PolyPid (NASDAQ:PYPD) Announces Quarterly Earnings Results

PolyPid (NASDAQ:PYPD) posted its quarterly earnings data on Wednesday. The company reported ($0.24) earnings per share (EPS) for the quarter, missing analysts’ consensus estimates of $0.91 by ($1.15), FiscalAI reports.

Here are the key takeaways from PolyPid’s conference call:

• FDA review is nearing a key decision: D-PLEX100’s priority-review PDUFA date is November 28, with labeling discussions underway and scheduled FDA interactions described as on track. Approval and the planned early-2027 launch remain subject to FDA action; the company did not discuss inspection details.
• PolyPid and Azurity are preparing for a U.S. launch, with Azurity building its commercial teams and targeting hospitals. The company cautioned that formulary reviews happen account by account and adoption may take several months; a CMS decision on NTAP reimbursement is expected in August 2027.
• Label expansion is a potential growth driver: PolyPid plans to begin FDA discussions this quarter on expanding D-PLEX100 beyond colorectal surgery to broader abdominal procedures. The company has not yet received FDA feedback on what evidence or requirements would be needed.
• The EMA validated PolyPid’s D-PLEX100 application and began its review, with a decision expected in the second half of 2027. After ending its European agreement with ADVANZ PHARMA, PolyPid regained commercialization rights and said it is discussing potential partnerships.
• PolyPid reported $15.5 million in cash and short-term deposits at quarter-end and said it received a further $15 million Azurity payment in early October; management expects resources to fund operations into 2028. The company also plans PD01B’s pre-IND meeting and first-in-human study in the second half of 2027, while the program remains in development.

PolyPid Price Performance

Shares of NASDAQ:PYPD traded up $0.33 during trading on Wednesday, reaching $6.64. 363,534 shares of the company’s stock traded hands, compared to its average volume of 125,962. The stock has a market capitalization of $126.69 million, a P/E ratio of -4.49 and a beta of 1.43. PolyPid has a 12 month low of $3.50 and a 12 month high of $7.15. The company has a 50 day moving average of $5.30 and a 200-day moving average of $4.77.

Wall Street Analysts Forecast Growth

Several brokerages have recently weighed in on PYPD. Weiss Ratings restated a “sell (d-)” rating on shares of PolyPid in a research note on Friday, September 18th. Wall Street Zen raised shares of PolyPid from a “hold” rating to a “buy” rating in a research note on Saturday, October 31st. Oppenheimer started coverage on shares of PolyPid in a report on Tuesday, October 27th. They issued an “outperform” rating and a $10.00 price objective on the stock. HC Wainwright reissued a “buy” rating and issued a $13.00 price objective on shares of PolyPid in a research report on Tuesday, July 21st. Finally, Craig Hallum set a $12.00 price objective on PolyPid in a report on Wednesday, July 22nd. Four equities research analysts have rated the stock with a Buy rating and one has issued a Sell rating to the stock. According to data from MarketBeat, PolyPid has an average rating of “Moderate Buy” and a consensus target price of $11.00.

About PolyPid

PolyPid Ltd. (NASDAQ: PYPD) is a clinical-stage biopharmaceutical company focused on developing locally administered therapies designed to provide controlled and sustained drug release at treatment sites. The company’s technology is intended to maintain therapeutic drug concentrations over extended periods while limiting systemic exposure. PolyPid’s lead product candidate is D-PLEX100, an investigational formulation based on doxycycline and the company’s proprietary PLEX polymeric matrix. It is being developed for the prevention of surgical-site infections, initially in patients undergoing colorectal surgery.