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PolyPid
(NASDAQ:PYPD)
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Rating:56Neutral
Price Target:
$4.50
▲(15.38% Upside)
Action:Reiterated
Date:12/30/25
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.
Negative Factors
Consistent Financial Losses
Ongoing financial losses highlight challenges in achieving profitability, which could impact long-term sustainability and require continued external financing.
Read all positive and negative factors
Positive Factors
Negative 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.
Read all positive factors
PolyPid (PYPD) vs. SPDR S&P 500 ETF (SPY)
Market Cap
$81.87M
Dividend YieldN/A
Average Volume (3M)72.46K
Price to Earnings (P/E)―
Beta (1Y)0.72
Revenue GrowthN/A
EPS Growth55.59%
CountryUS
Employees72
SectorHealthcare
Sector Strength45
IndustryBiotechnology
Share Statistics
EPS (TTM)-1.91
Shares Outstanding19,083,237
10 Day Avg. Volume44,210
30 Day Avg. Volume72,461
Financial Highlights & Ratios
PEG Ratio0.04
Price to Book (P/B)6.47
Price to Sales (P/S)0.00
P/FCF Ratio0.00
Enterprise Value/Market Cap<0.01
Enterprise Value/RevenueN/A
Enterprise Value/Gross ProfitN/A
Enterprise Value/Ebitda>-0.01
Forecast
1Y Price Target
$11.33Price Target Upside190.60% Upside
Rating ConsensusStrong Buy
Number of Analyst Covering3
EPS Forecast (FY)-1.73
Revenue Forecast (FY)N/A
PolyPid Business Overview & Revenue Model
Company Description
PolyPid Ltd. is an advanced-stage biopharmaceutical company specializing in the development, manufacturing, and commercialization of therapeutic solutions. These solutions are based on its proprietary polymer-lipid encapsulation matrix (PLEX) plat...
How the Company Makes Money
null...
PolyPid Earnings Call Summary
Earnings Call Date:May 13, 2026
(Q1-2026)
| % Change Since: |
Next Earnings Date:Aug 12, 2026
Earnings Call Sentiment Positive
The call conveyed substantial forward momentum: a rolling NDA is underway with Fast Track/Breakthrough designations, strong SHIELD II efficacy and ~30-day PK data, manufacturing and inspection preparedness, late-stage U.S. partnership discussions, progress on a planned EU MAA, and elimination of outstanding loan liabilities. Major risks highlighted include a limited cash runway into H2 2026, the NDA not yet fully complete or accepted, dependence on a not-yet-finalized commercial partner, and uncertainty around FDA inspection timing (partly due to geopolitical factors). Overall, the company presented multiple near-term value-driving milestones balanced by execution and funding risks.Positive Updates
Rolling NDA Submission Initiated
PolyPid initiated a rolling NDA submission to the FDA on March 30, 2026; CMC and nonclinical modules plus administrative modules were submitted and the clinical module is expected imminently, completing the full NDA filing.
Negative Updates
Limited Cash Balance and Short Runway
Cash, cash equivalents and short-term deposits were $10.9 million as of March 31, 2026, down from $12.9 million at December 31, 2025 (≈-15.5%), with management stating current cash resources are expected to fund operations into the second half of 2026 only.
Read all updates
Q1-2026 Updates
Positive
Negative
Rolling NDA Submission Initiated
PolyPid initiated a rolling NDA submission to the FDA on March 30, 2026; CMC and nonclinical modules plus administrative modules were submitted and the clinical module is expected imminently, completing the full NDA filing.
Read all positive updates
Company Guidance
Management's guidance focused on near‑term regulatory and commercial milestones: PolyPid initiated a rolling NDA on March 30, 2026 (CMC, nonclinical and administrative modules filed; clinical module expected imminently), and—given Fast Track and Breakthrough Therapy designations—could qualify for priority review that shortens a standard 10‑month review to ~6 months once the FDA accepts the filing and conducts a pre‑approval inspection of a facility that has passed four consecutive GMP inspections and multiple mock audits; they also received a ~$4.3M PDUFA small‑business fee waiver. Financially, cash and equivalents were $10.9M at 3/31/26 (down from $12.9M at 12/31/25), the company repaid its loan in early May 2026, and management expects existing resources to fund operations into the second half of 2026 and through several near‑term milestones. Commercially, late‑stage U.S. partnership talks aim for a Q1 2027 launch, EMA meetings with Rapporteur/Co‑Rapporteur are scheduled this quarter with an MAA planned in Q3 2026, and clinical/commercial data points highlighted include a 64% relative risk reduction in severe wound events (P=0.0103) from SHIELD II and PK data showing ~30‑day sustained doxycycline release—aligning with the 30‑day Medicare TEAM accountability window.PolyPid Financial Statement Overview
Summary
Income Statement
18
Very Negative
Balance Sheet
32
Negative
Cash Flow
22
Negative
| Breakdown | TTM | Dec 2025 | Dec 2024 | Dec 2023 | Dec 2022 | Dec 2021 |
|---|---|---|---|---|---|---|
Income Statement | ||||||
| Total Revenue | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 |
| Gross Profit | 0.00 | 0.00 | 0.00 | 0.00 | -1.72M | -1.12M |
| EBITDA | -32.68M | -31.86M | -25.83M | -20.26M | -36.37M | -41.48M |
| Net Income | -33.63M | -34.17M | -29.02M | -23.86M | -39.52M | -40.71M |
Balance Sheet | ||||||
| Total Assets | 19.16M | 22.31M | 25.22M | 15.37M | 25.97M | 44.23M |
| Cash, Cash Equivalents and Short-Term Investments | 11.10M | 12.93M | 15.64M | 5.61M | 12.59M | 32.20M |
| Total Debt | 2.34M | 2.80M | 9.62M | 11.78M | 13.73M | 0.00 |
| Total Liabilities | 10.38M | 11.33M | 17.54M | 17.47M | 20.14M | 8.28M |
| Stockholders Equity | 8.78M | 10.97M | 7.68M | -2.10M | 5.83M | 35.96M |
Cash Flow | ||||||
| Free Cash Flow | 0.00 | 0.00 | -22.04M | -17.43M | -36.08M | -35.38M |
| Operating Cash Flow | 0.00 | 0.00 | -21.96M | -17.24M | -34.32M | -32.39M |
| Investing Cash Flow | 0.00 | 0.00 | -330.00K | 3.80M | 16.57M | 36.90M |
| Financing Cash Flow | 0.00 | 0.00 | 32.42M | 9.98M | 16.43M | 1.03M |
PolyPid Technical Analysis
Positive
3.90
Price Trends
4.73
Positive
4.60
Positive
4.36
Positive
Market Momentum
-0.11
Negative
54.26
Neutral
89.34
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 3.9 is below the 20-day moving average (MA) of 4.56, below the 50-day MA of 4.73, and below the 200-day MA of 4.36, indicating a bullish trend. The MACD of -0.11 indicates Negative momentum. The RSI at 54.26 is Neutral, neither overbought nor oversold. The STOCH value of 89.34 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 |
|---|---|---|---|---|---|---|---|
56 Neutral | $81.87M | -2.25 | -241.96% | ― | ― | 55.59% | |
54 Neutral | $15.65M | -0.22 | -67.42% | ― | ― | 55.15% | |
53 Neutral | $272.98M | 8.30 | -0.29% | ― | -100.00% | 72.96% | |
53 Neutral | $37.87M | -2.28 | 288.40% | ― | ― | 86.10% | |
51 Neutral | $7.86B | -0.30 | -43.30% | 2.27% | 22.53% | -2.21% |
* Healthcare Sector Average
PYPD
PolyPid
4.81
1.60
49.84%
CTXR
Citius Pharmaceuticals
0.64
-0.65
-50.23%
SABS
SAB Biotherapeutics
3.85
1.62
72.65%
LIMN
Liminatus Pharma
0.10
-4.73
-97.97%
TAOX
Tao Synergies
3.44
-2.51
-42.18%
APLM
Apollomics
17.00
11.42
204.66%
PolyPid Corporate Events
PolyPid Wins FDA Priority Review for D-PLEX100 NDA, Accelerating Path to Market
Jul 29, 2026
On July 29, 2026, PolyPid announced that the U.S. Food and Drug Administration accepted for filing its New Drug Application for D-PLEX100 and granted Priority Review for use in preventing surgical site infections in abdominal colorectal surgery pa...
PolyPid Strikes Azurity Commercialization Deal for D-PLEX100 in U.S. and Canada
Jul 21, 2026
On July 17, 2026, PolyPid entered into an exclusive license and supply agreement with Azurity Pharmaceuticals for commercialization of D-PLEX100 in the U.S. and Canada for the prevention of surgical site infections. The deal includes $15 million u...
PolyPid Sets July 15, 2026 Shareholder Meeting to Vote on Board, Auditor and Equity Grants
Jun 10, 2026
PolyPid has called an annual and extraordinary general meeting of shareholders for July 15, 2026, in Petach Tikva, Israel, with a June 15, 2026 record date determining voting eligibility. The Form 6-K filing dated June 10, 2026, also incorporates ...
PolyPid Files NDA with FDA for Lead Infection-Prevention Drug D-PLEX100
Jun 1, 2026
On June 1, 2026, PolyPid announced it had completed a rolling New Drug Application submission to the U.S. Food and Drug Administration for D-PLEX100, its lead candidate for preventing surgical site infections in colorectal surgery patients. The fi...
PolyPid Advances D-PLEX₁₀₀ Toward FDA Review as Q1 2026 Loss Narrows and Debt Is Retired
May 13, 2026
On May 13, 2026, PolyPid reported first-quarter 2026 results and a major regulatory milestone, having initiated a rolling New Drug Application submission to the U.S. FDA on March 30, 2026 for D-PLEX₁₀₀ to prevent surgical site in...
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.