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On Monday, H.C. Wainwright research firm reaffirmed a Buy rating and a $11.00 price target for PolyPid Ltd. (NASDAQ:PYPD), representing potential upside of over 340% from the current price of $2.48, following the company’s recent announcement regarding its SHIELD II Phase 3 trial. According to InvestingPro data, analyst targets range from $10 to $13, with the company currently valued at $25.3 million. The trial, which focuses on D-PLEX100 for the prevention of surgical site infections in abdominal colorectal surgery patients, has successfully completed enrollment.
PolyPid reported last month that the independent Data Safety Monitoring Board (DSMB) had analyzed unblinded efficacy data from the first 430 patients. Based on this analysis, the DSMB recommended concluding the study after enrolling 800 patients—the lowest sample size reassessment stop after the minimum planned number of patients was met. The interim analysis gave the DSMB several options, including stopping the trial for futility or overwhelming efficacy or adjusting the sample size up to 1,100 patients. The decision to proceed with the lowest number of patients represents a base case scenario.
The company expects to share the top-line results from the trial by the end of the second quarter of 2025, with its next earnings report due on May 7, 2025. If the Phase 3 data are positive, PolyPid plans to submit a New Drug Application (NDA) to the FDA. For deeper insights into PolyPid’s financial health and growth prospects, including 8 additional ProTips and comprehensive analysis, check out the full research report on InvestingPro. The application will benefit from Fast Track and Breakthrough Therapy designations, which could allow for a Priority Review. This expedited process could lead to an assessment within six months, with a possible approval decision by mid-2026.
H.C. Wainwright analysts have projected a U.S. launch for D-PLEX100 by the end of 2026, contingent on favorable trial outcomes and regulatory approval. The firm’s reiterated Buy rating and price target reflect anticipation of positive results from the SHIELD II trial in the upcoming months. Based on InvestingPro’s Fair Value analysis, the stock appears to be trading near its fair value, with an overall financial health score of 1.71, rated as "WEAK" due to current unprofitability and negative cash flows.
In other recent news, PolyPid reported a widening net loss for the fourth quarter of 2024, with figures reaching $8.5 million compared to $6.4 million in the same period the previous year. The company has been investing heavily in its DPLEX-100 Phase III SHIELD-II trial, which aims to prevent surgical site infections, leading to an increase in research and development expenses to $7 million from $4.6 million. PolyPid’s financial position was strengthened by $14.5 million in private placement financing, bolstering its cash reserves to $15.6 million as of December 31, 2024. Looking ahead, the company plans to complete the enrollment for its SHIELD-II trial by March 2025, with top-line results expected in the second quarter of 2025. The company is also preparing for a potential New Drug Application (NDA) submission, contingent on positive trial outcomes. PolyPid is exploring partnership opportunities to enhance its market presence in the U.S. and globally. CEO Dikla Chachkis Axelrad expressed optimism about the SHIELD II trial’s progress, viewing the DSMB’s recommendation to conclude the trial upon the enrollment of 800 patients as a favorable outcome.
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