PolyPid (PYPD) AI Stock Analysis

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PolyPid

(NASDAQ:PYPD)

41Neutral

PolyPid's score reflects significant financial challenges, including consistent losses and negative equity. While the company's clinical advancements and financing efforts are promising, they are not sufficient to offset the financial risks. The stock exhibits neutral technical indicators and an unattractive valuation, limiting its appeal to investors.

Positive Factors

Clinical Trials

The DSMB recommended the SHIELD II trial be upsized to 800 subjects, indicating a meaningful signal of benefit for D-PLEX100.

Financial Position

PolyPid's cash runway is extended through top-line pivotal results, expected to support operations into the third quarter of 2025.

Partnership Opportunities

The company is in active discussions with multiple potential commercial partners for D-PLEX100, with a focus on the U.S. opportunity.

Regulatory Process

D-PLEX100 has Fast Track and Breakthrough designations, with management planning to submit the NDA on a rolling basis.

Negative Factors

Stock Price Target

The 12-month price target has been adjusted to $11 from $14 to account for the equity dilution resulting from the recent financing.

PolyPid (PYPD) vs. S&P 500 (SPY)

Market Cap

$28.53M

Dividend YieldN/A

Average Volume (3M)13.81K

Price to Earnings (P/E)―

Beta (1Y)<0.01

Revenue GrowthN/A

EPS Growth34.97%

CountryUS

Employees57

SectorHealthcare

Sector Strength74

IndustryBiotechnology

Share Statistics

EPS (TTM)-4.98

Shares Outstanding10,190,904

10 Day Avg. Volume20,850

30 Day Avg. Volume13,814

Financial Highlights & Ratios

PEG RatioN/A

Price to Book (P/B)N/A

Price to Sales (P/S)0.00

Price to Cash Flow (P/CF)0.00

P/FCF Ratio0.00

Enterprise Value/Market Cap0.59

Enterprise Value/RevenueN/A

Enterprise Value/Gross Profit-9.18

Enterprise Value/EbitdaN/A

Forecast

1Y Price Target

$11.33

Price Target Upside297.54% 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

Very Negative

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.

Balance Sheet

Very Negative

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.

Cash Flow

Very Negative

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.

Dec 2023	Dec 2022	Dec 2021	Dec 2020	Dec 2019
Breakdown
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

Technical Analysis Sentiment

Positive

Last Price2.85

Price Trends

50DMA

2.79

Positive

100DMA

2.90

Negative

200DMA

3.19

Negative

Market Momentum

MACD

>-0.01

Negative

RSI

54.71

Neutral

STOCH

48.42

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 2.85 is above the 20-day moving average (MA) of 2.63, above the 50-day MA of 2.79, and below the 200-day MA of 3.19, indicating a neutral trend. The MACD of >-0.01 indicates Negative momentum. The RSI at 54.71 is Neutral, neither overbought nor oversold. The STOCH value of 48.42 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
Sector *	52 Neutral	$5.28B	3.75	-42.72%	2.86%	17.70%	2.03%
GRCE	46 Neutral	$37.18M	―	-22.89%	―	―	75.74%
VYNE	43 Neutral	$20.38M	―	-56.54%	―	18.16%	86.65%
PYPD	41 Neutral	$28.53M	―	-1038.73%	―	―	34.97%
CLGN	41 Neutral	$24.97M	―	-79.46%	―	-95.30%	-135.89%
PLUR	40 Underperform	$37.58M	―	-1205.58%	―	89.92%	21.39%
ALGS	30 Underperform	$36.90M	―	-415.84%	―	-74.60%	―

* Healthcare Sector Average

Performance Comparison

PYPD

PolyPid

2.80

-2.14

-43.32%

PLUR

Pluri

4.77

-0.98

-17.04%

CLGN

Collplant Holdings

2.18

-3.77

-63.36%

GRCE

Grace Therapeutics

2.71

-0.25

-8.45%

VYNE

VYNE Therapeutics

1.34

-1.28

-48.85%

ALGS

Aligos Therapeutics

6.04

-14.21

-70.17%

PolyPid Earnings Call Summary

Earnings Call Date:Feb 12, 2025

(Q4-2024)

% Change Since: -1.04%|

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.