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PolyPid
(NASDAQ:PYPD)
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Rating:56Neutral
Price Target:
$4.50
▼(-11.94% Downside)
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
$97.32M
Dividend YieldN/A
Average Volume (3M)72.46K
Price to Earnings (P/E)―
Beta (1Y)0.70
Revenue GrowthN/A
EPS Growth61.30%
CountryUS
Employees72
SectorHealthcare
Sector Strength45
IndustryBiotechnology
Share Statistics
EPS (TTM)-1.48
Shares Outstanding20,311,766
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
$11.00Price Target Upside115.26% 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:Aug 12, 2026
(Q2-2026)
| % Change Since: |
Next Earnings Date:Nov 11, 2026
Earnings Call Sentiment Positive
The call presented several transformative, near-term positive developments: NDA acceptance with Priority Review, a commercial partnership with Azurity that secured $30M upfront/near-term funding plus >$290M in contingent milestones and royalties, strong manufacturing readiness and planned EMA submission — all of which materially de-risk the program and improve the company's prospects. Key challenges include a low quarter-end cash balance prior to post-quarter receipts, continued operating losses, dependence on Azurity for commercial execution, and remaining regulatory/inspection risk. On balance, the substantial regulatory progress, firm commercial deal economics and subsequent cash inflows outweigh the operational and financial risks discussed on the call.Positive Updates
NDA Accepted for Filing with Priority Review and PDUFA Date
FDA accepted PolyPid's NDA for D-PLEX100 for prevention of surgical site infection and granted Priority Review, shortening review to 6 months and setting a PDUFA goal date of November 28, 2026. FDA identified no filing review issues on acceptance — a strong regulatory signal.
Negative Updates
Low Reported Cash at Quarter End (Pre-Deal Receipts)
Cash and cash equivalents were $6.6M as of June 30, 2026, down from $12.9M at Dec 31, 2025 (a decline of ~$6.3M, ~48.8%). Although subsequent $30.0M inflows were received post-quarter, the low quarter-end cash balance represented a significant near-term liquidity consideration until those receipts were realized.
Read all updates
Q2-2026 Updates
Positive
Negative
NDA Accepted for Filing with Priority Review and PDUFA Date
FDA accepted PolyPid's NDA for D-PLEX100 for prevention of surgical site infection and granted Priority Review, shortening review to 6 months and setting a PDUFA goal date of November 28, 2026. FDA identified no filing review issues on acceptance — a strong regulatory signal.
Read all positive updates
Company Guidance
Management's guidance centered on a clear near‑term regulatory and commercial timetable and quantified financial outlook: the FDA accepted the NDA and granted Priority Review (PDUFA goal date November 28, 2026; Priority Review shortens the standard ~10‑month review to ~6 months), PolyPid plans an EMA MAA submission in Q3 2026 and expects an Azurity commercial launch in the U.S. in early 2027, with an FDA pre‑approval inspection and ongoing mock inspections already underway and four prior successful GMP inspections (including Israeli MOH Sept 2025); financially, PolyPid has secured $30.0M of upfront/near‑term payments (including $15.0M at signing and $15.0M on FDA acceptance), is eligible for >$290.0M of additional regulatory/launch/sales milestones, will receive tiered royalties of mid‑teens to mid‑20s%, and will recognize transfer‑price revenue on every vial supplied (vial sales recognized at time of supply), had $6.6M cash as of June 30, 2026 (vs. $12.9M at Dec. 31, 2025) and received the $30.0M post‑quarter proceeds, has ~ $7.3M of warrants outstanding (expiring June 2027), reported Q2 R&D of $6.1M (vs. $6.2M prior year), G&A $1.3M (vs. $2.5M), marketing $0.5M (vs. $0.7M), Q2 net loss $7.8M or $0.35/share (vs. $10.0M or $0.78/share prior year; 6M net loss $15.6M vs. $18.2M), and expects existing cash plus partner proceeds to fund operations into 2028 with no immediate financing need; Azurity brings scale (access to ~1,700 hospitals, >200 U.S. commercial reps, ~1,000 employees worldwide, a portfolio of >50 medicines across 10 therapeutic areas) and will fund label‑expansion development and NTAP/reimbursement efforts (timing targets include October-related reimbursement deadlines).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 | -30.77M | -31.86M | -25.83M | -20.26M | -36.37M | -41.48M |
| Net Income | -31.50M | -34.17M | -29.02M | -23.86M | -39.52M | -40.71M |
Balance Sheet | ||||||
| Total Assets | 15.23M | 22.31M | 25.22M | 15.37M | 25.97M | 44.23M |
| Cash, Cash Equivalents and Short-Term Investments | 6.56M | 12.93M | 15.64M | 5.61M | 12.59M | 32.20M |
| Total Debt | 1.57M | 2.80M | 9.62M | 11.78M | 13.73M | 0.00 |
| Total Liabilities | 9.85M | 11.33M | 17.54M | 17.47M | 20.14M | 8.28M |
| Stockholders Equity | 5.39M | 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
5.11
Price Trends
4.80
Positive
4.69
Positive
4.46
Positive
Market Momentum
0.13
Negative
59.51
Neutral
83.23
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 5.11 is above the 20-day moving average (MA) of 4.81, above the 50-day MA of 4.80, and above the 200-day MA of 4.46, indicating a bullish trend. The MACD of 0.13 indicates Negative momentum. The RSI at 59.51 is Neutral, neither overbought nor oversold. The STOCH value of 83.23 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 | $97.32M | -3.45 | -311.07% | ― | ― | 61.30% | |
53 Neutral | $346.66M | 1.09 | -6.74% | ― | -100.00% | 95.16% | |
51 Neutral | $7.86B | -0.30 | -43.30% | 2.27% | 22.53% | -2.21% | |
51 Neutral | $58.20M | -3.46 | 288.40% | ― | ― | 86.10% | |
40 Underperform | $16.57M | -0.27 | -67.42% | ― | ― | 57.48% |
* Healthcare Sector Average
PYPD
PolyPid
5.11
1.73
51.18%
CTXR
Citius Pharmaceuticals
0.58
-0.82
-58.79%
SABS
SAB Biotherapeutics
3.88
1.78
84.76%
LIMN
Liminatus Pharma
4.41
-133.59
-96.80%
TAOX
Tao Synergies
3.99
-2.55
-38.99%
APLM
Apollomics
26.20
22.02
526.79%
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.