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PolyPid Ltd. (PYPD)
NASDAQ:PYPD
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PolyPid
(NASDAQ:PYPD)
30Underperform
Positive Factors
Clinical Trials
The SHIELD II interim analysis clears a key hurdle with the DSMB recommending to conclude the study upon enrollment of 800 patients, indicating positive progress in the trial.
Regulatory Approval
D-PLEX has both Fast Track and Breakthrough Therapy Designation from the FDA, which suggests a high priority and potentially expedited review process.
Negative Factors
Financial Performance
The 12-month price target has been adjusted to $11 from $14 to account for the equity dilution resulting from the recent financing.
Market Opportunity
PolyPid anticipates a broad abdominal-surgery label, with the potential to be limited to large incisions.
PolyPid (PYPD) vs. S&P 500 (SPY)
Market Cap
$28.02M
Dividend YieldN/A
Average Volume (3M)13.22K
Price to Earnings (P/E)―
Beta (1Y)0.12
Revenue GrowthN/A
EPS Growth-85.67%
CountryUS
Employees57
SectorHealthcare
Sector Strength76
IndustryBiotechnology
Share Statistics
EPS (TTM)-4.98
Shares Outstanding10,190,904
10 Day Avg. Volume12,106
30 Day Avg. Volume13,219
Financial Highlights & Ratios
PEG RatioN/A
Price to Book (P/B)N/A
Price to Sales (P/S)N/A
Price to Cash Flow (P/CF)N/A
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
$12.00Price Target Upside378.09% Upside
Rating ConsensusStrong Buy
Number of Analyst Covering4
PolyPid Business Overview & Revenue Model
Company DescriptionPolyPid (PYPD) is a clinical-stage biopharmaceutical company developing innovative, locally administered therapies utilizing its proprietary PLEX technology. The company's focus is on the creation of extended-release drug formulations that aim to improve surgical outcomes by reducing infections and promoting better recovery. PolyPid operates primarily in the healthcare and pharmaceutical sectors, with its lead product candidate being D-PLEX100, designed to prevent surgical site infections.
How the Company Makes MoneyPolyPid makes money by advancing its proprietary drug delivery technology, PLEX, through various stages of clinical development with the aim of commercializing its products. The company seeks to generate revenue through licensing agreements, partnerships, and potential sales of its developed products upon regulatory approval. Key revenue streams include milestone payments from partnerships and collaborations with larger pharmaceutical companies, as well as future sales revenue from its flagship product, D-PLEX100, if it successfully receives market approval.
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
2.51
Price Trends
2.92
Negative
3.04
Negative
3.31
Negative
Market Momentum
-0.06
Positive
44.26
Neutral
20.71
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 2.51 is below the 20-day moving average (MA) of 2.82, below the 50-day MA of 2.92, and below the 200-day MA of 3.31, indicating a bearish trend. The MACD of -0.06 indicates Positive momentum. The RSI at 44.26 is Neutral, neither overbought nor oversold. The STOCH value of 20.71 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 (48)
Financial Indicators
Name | Overall Rating | Market Cap | P/E Ratio | ROE | Dividend Yield | Revenue Growth | EPS Growth |
|---|---|---|---|---|---|---|---|
56 Neutral | $4.56B | ― | -76.51% | ― | ― | -213.94% | |
52 Neutral | $1.43B | ― | 18.68% | ― | 36.00% | 63.50% | |
49 Neutral | $60.07M | ― | -16.66% | ― | -17.83% | 94.26% | |
48 Neutral | $6.36B | 1.09 | -49.92% | 2.63% | 17.17% | 0.95% | |
44 Neutral | $21.95M | ― | -270.01% | ― | -65.96% | 40.80% | |
42 Neutral | $28.26M | ― | 60.38% | ― | 5.59% | 83.59% | |
30 Underperform | $28.02M | ― | -1038.73% | ― | ― | -85.67% |
* Healthcare Sector Average
Performance Comparison
PYPD
PolyPid
2.51
-1.99
-44.22%
BCRX
BioCryst
6.83
2.22
48.16%
ASRT
Assertio Therapeutics
0.63
-0.29
-31.52%
CARA
Cara Therapeutics
4.80
-5.11
-51.56%
FGEN
FibroGen
0.28
-1.35
-82.82%
VRNA
Verona Pharma
53.90
37.02
219.31%
PolyPid Earnings Call Summary
Earnings Call Date: Feb 12, 2025 | % Change Since: -12.85% | Next Earnings Date: May 7, 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.Highlights
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.
Lowlights
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.