Polypid Ltd. Stock Price, News & Analysis

PolyPid Ltd. (Nasdaq: PYPD), a late-stage biopharma company, will present at the JMP Securities 2022 Life Sciences Conference in New York City on June 15-16, 2022. The presentation is scheduled for June 15 at 11:00 AM Eastern Time. PolyPid focuses on improving surgical outcomes through its proprietary PLEX technology, which allows controlled, prolonged release of therapeutics. The lead product candidate, D-PLEX100, is currently in Phase 3 trials targeting surgical site infections. For inquiries, investors can reach out to their JMP representatives.

PolyPid Ltd. (Nasdaq: PYPD) announced promising animal study results regarding its lead product candidate, OncoPLEX, presented at the ASCO 2022 Annual Meeting. The studies indicate that locally administered OncoPLEX, which employs the PLEX technology for extended release of docetaxel, significantly reduces local tumor recurrence compared to systemic chemotherapy. In the CT26 model, 75% of OncoPLEX-treated animals were tumor-free versus 25% for the control. Similarly, 80% of U-87 model animals treated with OncoPLEX were tumor-free compared to 30% with the control. The Company plans to initiate a Phase 1/2 study.

PolyPid Ltd. (PYPD) announced the completion of patient enrollment in the SHIELD I Phase 3 study of D-PLEX₁₀₀, aimed at preventing surgical site infections (SSIs) in abdominal surgery. Following an unblinded interim efficacy analysis, the Data Safety Monitoring Board recommended closing the study at 950 patients, the minimum target. Top-line results are expected by the end of Q3 2022, with potential NDA and MAA submissions planned for H1 2023, following a pre-NDA meeting with the FDA. This pivotal trial represents a significant milestone in PolyPid's development efforts.

PolyPid Ltd. (PYPD) announced the expected enrollment of its 950th patient in the SHIELD I Phase 3 study of D-PLEX₁₀₀ for preventing surgical site infections (SSIs) in abdominal surgeries. The independent Data Safety Monitoring Board recommended concluding enrollment after reviewing data from 750 patients. Top-line results are anticipated by Q3 2022, with potential NDA and MAA submissions targeted for H1 2023. SSIs pose a significant healthcare burden, costing the U.S. nearly $10 billion annually. Successful results could significantly impact surgical outcomes and market opportunities.

PolyPid Ltd. (PYPD) announced significant updates regarding its Phase 3 SHIELD I trial of D-PLEX100, with approximately 900 patients enrolled. An unblinded interim analysis is expected soon, which could lead to early trial adjustments. The company secured a $15 million non-dilutive term loan to enhance cash flow and support commercialization efforts for D-PLEX100. Financial results show a loss of $11.9 million for Q1 2022, up from $8.7 million year-over-year, as R&D expenses increased. Cash reserves are sufficient to sustain operations into Q2 2023.

PolyPid Ltd. (Nasdaq: PYPD) announced it will release its first quarter 2022 financial results on May 11, 2022, before U.S. market opening.

A conference call and webcast will follow at 8:30 AM ET to discuss the results and operational highlights.

PolyPid focuses on improving surgical outcomes with its proprietary PLEX technology, currently advancing its lead product D-PLEX100 in Phase 3 trials for preventing surgical site infections.

PolyPid Ltd. (Nasdaq: PYPD) announced the presentation of clinical data at the 13th European and Global CLINAM Summit for Nanomedicine, focusing on D-PLEX₁₀₀. The study demonstrated D-PLEX₁₀₀ as an effective surgical site infection prevention agent in colorectal surgery patients, limiting antimicrobial resistance (AMR) without increasing postoperative colonization by multi-drug resistant organisms. This emphasizes the potential of PolyPid's proprietary PLEX technology in enhancing surgical outcomes. The presentation will be accessible on their website after the summit.

PolyPid Ltd. (Nasdaq: PYPD) announced plans to present clinical data evaluating the addition of D-PLEX100 to standard infection prophylaxis in elective colorectal surgery. This presentation will occur at the Surgical Infection Society 2022 Annual Meeting on April 23-26, 2022. The study titled ‘Incisional microenvironments and reduction in SSIs in patients treated with a local doxycycline-eluting formulation’ will be led by Dr. Anthony Senagore. PolyPid aims to enhance surgical outcomes through its proprietary PLEX technology, with D-PLEX100 currently in Phase 3 trials.

PolyPid Ltd. (Nasdaq: PYPD) has secured a loan facility of up to $15 million with Kreos Capital to extend its cash runway into the second quarter of 2023. The funds will support commercialization efforts for D-PLEX100, aimed at preventing surgical site infections, as well as advancing the OncoPLEX development platform. The loan consists of three tranches, with specific conditions for release based on clinical trial results. The senior secured loan carries an interest rate of 9.25%, adjustable upon achieving certain milestones.