The Company is in Advanced Stages of Commercial U.S. Partnership Discussions for D-PLEX
Positive FDA Pre-NDA Feedback Supports Rolling NDA Review; Submission Expected to Begin by the End of the First Quarter of 2026
Conference Call Scheduled for Today at 8:30 AM ET
PETACH TIKVA, Israel, Feb. 11, 2026 (GLOBE NEWSWIRE) -- PolyPid Ltd. (Nasdaq: PYPD) ("PolyPid" or the "Company"), an innovative biopharmaceutical company dedicated to improving patient outcomes by elevating treatment effectiveness, right where care begins, today provided a corporate update and reported financial results for the three months and full year ended December 31, 2025.
Recent Corporate Highlights:
-- Advancing Toward Commercialization: The Company made significant progress
towards finalizing a potential partnership in the United States for
D-PLEX , including moving into advanced stages of discussions.
-- Regulatory Momentum: Received positive feedback from the U.S. Food and
Drug Administration ("FDA") following the pre-New Drug Application
("NDA") meeting minutes for D-PLEX in the prevention of abdominal
colorectal surgical site infections ("SSIs") for a planned rolling NDA
submission beginning by the end of the first quarter of 2026.
-- Strengthened the Company's governance and leadership: Appointed Ms.
Brooke Story as Chairman of the Board of Directors, effective December
11, 2025. Ms. Story brings extensive leadership experience in medical
technology and surgical solutions, including senior executive roles at BD
(Becton, Dickinson and Company) and Medtronic PLC.
-- Participated in a virtual Key Opinion Leader event during the quarter,
featuring Dr. Steven D. Wexner, MD, PhD (Hon), FACS, FRCS (Eng, Ed), Hon
FRCS (Glasg, Eng, Ire), MAMSE, Executive Director and System Chief of
Colorectal Surgery for MedStar Health and a globally recognized leader in
colorectal surgery, to discuss the significant clinical and economic
burden of SSIs and the potential role of D-PLEX in improving surgical
outcomes based on the positive results of the Phase 3 SHIELD II trial.
-- Unveiling the Kynatrix$(TM)$ Technology: Over the past years, PolyPid has
significantly expanded its drug delivery capabilities beyond the original
PLEX technology. These advancements include the ability to support new
therapeutic areas and delivery approaches, with the first test case being
the Company's expansion into metabolic diseases through an ultra
long-acting GLP-1 receptor agonist program. These advancements have
generated additional intellectual property beyond PLEX and are now
unified under the newly introduced Kynatrix(TM) technology.
"2025 was a pivotal year for PolyPid as we successfully completed the SHIELD II Phase 3 trial and advanced D-PLEX into the final stages of regulatory approval," said Dikla Czaczkes Akselbrad, Chief Executive Officer of PolyPid. "Following our positive Phase 3 results and progress made in the past quarter, we have moved into advanced stage discussions for potential commercial partnership in the U.S., reflecting the growing recognition of D-PLEX 's clinical and commercial value. At the same time, positive engagement with the FDA, including agreement on a rolling NDA review, further advanced our regulatory path as we work toward an NDA submission beginning by end of the first quarter of 2026. We believe 2026 has the potential to be a transformative year for PolyPid, marking our transition from late-stage development into full commercial execution, and we look forward to providing updates as these developments occur."
Financial results for three months ended December 31, 2025
-- Research and development ("R&D") expenses for the three months ended
December 31, 2025, were $6.2 million, compared to $7.0 million in the
same three-month period of 2024. The decrease in R&D expenses was
primarily driven by the completion of the SHIELD II Phase 3 trial and the
Company's transition toward regulatory submissions.
-- General and administrative ("G&A") expenses for the three months ended
December 31, 2025, were $1.8 million, compared to $1.0 million for the
same period of 2024.
-- Marketing and business development expenses for the three months ended
December 31, 2025, were $0.6 million, compared to $0.2 million in the
same period of 2024.
-- For the three months ended December 31, 2025, the Company had a net loss
of $8.5 million, or ($0.41) per share, compared to a net loss of $8.5
million, or ($1.13) per share, in the three-month period ended December
31, 2024.
Financial results for the full year ended December 31, 2025
-- R&D expenses for the twelve months ended December 31, 2025, were $23.8
million, compared to $22.8 million for the same twelve-month period of
2024. The increase was primarily driven by continued activities related
to the completion of the SHIELD II Phase 3 trial, along with regulatory
preparation efforts and advancement of the Company's development
programs.
-- G&A expenses for the twelve months ended December 31, 2025, were $7.2
million, compared to $4.3 million for the same period of 2024. The
increase was primarily due to non-cash expenses related to
performance-based options ("PSUs"), following the successful SHIELD II
Phase 3 trial, which triggered the vesting of the PSUs.
-- Marketing and business development expenses for the twelve months ended
December 31, 2025, were $2.0 million, compared to $0.9 million for the
same period of 2024, primarily due to increased business development and
commercial preparation efforts.
-- For the twelve months ended December 31, 2025, the Company had a net loss
of $34.2 million, or ($2.09) per share, compared to a net loss of $29.0
million, or ($4.91) per share, in the twelve-month period ended December
31, 2024.
Balance Sheet Highlights
-- As of December 31, 2025, the Company had cash, cash equivalents, and
short-term deposits of $12.9 million, compared to $15.6
million on December 31, 2024.
-- Subsequent to the end of the quarter, several long-time shareholders
exercised warrants ahead of the warrants' expiration date at prices
ranging between $3.61 per share (for the warrants with an expiration date
of August 2026) and $4.50 per share (for the warrants with an expiration
date of June 2027), generating $3.7 million in additional proceeds,
further strengthening the Company's balance sheet.
-- The Company believes that its current cash balance will be sufficient to
fund operations into the second half of 2026 and through several
significant upcoming potential milestones.
Conference Call Dial-In & Webcast Information:
Date: Wednesday, February 11, 2026
Time: 8:30 AM Eastern Time
Conference Call: https://register-conf.media-server.com/register/B
I793c5305462d49cea4ba91529d2636bf
Webcast: https://edge.media-server.com/mmc/p/izp7gdk6
About PolyPid
PolyPid Ltd. (Nasdaq: PYPD) is an innovative biopharmaceutical company dedicated to elevating treatment effectiveness, right where care begins. The Company develops long-acting, controlled-release drugs designed to deliver therapy precisely at the site of care, addressing critical unmet medical needs across a wide and diverse pipeline spanning surgical care, metabolic diseases, and beyond. PolyPid's lead product, D-PLEX , successfully met its primary and all key secondary endpoints in the landmark Phase 3 SHIELD II trial for the prevention of surgical site infections. Guided by a commitment to precision and innovation, PolyPid is redefining how therapies perform and raise the standard of patient care.
For additional Company information, please visit http://www.polypid.com and follow us on Twitter $(X)$ and LinkedIn.
Forward-looking Statements
This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act and other securities laws. Words such as "expects," "anticipates," "intends," "plans," "believes," "seeks," "estimates" and similar expressions or variations of such words are intended to identify forward-looking statements. For example, the Company is using forward-looking statements when it discusses its regulatory strategy and planned timing for the submission of an NDA for D-PLEX , including the use of a rolling NDA review, advanced stages of commercial U.S. partnership discussions for D-PLEX , the potential role of D-PLEX in improving surgical outcomes, the Company's evolution toward commercialization, the growing recognition of D-PLEX 's clinical and commercial value, its belief that 2026 has the potential to be a transformative year for the Company, marking its transition from late-stage development into full commercial execution, and its expectation that current cash resources will be sufficient to fund operations into the second half of 2026 and through several significant upcoming potential milestones. Forward-looking statements are not historical facts, and are based upon management's current expectations, beliefs and projections, many of which, by their nature, are inherently uncertain. Such expectations, beliefs and projections are expressed in good faith. However, there can be no assurance that management's expectations, beliefs and projections will be achieved, and actual results may differ materially from what is expressed in or indicated by the forward-looking statements. Forward-looking statements are subject to risks and uncertainties that could cause actual performance or results to differ materially from those expressed in the forward-looking statements. For a more detailed description of the risks and uncertainties affecting the Company, reference
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