82
-4.74
-72.26%
GRCE
Grace Therapeutics
2.72
-0.04
-1.45%
VYNE
VYNE Therapeutics
1.30
-1.53
-54.06%
ALGS
Aligos Therapeutics
4.48
-12.64
-73.83%
PolyPid Earnings Call Summary
Earnings Call Date:Feb 12, 2025
(Q4-2024)
| % Change Since: -3.82%|
Next Earnings Date:May 14, 2025
Earnings Call Sentiment Positive
The earnings call presented positive developments, particularly regarding the SHIELD II trial's DSMB recommendation, successful financing, and partnership efforts, which suggest promising future prospects for D-PLEX100. However, increased expenses and net losses highlight ongoing financial challenges.Q4-2024 Updates
Positive Updates
DSMB Recommendation for SHIELD II Trial
The independent Data Safety Monitoring Board (DSMB) recommended concluding the SHIELD II Phase 3 trial upon the enrollment of 800 patients, suggesting positive efficacy signals from D-PLEX100 for the prevention of surgical site infections.
Successful Private Placement Financing
PolyPid entered into a securities purchase agreement for a private placement financing led by existing institutional shareholders, raising $14.5 million in gross proceeds, extending the company's cash runway into Q3 2025.
Partnership and Collaboration Efforts
PolyPid is in active discussions with potential partners for the commercialization of D-PLEX100, and announced a research and development collaboration with ImmunoGenesis to enhance treatment for solid tumors using PolyPid's technology.
Expansion Opportunities for D-PLEX100
Potential market for D-PLEX100 in the U.S. includes over 12 million surgeries per year, with opportunities in abdominal, gynecology, and urology procedures.
Financial Position and Prospects
PolyPid had cash and cash equivalents of $15.6 million as of December 31, 2024, and expects cash flow to be sufficient to fund operations into Q3 2025.
Negative Updates
Increased R&D Expenses
Research and development expenses increased to $7 million for Q4 2024 from $4.6 million in the same period in 2023, largely due to the SHIELD II Phase 3 trial.
Net Loss for Q4 and Full Year 2024
PolyPid reported a net loss of $8.5 million in Q4 2024 compared to $6.4 million in Q4 2023, and a net loss of $29 million for the full year 2024 compared to $23.9 million in 2023.
Company Guidance
During the PolyPid Fourth Quarter 2024 Conference Call, the company provided guidance on several key metrics and milestones. PolyPid is advancing its SHIELD II Phase 3 trial with D-PLEX100, a treatment aimed at preventing surgical site infections in abdominal colorectal surgeries. The trial, which has enrolled over 700 patients and expects to reach the 800-patient enrollment target by next month, is on track to report top-line results in Q2 2025. The company anticipates that, if successful, it will submit a New Drug Application (NDA) leveraging Fast Track and Breakthrough Therapy designations. PolyPid also completed a private placement financing of $14.5 million, extending its cash runway into Q3 2025. The exercise of associated warrants could yield an additional $27 million, potentially providing capital beyond NDA approval. Financially, PolyPid reported a net loss of $8.5 million for Q4 2024, an increase from $6.4 million in Q4 2023, with R&D expenses rising to $7 million for the quarter. The company continues to focus on regulatory preparations, potential partnerships, and exploring the market potential for D-PLEX100, which could address over 12 million surgeries annually in the U.S. alone.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.