PolyPid Shares Corporate Update, Reports Q2 2024 Financial Results

PolyPid Ltd., a late-stage biopharma company focused on improving surgical outcomes, provided a corporate update and financial results for the quarter ending June 30, 2024. The company has made significant progress in its SHIELD II Phase 3 trial for D-PLEX100, a product aimed at preventing abdominal colorectal surgical site infections (SSIs).

As of now, about 320 patients have been enrolled in the SHIELD II trial, which targets patients undergoing colorectal abdominal surgery. An unblinded interim analysis will be conducted once 400 patients have completed their 30-day follow-up, expected in the fourth quarter of 2024. The top-line results are anticipated in the first quarter of 2025.

PolyPid recently closed a private placement financing with existing and new investors, generating $8.1 million in gross proceeds. This financing extends the company’s cash runway into the first quarter of 2025. Additionally, if the interim analysis results in either the stopping of the trial due to positive efficacy or continuation to planned patient recruitment, the company could secure another $6.1 million. Assuming all warrants issued in the financing are exercised, PolyPid's cash runway would extend into the second quarter of 2025.

The company also restructured its loan agreement with Kreos Capital VI, deferring over $2 million in repayments until April 2025, aligning with the expected timing for top-line results from the SHIELD II trial.

PolyPid hosted a Key Opinion Leader event, featuring Charles E. Edmiston, Ph.D., Emeritus Professor of Surgery at the Medical College of Wisconsin, who discussed key topics related to the prevention of SSIs. Key takeaways included the rise in SSIs to pre-COVID rates due to a rebound in elective surgeries and the normalization of the surgical environment. The event also highlighted how procedural and patient-related factors significantly increase the risk of SSIs, particularly when multiple risk factors are present. The long-term cost of a single colorectal SSI event remains substantial, ranging from $44,000 to $64,000 for commercial payers and $20,000 to $45,000 for Medicare.

In terms of corporate leadership, Ms. Dalit Hazan was promoted to Deputy Chief Executive Officer, alongside her role as Executive Vice President of R&D, Clinical, and Regulatory Affairs.

CEO Dikla Czaczkes Akselbrad expressed excitement over the recent clinical and operational progress. With around 320 patients enrolled in SHIELD II, she anticipates the interim analysis and remains on track for the top-line data readout in the first quarter of the next year. The recent $14 million financing, which included participation from multiple U.S. life sciences-focused investors, further supports the advancement of SHIELD II.

Financial results for the quarter ending June 30, 2024, showed an increase in R&D expenses to $4.8 million, up from $4.0 million in the same period in 2023, driven by the ramp-up of the SHIELD II trial. General and administrative expenses decreased to $1.1 million from $1.5 million, and marketing and business development expenses dropped to $0.3 million from $0.4 million, primarily due to ongoing cost-saving initiatives. The company reported a net loss of $6.3 million, or ($1.25) per share, compared to a net loss of $5.8 million, or ($3.95) per share, in the same period of 2023.

For the six months ending June 30, 2024, R&D expenses increased to $9.8 million from $7.8 million in the same period of 2023. General and administrative expenses decreased to $2.1 million from $3.1 million, and marketing and business development expenses decreased to $0.5 million from $0.7 million. The net loss for the six months was $12.7 million, or ($2.62) per share, compared to a net loss of $11.9 million, or ($10.85) per share, in the same period of 2023.

As of June 30, 2024, PolyPid had $9.3 million in cash and cash equivalents and short-term deposits, compared to $5.3 million on December 31, 2023. This does not include the $8.1 million from the PIPE financing, which closed in August 2024. The company expects its cash balance to be sufficient to fund operations into the first quarter of 2025, excluding potential additional funds from warrant exercises.